Generated Narrative: CodeSystem ncit-cs This case-insensitive code system http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl provides a fragment that includes following codes in a Part Of hierarchy: Lvl Code Display Definition 1 C20189 Property or Attribute A distinguishing quality or prominent aspect of a person, object, action, process, or substance. 2 C48191 Information Knowledge derived from study, experience, or instruction that has been gathered or received by communication. 3 C60776 Contact Information Information regarding the means of contacting a person or group. 4 C218693 Designated Medical Expert Contact Information The contact information for the sponsor's representative who can advise on specific trial-related medical questions or problems. 2 C25162 Code A symbol or combination of symbols which is assigned to the members of a collection. 3 C20108 Country Code An alphanumeric system designed to identify countries. The ISO 3166 standard includes a two letter representation, a three letter representation, and a 3 number representation. The last two are identical to the UN system. The US State Department system maintains a separate two letter representation code set. 4 C54641 Alpha-2 Country Code The two-letter country codes specified by the ISO 3166-1 country code standard. 4 C54642 Alpha-3 Country Code The three-letter country codes specified by the ISO 3166-1 country code standard. 4 C54640 Numeric Country Code The numeric, three-digit country codes specified by the ISO 3166-1 country code standard. 4 C165131 Study Country Code no definition found 2 C41009 Qualifier A term that helps define and render a concept unique. 3 C21514 Temporal Qualifier Terms used to indicate units of time or other terms associated with time. 4 C25164 Date The particular day, month and year an event has happened or will happen. 5 C71476 Approval Date A date of an official approbation, recognition, or acceptance as satisfactory. 6 C132352 Protocol Approval by Sponsor Date The date that the sponsor approved a version of the protocol. 5 C93702 Version Date The date (and time) on which an entity is versioned. 6 C93813 Document Version Date The date on which the document is versioned. 3 C27993 General Qualifier A term that helps define and render another concept unique. 4 C17998 Unknown Not known, observed, recorded; or reported as unknown by the data contributor. 5 C150003 Unknown Transformation It is unknown whether any transformation of the product takes place. 4 C48655 Missing Value Reason A specific reason explaining why a meaningful value is not available. A meaningful value answers the question posed by a Data Element Concept. In contrast, a Missing Value Reason answers the implicit question "Why is there no 'meaningful' value?", when there is none. 5 C48660 Not Applicable Determination of a value is not relevant in the current context. 4 C17649 Other Different than the one(s) previously specified or mentioned. 4 C68846 Global Covering or affecting the whole of a system. 4 C217026 Not Global Covering or affecting only a portion of the entire system. 4 C218489 By Cohort Covering or affecting a cohort of individuals. 3 C13442 Anatomy Qualifier An adjectival term used to specify a region of the body or other concepts associated with the body. 4 C41065 Locally To a restricted area (of the body). 2 C25341 Location A position, site, or point in space where something can be found. 3 C222063 Location of Medical Expert Contact Information The physical or virtual location of the medical expert (as designated by the sponsor) contact information. 3 C218484 Location of Sponsor Approval Date The physical or virtual location of the date on which the sponsor approved the current version of the protocol. 3 C222064 Location of Sponsor Signatory Information The physical or virtual location of the sponsor signatory information. 1 C43431 Activity An active process; excludes processes and mechanisms which fulfill biological functions. 2 C16326 Behavior The actions or reactions of an object or organism, usually in relation to the environment or surrounding world of stimuli. 3 C16452 Communication The exchange of information between objects, people, or groups. 4 C82658 Communication Response A statement (either spoken or written) that is made in reply to a question, request, criticism, or accusation. 5 C49149 Answer A statement (either spoken or written) that is made in reply to a question or request or criticism or accusation; a statement that solves a problem or explains how to solve the problem. 6 C49487 No The non-affirmative response to a question. 6 C49488 Yes The affirmative response to a question. 3 C19683 Personal Behavior The observable response of a person. 4 C16735 Informed Consent Consent by a patient to a surgical or medical procedure or participation in a clinical study after achieving an understanding of the relevant medical facts and the risks involved. 2 C16203 Clinical or Research Activity Any specific activity undertaken during the course of a clinical study or research protocol. 3 C15429 Research Activity Systematic investigation into a subject in order to discover facts, establish or revise a theory, or develop a plan of action based on the facts discovered. 4 C63536 Study A detailed examination, analysis, or critical inspection of a subject designed to discover facts about it. 5 C15206 Clinical Study Research conducted with human subjects or on material of human origin in which an investigator directly interacts with human subjects; includes development of new technologies, study of mechanisms of human diseases, therapy, clinical trials, epidemiologic, behavior, and health services research. 6 C208216 Clinical Study by Type A clinical study classified by its type, such as observational studies, case-control studies, cohort studies, cross-sectional studies, and clinical trials. 7 C71104 Clinical Trial A research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. 8 C70820 Clinical Trial by Phase A description of a clinical trial by the phase of the trial (I, II, III, or IV). 9 C54721 Early Phase 1 Trial Exploratory clinical trials, in a small number of participants, that are conducted early in Phase 1. The investigational trial intervention is administered at a low dose for a limited time. Early Phase 1 trials provide insights into a variety of parameters such as pharmacokinetic, pharmacodynamic, and other biomarkers. They involve limited human exposure, have no therapeutic or diagnostic intent, and are not intended to assess clinical tolerability. 9 C15600 Phase I Trial Exploratory clinical trials that may be first-in-human, conducted in a small number of patients or healthy volunteers to evaluate clinical safety, tolerability, or therapeutic intent (pharmacokinetics and pharmacodynamics) of an investigational trial intervention. 10 C142564 First-in-Human Study A type of phase 1 clinical trial in which the test product is administered to human beings for the first time. 10 C199990 Phase Ia Trial A type of phase 1 trial with a single ascending dose (dose escalation) in a small group of patients (in comparison to a Phase 1b). 10 C199989 Phase Ib Trial A type of phase 1 trial with multiple ascending doses (dose expansion) in a larger group of patients (in comparison to a Phase 1a). 9 C15693 Phase I/II Trial A single clinical trial that combines elements of Phase 1 and Phase 2 trials, which may begin as a Phase 1 trial and transition into Phase 2 based upon predetermined criteria. 10 C15835 Phase I and II Vaccine Trials Select candidate vaccines or concepts suitable for Phase I and Phase II trials and conduct these trials. 9 C198366 Phase I/II/III Trial A study that begins as a Phase I study and transitions into Phases II and III based upon successful completion of each previous portion. 9 C198367 Phase I/III Trial A study that begins as a Phase I study and transitions into a Phase III study upon successful completion of the Phase I portion. 9 C15601 Phase II Trial Exploratory trials conducted to evaluate the safety and efficacy of the investigational trial intervention in patients with the disease or condition. Objectives may include, but are not limited to, clinical pharmacology, dose-ranging (dose-response, frequency of dosing), type of patients, or other characteristics of safety and efficacy. 10 C49686 Phase IIa Trial A clinical research protocol generally referred to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question. 10 C49688 Phase IIb Trial A clinical research protocol generally referred to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. 9 C15694 Phase II/III Trial A type of clinical study that combines elements characteristic of traditional Phase II and Phase III trials. 9 C217024 Phase II/III/IV Trial A study that begins as a Phase II study and transitions into Phases III and IV based upon successful completion of each previous portion. 9 C15602 Phase III Trial Confirmatory trials conducted to demonstrate safety, efficacy and tolerability of the investigational trial intervention in patients with the disease or condition. Their objectives are to evaluate the overall benefit-risk relationship and may provide substantial evidence for regulatory approval and product information. 10 C15873 Phase III Large Scale Vaccine Trial Select suitable vaccine candidates and support efficacy trials when appropriate criteria are met. 10 C49687 Phase IIIa Trial A classification typically assigned retrospectively to a Phase III trial after regulatory authorities determined the need for a Phase III B trial. 10 C49689 Phase IIIb Trial A type of Phase III trial executed near the time of approval to elicit additional findings. This type of trial may be required as a condition of regulatory authority approval. 9 C217025 Phase III/IV Trial A type of clinical study that combines elements characteristic of traditional Phase III and Phase IV trials. 9 C15603 Phase IV Trial Post-approval (or post-marketing) trials conducted to further evaluate the safety and efficacy of an investigational trial intervention in its approved indication and may be conducted to address a regulatory requirement. These studies may explore use of the investigational trial intervention in the real-world setting of clinical practice and may also inform health economics and health technology assessments. 2 C16847 Technique A practiced and regimented skill or series of actions. 3 C20368 Research Technique Technique used in the laboratory for scientific research. 4 C60819 Assay A qualitative or quantitative analysis performed to determine the amount of a particular constituent in a sample or the biological or pharmacological properties or activity of a drug or substance. 5 C15958 In Vitro Assay Assay conducted in an artificial environment, such as in a test tube, under a defined and controlled set of solvent and solute conditions. 6 C17635 Tumor Necrosis Factor Assay An immunoassay to detect Tumor Necrosis Factor (TNF), which is a potent lymphoid factor, and exerts cytotoxic effects on a wide range of tumor cells and other target cells. Utilizes monoclonal antibody to TNF immobilized on microtitre plate. 1 C20181 Conceptual Entity An organizational header for concepts representing mostly abstract entities. 2 C19160 Occupation or Discipline A grouping of occupations and fields of study. 3 C25193 Occupation The principal activity that a person does to earn money. 4 C25392 Manufacturer A person, enterprise, or entity that produces finished goods. 5 C156625 Device Manufacture A person or entity that designs, manufactures, fabricates, assembles, or processes a finished device. 2 C49154 Statement A verbal and/or written message that asserts, affirms, or declares something. 3 C218474 Protocol Amendment Details Statement no definition found 4 C218485 Protocol Not Amended This protocol has not been amended. 4 C218488 Protocol Previously Amended See Summary of Changes Before the Table of Contents This protocol has been amended previously. The Protocol Amendment Summary of Changes for the current amendment is located directly before the Table of Contents. Prior amendment(s) to this protocol are listed in the table below, beginning with the most recent. 4 C218487 Protocol Previously Amended, Details Presented This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s). 4 C218486 First Protocol Amendment This is the first protocol amendment. 2 C25180 Indicator An event, entity or condition that typically characterizes a prescribed environment or situation and determines or aids in determining whether certain stated circumstances exist or criteria are satisfied. 3 C218673 Amendment Scope Global Applicability Indicator A descriptive indicator of whether the amendment scope applies globally across the trial. 3 C218672 Original Protocol Indicator An indication as to whether the protocol document reflects the original version of the protocol. 2 C25257 Phase A distinguishable part, a stage in a series of events or in a process of development, e.g. any of the varying aspects or stages in course of a disease; a fraction of a cycle. 3 C48281 Trial Phase Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment for safety in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people to measure whether the treatment actually benefits patients, and whether its benefits exceed its risks; and Phase IV takes place after the drug or treatment has been licensed and marketed. 2 C25638 Reason An explanation of the cause of some phenomenon or action. 3 C207457 Study Amendment Reason The rationale for the change(s) to, or formal clarification of, a protocol. 4 C218497 Change in Standard Of Care Amendment Reason A change in the standard of care necessitates a change(s) to, or formal clarification of, the protocol. 4 C218496 Change in Strategy Amendment Reason A change in the study purpose or intent of the scientific plan necessitates a change(s) to, or formal clarification of, the protocol. 4 C218495 IMP Addition Amendment Reason The addition of an investigational medicinal product to a clinical trial design necessitates a change(s) to, or formal clarification of, the protocol. 4 C218501 Inconsistency and/or Error in the Protocol Amendment Reason An error or inconsistency in the protocol necessitates a change(s) to, or formal clarification of, the protocol. 4 C218499 Investigator/Site Feedback Amendment Reason Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol. 4 C218492 IRB/IEC Feedback Amendment Reason Feedback from the institutional review board or independent ethics committee necessitates a change(s) to, or formal clarification of, the protocol. 4 C218494 Manufacturing Change Amendment Reason A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol. 4 C218498 New Data Available (Other Than Safety Data) Amendment Reason Previously unavailable data (other than safety data) becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. 4 C218491 New Regulatory Guidance Amendment Reason A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol. 4 C218493 New Safety Information Available Amendment Reason Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. 4 C218502 Protocol Design Error Amendment Reason A protocol design error necessitates a change(s) to, or formal clarification of, a document. 4 C218500 Recruitment Difficulty Amendment Reason Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol. 4 C218490 Regulatory Agency Request to Amend Amendment Reason A regulatory agency has expressed a need for a change(s) to, or formal clarification of, the protocol. 2 C25190 Person A human being. 3 C198995 Person by OccupationType An individual who is classified by their work type. 4 C17445 Caregiver The primary person in charge of the care of a patient, usually a family member or a designated health care professional. 5 C53427 Other Caregiver Different from the previously specified or mentioned type of person who has primary responsibility for the assistance and supervision for an individual. 3 C198997 Person by Activity Type A person described by an activity with which they are engaged. 4 C48355 Sponsor A person or organization that supports or champions something. 5 C71136 Regulatory Application Sponsor The party who submits a marketing application to FDA for approval of a drug, device, or biologic product. An applicant is the person or entity who assumes responsibility for the marketing of a new medical product, including responsibility for compliance with applicable provisions of the Federal Food, Drug, and Cosmetic Act and related regulations. The sponsor is usually an individual, partnership, corporation, government agency, manufacturer or scientific institution. 5 C142679 Secondary Sponsor Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on sponsorship responsibilities. (WHO) 5 C93478 Study Legal Sponsor A sponsor that initiates the investigation and is legally responsible for the study. 5 C215669 Study Co-Sponsor An individual, company, institution, or organization that is designated by the study sponsor as a vested partner in the study. 5 C215670 Local Legal Sponsor The sponsor's legal representative at a geographical region within which the sponsor has no legal presence. (ICH M11) 5 C70793 Clinical Study Sponsor An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary) 6 C187708 Commercial Clinical Trial Sponsor A person or organization that takes responsibility for a trial which is part of the development program for a marketing authorization of a medicinal product at the time of the application. (EUDRACT) 6 C187709 Non-commercial Clinical Trial Sponsor A person or organization that takes responsibility for a trial that is not part of the development program for a marketing authorization of a medicinal product at the time of the application. (EUDRACT) 6 C70794 Primary Clinical Study Sponsor The individual, organization, group or other legal person taking responsibility for securing the arrangements to initiate and/or manage a study (including arrangements to ensure that the study design meets appropriate standards and to ensure appropriate conduct and reporting). In commercial trials, the primary sponsor is normally the main applicant for regulatory authorization to begin the study. It may or may not be the main funder. 6 C70795 Secondary Clinical Study Sponsor Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship. A secondary sponsor may have agreed -to take on all the responsibilities of sponsorship jointly with the primary sponsor; or to form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group; or to act as the sponsor's legal representative in relation to some or all of the study sites; or to take responsibility for the accuracy of study registration information submitted. 2 C43359 Group Any number of entities (members) considered as a unit. 3 C17005 Population Group A group of individuals united by a common factor (e.g., geographic location, ethnicity, disease, age, sex). 4 C60758 Personnel Persons employed in any field. 5 C17089 Research Personnel People engaged in research. 6 C51876 Sponsor Medical Expert A physician or health care provider selected by the sponsor to be readily available to advise clinical trial officials on trial related medical questions or problems. 6 C51824 Evaluator A person who determines the significance, worth, or condition of something by careful appraisal and study. 7 C207599 Outcomes Assessor The individual who evaluates the outcome(s) of interest. 6 C25936 Investigator An individual who conducts scientific research. In a clinical setting this individual actually conducts and/or supervises the clinical investigation and study-related procedures. The investigator monitors the safety of the trial subjects and investigational staff (under whose immediate direction an agent is administered or dispensed to a subject). The investigator collects and analyses data and study documents, and provides reports in compliance with applicable requirements. 7 C70722 Investigator by Role in Study The characteristic that defines the responsibility of the investigator on a particular study. 8 C51812 Co-Investigator One of two or more scientists working together on a research project. A person that equally contributes to the preparation of the protocol, and shares the responsibilities of this position, including medical monitoring (particularly toxicity/safety), liaison with statisticians over analysis, and the generation of a report containing the results. 8 C51818 Coordinating Investigator A research scientist whose task is to see that work, or events, goes harmoniously. 9 C154706 National Coordinating Investigator In the case of a multinational study, a person who has the responsibilities of the sponsor of the study in his/her country and will be responsible for the coordination of the principal investigators at different sites within that member state. (EMA) 8 C51825 Grant Investigator An individual designated by the grantee to take part in the conduction of the study or to participate in a scientific activity being supported by the grant. 8 C19924 Principal Investigator An investigator who is responsible for all aspects of the conduct of a study. 9 C51817 Contract Principal Investigator A scientist or health care professional that has a financial agreement, as outlined in a binding statement of work, with the sponsor to bear full and ultimate responsibility for the scientific, administrative, ethical, legal, technical, and fiscal aspects of the study, and for day-to-day management of the scientific project, as well as for documenting and reporting its results. 9 C63403 Funded Principal Investigator The investigator named on the award document. This investigator has full and ultimate responsibility for all research conducted under the award. 9 C51826 Grant Principal Investigator An individual designated by the grantee to direct the project or activity being supported by the grant. He or she is responsible for the scientific, legal, administrative, and technical aspects of the grant and accountable to the grantee for the proper conduct of the project or activity. The Principle Investigator (PI) must have a formal written appointment with the applicant organization, which must be in the form of an official relationship between the parties, but need not involve a salary or other form of remuneration. The PI is a member of the grantee team responsible for ensuring compliance with the financial and administrative aspects of the award and with organizational as well as Federal requirements. 8 C51856 Protocol Lead Investigator Primary clinical researcher of a clinical trial, ultimately responsible for all aspects in the conduct of a study, but has special responsibility with regard to the implementation and administration of the study design, and methodology of a trial. 8 C51875 Site Representative Investigator The investigator who officially represents a clinical site that participates in a multicentral clinical trial. The responsibilities of the official include the management of site compliance with rules and regulations and attention to personnel and patient requisites. 8 C54622 Subinvestigator Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). 7 C214478 Non-Physician Investigator A researcher who does not have a degree in medicine. 7 C93404 Study Site Investigator A researcher at a study site who oversees multiple aspects of the study at a site, including protocol submission for IRB approval, participant recruitment, informed consent, data collection, and analysis. 7 C198656 Treating Investigator The study investigator in charge of administering treatment to study participants. 2 C48910 Subject Some matter, situation, or event that is thought about, written about, or discussed. 3 C79916 Investigative Subject An entity, either biologic or otherwise, of interest in an investigation. 4 C41189 Study Subject A matter or an individual that is observed, analyzed, examined, investigated, experimented upon, or/and treated in the course of a particular study. 5 C142710 Study Participant Any individiual that has a role in a study, including study personnel and study subjects. 6 C188266 High Risk Study Participant A participant in a study that presents a greater than moderate risk due to the increased probability for generating serious adverse events. Since there is a probability of an event that is serious and prolonged or permanent occurring as a result of study participation, the participant will require high intensity monitoring. 2 C25198 Record Anything (e.g., a document) providing permanent evidence of or information about past events. 3 C19498 Document A physical object, or electronic counterpart, that is characterized by containing writing which is meant to be human-readable. 4 C42651 Protocol A rule which guides how an activity should be performed. 5 C70705 Component of Study Protocol A component of a plan on which a study is based. 6 C181183 Protocol Statement A written message providing an official assurance, account, or assertion within the study protocol. 7 C181236 Protocol Confidentiality Statement A written message within the study protocol that asserts a statement of non-disclosure, such that information contained within the protocol document may only be shared with authorized parties. 4 C25678 Signature Individual's name or personal mark, used to sign documents and employed to signify that the writing which precedes accords with one's wishes and intentions; having a handwritten signature. 5 C222014 Sponsor Signatory A block of text containing the name and signature of the sponsor's signatory, along with the signature date. 4 C25364 Identifier One or more characters used to identify, name, or characterize the nature, properties, or contents of a thing. 5 C83081 Study Site Identifier A sequence of characters used to identify, name, or characterize the study site. 5 C218674 Region Identifier A sequence of characters used to identify and/or name the region. 5 C218690 Other Regulatory or Clinical Trial Identifier A sequence of characters assigned by a regulatory agency or other health authority that is used to identify a clinical trial, and that is different than the one(s) previously specified or mentioned. 5 C96095 Product Identifier no definition found 6 C218675 Sponsor's Investigational Product Code A symbol or combination of symbols that are assigned by the sponsor to uniquely identify an experimental intervention. 5 C70663 Unique Identifier A set of characters used as a code that is unique in the context or the system for which it is created. It serves as a means of identification and reference (often instead of a name) for an entity, person, thing, function, procedure, activity, variable, or body of data. 6 C98714 Clinical Trial Registry Identifier A sequence of letters, numbers, or other characters that uniquely identifies a clinical trial within a clinical trial registry. 7 C172240 Clinicaltrials.gov Identifier The unique alphanumeric identifier for a trial as assigned by the Clinicaltrials.gov Protocol Registration and Results System (PRS). 8 C127792 Clinicaltrials.gov NCT Number for the Expanded Access Record The unique alphanumeric identifier for a study with associated expanded access record, as assigned by the clinicaltrials.gov PRS system. 5 C132299 Protocol Identifier A sequence of letters, numbers, or other characters that uniquely identifies a study protocol. 6 C132351 Sponsor Protocol Identifier A unique code, which is assigned by the sponsor, that identifies a specific protocol. 5 C218689 WHO/UTN Number A sequence of characters used to identify a clinical trial, as assigned by the World Health organization's International Clinical Trial's Registry Platform (ICTRP). 5 C218477 Amendment Identifier A sequence of characters used to uniquely identify a protocol amendment. 5 C218688 NMPA IND Number A sequence of characters used to identify a clinical trial under an Investigational New Drug (IND) application, as assigned by the Chinese National Medicinal Products Administration (NMPA). 5 C218686 US FDA Investigational Device Exemption Application Number A sequence of characters used to identify a clinical trial under an Investigational Device Exemption (IDE) application, as assigned by the US Food and Drug Administration. 5 C218684 EU Clinical Trial Register Number A sequence of characters used to identify a clinical trial, as assigned by the Clinical Trials Information System (CTIS) of the European Medicines Agency. 5 C218687 Japan Registry for Clinical Trials Number A sequence of characters used to identify a clinical trial, as assigned by the Japan Registry for Clinical Trials (JRCT) of the Ministry of Health, Labour and Welfare (MHLW) in Japan. 5 C218685 US FDA Investigational New Drug Application Number A sequence of characters used to identify a clinical trial under an Investigational New Drug (IND) application, as assigned by the US Food and Drug Administration. 4 C25704 Text The words of something written. 5 C207508 Narrative Content Text A textual representation of the narrative content. 5 C93703 Version Number Text A numeric character string that identifies a form or variant of a type or original. 6 C181232 Study Protocol Version Number A string of numerals that uniquely identifies a specific version of a study protocol. 4 C25407 Address A standardized representation of the location of a person, business, building, or organization. 5 C70946 Postal Address A physical location used by a person or organization for the purpose of receiving postal mail deliveries. 6 C93844 Health Care Provider Postal Address A contact point used to send physical forms of communication to the healthcare provider. 6 C93847 Healthcare Facility Postal Address A contact point used to send physical forms of communication to the healthcare facility. 6 C164841 Insured Person Postal Address no definition found 6 C93875 Organization Postal Address A contact point used to send physical forms of communication to the organization. 6 C164888 Organization Staff Role Postal Address no definition found 6 C93880 Organizational Contact Postal Address A contact point used to send physical forms of communication to the organizational contact. 6 C93983 Performer Postal Address A contact point used to send physical forms of communication to the performer. 6 C93990 Person Postal Address A contact point used to send physical forms of communication to the person. 6 C165044 Point Of Contact Postal Address no definition found 6 C94065 Research Staff Postal Address A contact point used to send physical forms of communication to the research staff. 6 C95395 Service Delivery Location Postal Address The postal address of the service delivery location. 6 C176376 Study Contact Postal Address A physical location used by a study contact for the purpose of receiving postal mail deliveries. 6 C165133 Study Country Personnel Postal Address no definition found 6 C94101 Study Personnel Postal Address A contact point used to send physical forms of communication to the study personnel. 6 C94147 Study Site Personnel Postal Address A contact point used to send physical forms of communication to the study site personnel. 5 C218677 Sponsor Legal Address The legally registered address of the trial sponsor. 5 C218679 Co-Sponsor Legal Address The legally registered address of the trial co-sponsor. 5 C218683 Device Manufacturer Legal Address The legally registered address of the device manufacturer. 5 C218681 Local Sponsor Legal Address The legally registered address of the sponsor's legal representative at a geographical region within which the sponsor has no legal presence. 2 C25480 Details Particulars considered individually and in relation to a whole. 3 C218694 Protocol Amendment Details Particulars about the protocol amendment, considered individually and in relation to a whole. 2 C42614 Name The words or language units by which a thing is known. 3 C218678 Co-Sponsor Name The literal identifier (i.e., distinctive designation) of the trial co-sponsor. 3 C218682 Device Manufacturer Name The literal identifier (i.e., distinctive designation) of the organization defined as being responsible for creating the device as stated on the package in which the product is supplied. 3 C218680 Local Sponsor Name The literal identifier (i.e., distinctive designation) of the sponsor's legal representative at a geographical region within which the sponsor has no legal presence. 3 C222495 Trial Sponsor Name The literal identifier (i.e., distinctive designation) of the trial sponsor. 3 C42774 Title An official descriptive name of a document, e.g. the long name of a study protocol provided by the study sponsor. 4 C132300 Protocol Title The name of a study protocol. 5 C132346 Official Protocol Title The formal, descriptive name of the protocol. 4 C93637 Public Title The title of the document intended for the general population. 5 C94105 Study Protocol Document Version Public Title The short descriptive name for the trial. 4 C49802 Trial Title The name of a clinical trial. 5 C207615 Brief Study Title The short descriptive name for the study. 5 C207618 Scientific Study Title A more extensive descriptive name of the study that is intended for medical professionals, written using medical and scientific language. 5 C207616 Official Study Title The formal descriptive name for the study. 5 C207617 Public Study Title The descriptive name of the study that is intended for the lay public, written in easily understood language. 3 C93495 Acronym The non-unique initials or abbreviated name used for identification. 4 C94108 Study Protocol Version Acronym The non-unique initials or abbreviated name used for identification of the study protocol document version. 4 C207646 Study Acronym The non-unique initials or abbreviated name used for identification of the study. 3 C71898 Proprietary Name The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies. 3 C97054 Generic Name Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name. 4 C202465 Compendial Name A name within a pharmaceutical compendium that designates a small or large molecule substance that complies with compendial standards for strength, quality, and purity. (USP Nomenclature Guidelines) 4 C142585 International Nonproprietary Name A unique, internationally consistent and globally recognized name which identifies pharmaceutical substances or active pharmaceutical ingredients and is public property. 4 C96973 United States Adopted Name A unique nonproprietary name assigned to drugs and biologics by the United States Adopted Names Council (USAN). 4 C203358 USP-NF Established Name A unique nonproprietary name assigned to drugs and biologics by the United States Pharmacopeia (USP) or excipients by the National Formulary (NF). 2 C19067 Title An identifying designation. 3 C215610 Document Content Reference Section Title An identifying designation for a particular section for the document content reference. 4 C217359 Protocol Section Title An identifying designation for a section within a protocol document. 5 C217360 ICH M11 Protocol Section Title An identifying designation for a section within the ICH M11 protocol template document. 6 C218514 ICH M11 Protocol Section 1 PROTOCOL SUMMARY The title of section 1 of the ICH M11 protocol guideline: PROTOCOL SUMMARY. 6 C218515 ICH M11 Protocol Section 1.1 Protocol Synopsis The title of section 1.1 of the ICH M11 protocol guideline: Protocol Synopsis. 6 C218516 ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and Estimands The title of section 1.1.1 of the ICH M11 protocol guideline: Primary and Secondary Objectives and Estimands. 6 C218517 ICH M11 Protocol Section 1.1.2 Overall Design The title of section 1.1.2 of the ICH M11 protocol guideline: Overall Design. 6 C218518 ICH M11 Protocol Section 1.2 Trial Schema The title of section 1.2 of the ICH M11 protocol guideline: Trial Schema. 6 C218519 ICH M11 Protocol Section 1.3 Schedule of Activities The title of section 1.3 of the ICH M11 protocol guideline: Schedule of Activities. 6 C218625 ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS The title of section 10 of the ICH M11 protocol guideline: STATISTICAL CONSIDERATIONS. 6 C218626 ICH M11 Protocol Section 10.1 General Considerations The title of section 10.1 of the ICH M11 protocol guideline: General Considerations. 6 C218647 ICH M11 Protocol Section 10.10 Multiplicity Adjustments The title of section 10.10 of the ICH M11 protocol guideline: Multiplicity Adjustments. 6 C218648 ICH M11 Protocol Section 10.11 Sample Size Determination The title of section 10.11 of the ICH M11 protocol guideline: Sample Size Determination. 6 C218627 ICH M11 Protocol Section 10.2 Analysis Sets The title of section 10.2 of the ICH M11 protocol guideline: Analysis Sets. 6 C218628 ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables The title of section 10.3 of the ICH M11 protocol guideline: Analyses of Demographics and Other Baseline Variables. 6 C218629 ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s) The title of section 10.4 of the ICH M11 protocol guideline: Analyses Associated with the Primary Objective(s). 6 C218630 ICH M11 Protocol Section 10.4.1 Primary Objective The title of section 10.4.1 of the ICH M11 protocol guideline: Primary Objective. 6 C218631 ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method The title of section 10.4.1.1 of the ICH M11 protocol guideline: Statistical Analysis Method. 6 C218632 ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s) The title of section 10.4.1.2 of the ICH M11 protocol guideline: Handling of Data in Relation to Primary Estimand(s). 6 C218633 ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s) The title of section 10.4.1.3 of the ICH M11 protocol guideline: Handling of Missing Data in Relation to Primary Estimand(s) 6 C218634 ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis The title of section 10.4.1.4 of the ICH M11 protocol guideline: Sensitivity Analysis. 6 C218635 ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis The title of section 10.4.1.5 of the ICH M11 protocol guideline: Supplementary Analysis. 6 C218636 ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s) The title of section 10.5 of the ICH M11 protocol guideline: Analyses Associated with the Secondary Objective(s). 6 C218637 ICH M11 Protocol Section 10.5.1 Secondary Objective The title of section 10.5.1 of the ICH M11 protocol guideline: Secondary Objective. 6 C218638 ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method The title of section 10.5.1.1 of the ICH M11 protocol guideline: Statistical Analysis Method. 6 C218639 ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s) The title of section 10.5.1.2 of the ICH M11 protocol guideline: Handling of Data in Relation to Secondary Estimand(s). 6 C218640 ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s) The title of section 10.5.1.3 of the ICH M11 protocol guideline: Handling of Missing Data in Relation to Secondary Estimand(s). 6 C218641 ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis The title of section 10.5.1.4 of the ICH M11 protocol guideline: Sensitivity Analysis. 6 C218642 ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis The title of section 10.5.1.5 of the ICH M11 protocol guideline: Supplementary Analysis. 6 C218643 ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s) The title of section 10.6 of the ICH M11 protocol guideline: Analyses Associated with the Exploratory Objective(s). 6 C218644 ICH M11 Protocol Section 10.7 Safety Analyses The title of section 10.7 of the ICH M11 protocol guideline: Safety Analyses. 6 C218645 ICH M11 Protocol Section 10.8 Other Analyses The title of section 10.8 of the ICH M11 protocol guideline: Other Analyses. 6 C218646 ICH M11 Protocol Section 10.9 Interim Analyses The title of section 10.9 of the ICH M11 protocol guideline: Interim Analyses. 6 C218649 ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS The title of section 11 of the ICH M11 protocol guideline: TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS. 6 C218650 ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations The title of section 11.1 of the ICH M11 protocol guideline: Regulatory and Ethical Considerations. 6 C218663 ICH M11 Protocol Section 11.10 Protocol Deviations The title of section 11.10 of the ICH M11 protocol guideline: Protocol Deviations. 6 C218664 ICH M11 Protocol Section 11.11 Early Site Closure The title of section 11.11 of the ICH M11 protocol guideline: Early Site Closure. 6 C218665 ICH M11 Protocol Section 11.12 Data Dissemination The title of section 11.12 of the ICH M11 protocol guideline: Data Dissemination. 6 C218651 ICH M11 Protocol Section 11.2 Trial Oversight The title of section 11.2 of the ICH M11 protocol guideline: Trial Oversight. 6 C218652 ICH M11 Protocol Section 11.2.1 Investigator Responsibilities The title of section 11.2.1 of the ICH M11 protocol guideline: Investigator Responsibilities. 6 C218653 ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities The title of section 11.2.2 of the ICH M11 protocol guideline: Sponsor Responsibilities. 6 C218654 ICH M11 Protocol Section 11.3 Informed Consent Process The title of section 11.3 of the ICH M11 protocol guideline: Informed Consent Process. 6 C218655 ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening The title of section 11.3.1 of the ICH M11 protocol guideline: Informed Consent for Rescreening. 6 C218656 ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research The title of section 11.3.2 of the ICH M11 protocol guideline: Informed Consent for Use of Remaining Samples in Exploratory Research. 6 C218657 ICH M11 Protocol Section 11.4 Committees The title of section 11.4 of the ICH M11 protocol guideline: Committees. 6 C218658 ICH M11 Protocol Section 11.5 Insurance and Indemnity The title of section 11.5 of the ICH M11 protocol guideline: Insurance and Indemnity. 6 C218659 ICH M11 Protocol Section 11.6 Risk-Based Quality Management The title of section 11.6 of the ICH M11 protocol guideline: Risk-Based Quality Management. 6 C218660 ICH M11 Protocol Section 11.7 Data Governance The title of section 11.7 of the ICH M11 protocol guideline: Data Governance. 6 C218661 ICH M11 Protocol Section 11.8 Data Protection The title of section 11.8 of the ICH M11 protocol guideline: Data Protection. 6 C218662 ICH M11 Protocol Section 11.9 Source Records The title of section 11.9 of the ICH M11 protocol guideline: Source Records. 6 C218666 ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS The title of section 12 of the ICH M11 protocol guideline: APPENDIX: SUPPORTING DETAILS. 6 C218667 ICH M11 Protocol Section 12.1 Clinical Laboratory Tests The title of section 12.1 of the ICH M11 protocol guideline: Clinical Laboratory Tests. 6 C218668 ICH M11 Protocol Section 12.2 Country/Region-Specific Differences The title of section 12.2 of the ICH M11 protocol guideline: Country/Region-Specific Differences. 6 C218669 ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s) The title of section 12.3 of the ICH M11 protocol guideline: Prior Protocol Amendment(s). 6 C218670 ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS The title of section 13 of the ICH M11 protocol guideline: APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS. 6 C218671 ICH M11 Protocol Section 14 APPENDIX: REFERENCES The title of section 14 of the ICH M11 protocol guideline: APPENDIX: REFERENCES. 6 C218520 ICH M11 Protocol Section 2 INTRODUCTION The title of section 2 of the ICH M11 protocol guideline: INTRODUCTION. 6 C218521 ICH M11 Protocol Section 2.1 Purpose of Trial The title of section 2.1 of the ICH M11 protocol guideline: Purpose of Trial. 6 C218522 ICH M11 Protocol Section 2.2 Assessment of Risks and Benefits The title of section 2.2 of the ICH M11 protocol guideline: Assessment of Risks and Benefits. 6 C218523 ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation Strategy The title of section 2.2.2 of the ICH M11 protocol guideline: Risk Summary and Mitigation Strategy. 6 C218524 ICH M11 Protocol Section 2.2.2 Benefit Summary The title of section 2.2.1 of the ICH M11 protocol guideline: Benefit Summary. 6 C218525 ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit Assessment The title of section 2.2.3 of the ICH M11 protocol guideline: Overall Risk-Benefit Assessment. 6 C218526 ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS The title of section 3 of the ICH M11 protocol guideline: TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS. 6 C218527 ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s) The title of section 3.1 of the ICH M11 protocol guideline: Primary Objective(s) and Associated Estimand(s). 6 C218528 ICH M11 Protocol Section 3.1.1 Primary Objective The title of section 3.1.1 of the ICH M11 protocol guideline: Primary Objective. 6 C218529 ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s) The title of section 3.2 of the ICH M11 protocol guideline: Secondary Objective(s) and Associated Estimand(s). 6 C218530 ICH M11 Protocol Section 3.2.1 Secondary Objective The title of section 3.2.1 of the ICH M11 protocol guideline: Secondary Objective. 6 C218531 ICH M11 Protocol Section 3.3 Exploratory Objective(s) The title of section 3.3 of the ICH M11 protocol guideline: Exploratory Objective(s). 6 C218532 ICH M11 Protocol Section 3.3.1 Exploratory Objective The title of section 3.3.1 of the ICH M11 protocol guideline: Exploratory Objective. 6 C218533 ICH M11 Protocol Section 4 TRIAL DESIGN The title of section 4 of the ICH M11 protocol guideline: TRIAL DESIGN. 6 C218534 ICH M11 Protocol Section 4.1 Description of Trial Design The title of section 4.1 of the ICH M11 protocol guideline: Description of Trial Design. 6 C218535 ICH M11 Protocol Section 4.1.1 Stakeholder Input into Design The title of section 4.1.1 of the ICH M11 protocol guideline: Stakeholder Input into Design. 6 C218536 ICH M11 Protocol Section 4.2 Rationale for Trial Design The title of section 4.2 of the ICH M11 protocol guideline: Rationale for Trial Design. 6 C218537 ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s) The title of section 4.2.1 of the ICH M11 protocol guideline: Rationale for Estimand(s). 6 C218538 ICH M11 Protocol Section 4.2.2 Rationale for Intervention Model The title of section 4.2.2 of the ICH M11 protocol guideline: Rationale for Intervention Model. 6 C218539 ICH M11 Protocol Section 4.2.3 Rationale for Control Type The title of section 4.2.3 of the ICH M11 protocol guideline: Rationale for Control Type. 6 C218540 ICH M11 Protocol Section 4.2.4 Rationale for Trial Duration The title of section 4.2.4 of the ICH M11 protocol guideline: Rationale for Trial Duration. 6 C218541 ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design The title of section 4.2.5 of the ICH M11 protocol guideline: Rationale for Adaptive or Novel Trial Design. 6 C218542 ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis The title of section 4.2.6 of the ICH M11 protocol guideline: Rationale for Interim Analysis. 6 C218543 ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design Aspects The title of section 4.2.7 of the ICH M11 protocol guideline: Rationale for Other Trial Design Aspects. 6 C218544 ICH M11 Protocol Section 4.3 Trial Stopping Rules The title of section 4.3 of the ICH M11 protocol guideline: Trial Stopping Rules. 6 C218545 ICH M11 Protocol Section 4.4 Start of Trial and End of Trial The title of section 4.4 of the ICH M11 protocol guideline: Start of Trial and End of Trial. 6 C218546 ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of Trial The title of section 4.5 of the ICH M11 protocol guideline: Access to Trial Intervention After End of Trial. 6 C218547 ICH M11 Protocol Section 5 TRIAL POPULATION The title of section 5 of the ICH M11 protocol guideline: TRIAL POPULATION. 6 C218548 ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale The title of section 5.1 of the ICH M11 protocol guideline: Description of Trial Population and Rationale. 6 C218549 ICH M11 Protocol Section 5.2 Inclusion Criteria The title of section 5.2 of the ICH M11 protocol guideline: Inclusion Criteria. 6 C218550 ICH M11 Protocol Section 5.3 Exclusion Criteria The title of section 5.3 of the ICH M11 protocol guideline: Exclusion Criteria. 6 C218551 ICH M11 Protocol Section 5.4 Contraception The title of section 5.4 of the ICH M11 protocol guideline: Contraception. 6 C218552 ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential The title of section 5.4.1 of the ICH M11 protocol guideline: Definitions Related to Childbearing Potential. 6 C218553 ICH M11 Protocol Section 5.4.2 Contraception Requirements The title of section 5.4.2 of the ICH M11 protocol guideline: Contraception Requirements. 6 C218554 ICH M11 Protocol Section 5.5 Lifestyle Restrictions The title of section 5.5 of the ICH M11 protocol guideline: Lifestyle Restrictions. 6 C218555 ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions The title of section 5.5.1 of the ICH M11 protocol guideline: Meals and Dietary Restrictions. 6 C218556 ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions The title of section 5.5.2 of the ICH M11 protocol guideline: Caffeine, Alcohol, Tobacco, and Other Restrictions. 6 C218557 ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions The title of section 5.5.3 of the ICH M11 protocol guideline: Physical Activity Restrictions. 6 C218558 ICH M11 Protocol Section 5.5.4 Other Activity Restrictions The title of section 5.5.4 of the ICH M11 protocol guideline: Other Activity Restrictions. 6 C218559 ICH M11 Protocol Section 5.6 Screen Failure and Rescreening The title of section 5.6 of the ICH M11 protocol guideline: Screen Failure and Rescreening. 6 C218560 ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY The title of section 6 of the ICH M11 protocol guideline: TRIAL INTERVENTION AND CONCOMITANT THERAPY. 6 C218561 ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention The title of section 6.1 of the ICH M11 protocol guideline: Description of Investigational Trial Intervention. 6 C218580 ICH M11 Protocol Section 6.10 Concomitant Therapy The title of section 6.10 of the ICH M11 protocol guideline: Concomitant Therapy. 6 C218581 ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy The title of section 6.10.1 of the ICH M11 protocol guideline: Prohibited Concomitant Therapy. 6 C218582 ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy The title of section 6.10.2 of the ICH M11 protocol guideline: Permitted Concomitant Therapy. 6 C218562 ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen The title of section 6.2 of the ICH M11 protocol guideline: Rationale for Investigational Trial Intervention Dose and Regimen. 6 C218563 ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration The title of section 6.3 of the ICH M11 protocol guideline: Investigational Trial Intervention Administration. 6 C218564 ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification The title of section 6.4 of the ICH M11 protocol guideline: Investigational Trial Intervention Dose Modification. 6 C218565 ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose The title of section 6.5 of the ICH M11 protocol guideline: Management of Investigational Trial Intervention Overdose. 6 C218566 ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention The title of section 6.6 of the ICH M11 protocol guideline: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention. 6 C218567 ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention The title of section 6.6.1 of the ICH M11 protocol guideline: Preparation of Investigational Trial Intervention. 6 C218568 ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention The title of section 6.6.2 of the ICH M11 protocol guideline: Storage and Handling of Investigational Trial Intervention. 6 C218569 ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention The title of section 6.6.3 of the ICH M11 protocol guideline: Accountability of Investigational Trial Intervention. 6 C218570 ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding The title of section 6.7 of the ICH M11 protocol guideline: Investigational Trial Intervention Assignment, Randomisation and Blinding. 6 C218571 ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention The title of section 6.7.1 of the ICH M11 protocol guideline: Participant Assignment to Investigational Trial Intervention. 6 C218572 ICH M11 Protocol Section 6.7.2 Randomisation The title of section 6.7.2 of the ICH M11 protocol guideline: Randomisation. 6 C218573 ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding The title of section 6.7.3 of the ICH M11 protocol guideline: Measures to Maintain Blinding. 6 C218574 ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site The title of section 6.7.4 of the ICH M11 protocol guideline: Emergency Unblinding at the Site. 6 C218575 ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence The title of section 6.8 of the ICH M11 protocol guideline: Investigational Trial Intervention Adherence. 6 C218576 ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention The title of section 6.9 of the ICH M11 protocol guideline: Description of Noninvestigational Trial Intervention. 6 C218577 ICH M11 Protocol Section 6.9.1 Background Trial Intervention The title of section 6.9.1 of the ICH M11 protocol guideline: Background Trial Intervention. 6 C218578 ICH M11 Protocol Section 6.9.2 Rescue Therapy The title of section 6.9.2 of the ICH M11 protocol guideline: Rescue Therapy. 6 C218579 ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention The title of section 6.9.3 of the ICH M11 protocol guideline: Other Noninvestigational Trial Intervention. 6 C218583 ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL The title of section 7 of the ICH M11 protocol guideline: PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL. 6 C218584 ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants The title of section 7.1 of the ICH M11 protocol guideline: Discontinuation of Trial Intervention for Individual Participants. 6 C218585 ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention The title of section 7.1.1 of the ICH M11 protocol guideline: Permanent Discontinuation of Trial Intervention. 6 C218586 ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention The title of section 7.1.2 of the ICH M11 protocol guideline: Temporary Discontinuation of Trial Intervention. 6 C218587 ICH M11 Protocol Section 7.1.3 Rechallenge The title of section 7.1.3 of the ICH M11 protocol guideline: Rechallenge. 6 C218588 ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial The title of section 7.2 of the ICH M11 protocol guideline: Participant Discontinuation or Withdrawal from the Trial. 6 C218589 ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up The title of section 7.3 of the ICH M11 protocol guideline: Management of Loss to Follow-Up. 6 C218590 ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES The title of section 8 of the ICH M11 protocol guideline: TRIAL ASSESSMENTS AND PROCEDURES. 6 C218591 ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations The title of section 8.1 of the ICH M11 protocol guideline: Trial Assessments and Procedures Considerations. 6 C218592 ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures The title of section 8.2 of the ICH M11 protocol guideline: Screening/Baseline Assessments and Procedures. 6 C218593 ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures The title of section 8.3 of the ICH M11 protocol guideline: Efficacy Assessments and Procedures. 6 C218594 ICH M11 Protocol Section 8.4 Safety Assessments and Procedures The title of section 8.4 of the ICH M11 protocol guideline: Safety Assessments and Procedures. 6 C218595 ICH M11 Protocol Section 8.4.1 Physical Examination The title of section 8.4.1 of the ICH M11 protocol guideline: Physical Examination. 6 C218596 ICH M11 Protocol Section 8.4.2 Vital Signs The title of section 8.4.2 of the ICH M11 protocol guideline: Vital Signs. 6 C218597 ICH M11 Protocol Section 8.4.3 Electrocardiograms The title of section 8.4.3 of the ICH M11 protocol guideline: Electrocardiograms. 6 C218598 ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments The title of section 8.4.4 of the ICH M11 protocol guideline: Clinical Laboratory Assessments. 6 C218599 ICH M11 Protocol Section 8.4.5 Pregnancy Testing The title of section 8.4.5 of the ICH M11 protocol guideline: Pregnancy Testing. 6 C218600 ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring The title of section 8.4.6 of the ICH M11 protocol guideline: Suicidal Ideation and Behaviour Risk Monitoring. 6 C218601 ICH M11 Protocol Section 8.5 Pharmacokinetics The title of section 8.5 of the ICH M11 protocol guideline: Pharmacokinetics. 6 C218602 ICH M11 Protocol Section 8.6 Biomarkers The title of section 8.6 of the ICH M11 protocol guideline: Biomarkers. 6 C218603 ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics The title of section 8.6.1 of the ICH M11 protocol guideline: Genetics, Genomics, Pharmacogenetics and Pharmacogenomics. 6 C218604 ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers The title of section 8.6.2 of the ICH M11 protocol guideline: Pharmacodynamic Biomarkers. 6 C218605 ICH M11 Protocol Section 8.6.3 Other Biomarkers The title of section 8.6.3 of the ICH M11 protocol guideline: Other Biomarkers. 6 C218606 ICH M11 Protocol Section 8.7 Immunogenicity Assessments The title of section 8.7 of the ICH M11 protocol guideline: Immunogenicity Assessments. 6 C218607 ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics The title of section 8.8 of the ICH M11 protocol guideline: Medical Resource Utilisation and Health Economics. 6 C218608 ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS The title of section 9 of the ICH M11 protocol guideline: ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS. 6 C218609 ICH M11 Protocol Section 9.1 Definitions The title of section 9.1 of the ICH M11 protocol guideline: Definitions. 6 C218610 ICH M11 Protocol Section 9.1.1 Definitions of Adverse Events The title of section 9.1.1 of the ICH M11 protocol guideline: Definitions of Adverse Events. 6 C218611 ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse Events The title of section 9.1.2 of the ICH M11 protocol guideline: Definitions of Serious Adverse Events. 6 C218612 ICH M11 Protocol Section 9.1.3 Definitions of Product Complaints The title of section 9.1.3 of the ICH M11 protocol guideline: Definitions of Product Complaints. 6 C218613 ICH M11 Protocol Section 9.1.3.1 Definitions of Medical Device Product Complaints The title of section 9.1.3.1 of the ICH M11 protocol guideline: Definitions of Medical Device Product Complaints. 6 C218614 ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and Reporting The title of section 9.2 of the ICH M11 protocol guideline: Timing and Procedures for Collection and Reporting. 6 C218615 ICH M11 Protocol Section 9.2.1 Timing The title of section 9.2.1 of the ICH M11 protocol guideline: Timing. 6 C218616 ICH M11 Protocol Section 9.2.2 Collection Procedures The title of section 9.2.2 of the ICH M11 protocol guideline: Collection Procedures. 6 C218617 ICH M11 Protocol Section 9.2.3 Reporting The title of section 9.2.3 of the ICH M11 protocol guideline: Reporting. 6 C218618 ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting Requirements The title of section 9.2.3.1 of the ICH M11 protocol guideline: Regulatory Reporting Requirements. 6 C218619 ICH M11 Protocol Section 9.2.4 Adverse Events of Special Interest The title of section 9.2.4 of the ICH M11 protocol guideline: Adverse Events of Special Interest. 6 C218620 ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs The title of section 9.2.5 of the ICH M11 protocol guideline: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs. 6 C218621 ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information The title of section 9.3 of the ICH M11 protocol guideline: Pregnancy and Postpartum Information. 6 C218622 ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial The title of section 9.3.1 of the ICH M11 protocol guideline: Participants Who Become Pregnant During the Trial. 6 C218623 ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial The title of section 9.3.2 of the ICH M11 protocol guideline: Participants Whose Partners Become Pregnant During the Trial. 6 C218624 ICH M11 Protocol Section 9.4 Special Safety Situations The title of section 9.4 of the ICH M11 protocol guideline: Special Safety Situations. 6 C222770 ICH M11 Protocol Section Amendment Details The title of the amendment details section of the ICH M11 protocol guideline: Amendment Details. 6 C222769 ICH M11 Protocol Section Title Page Title Page Section of the ICH M11 Protocol standard, Title Page.
HL7 International / Biomedical Research and Regulation
This is a fragment from the NCI Thesaurus covering codes used by ICH M11 Value Sets. These should all be moved into tx.fhir.org but are included here in FHIR format for testing and validation.
Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license For more licensing information and links see: [licenses.html](licenses.html)
A distinguishing quality or prominent aspect of a person, object, action, process, or substance.
Knowledge derived from study, experience, or instruction that has been gathered or received by communication.
Information regarding the means of contacting a person or group.
Designated Medical Expert Contact Information
The contact information for the sponsor's representative who can advise on specific trial-related medical questions or problems.
A symbol or combination of symbols which is assigned to the members of a collection.
An alphanumeric system designed to identify countries. The ISO 3166 standard includes a two letter representation, a three letter representation, and a 3 number representation. The last two are identical to the UN system. The US State Department system maintains a separate two letter representation code set.
The two-letter country codes specified by the ISO 3166-1 country code standard.
The three-letter country codes specified by the ISO 3166-1 country code standard.
The numeric, three-digit country codes specified by the ISO 3166-1 country code standard.
A term that helps define and render a concept unique.
Terms used to indicate units of time or other terms associated with time.
The particular day, month and year an event has happened or will happen.
A date of an official approbation, recognition, or acceptance as satisfactory.
The date that the sponsor approved a version of the protocol.
The date (and time) on which an entity is versioned.
The date on which the document is versioned.
A term that helps define and render another concept unique.
Not known, observed, recorded; or reported as unknown by the data contributor.
It is unknown whether any transformation of the product takes place.
A specific reason explaining why a meaningful value is not available. A meaningful value answers the question posed by a Data Element Concept. In contrast, a Missing Value Reason answers the implicit question "Why is there no 'meaningful' value?", when there is none.
Determination of a value is not relevant in the current context.
Different than the one(s) previously specified or mentioned.
Covering or affecting the whole of a system.
Covering or affecting only a portion of the entire system.
Covering or affecting a cohort of individuals.
An adjectival term used to specify a region of the body or other concepts associated with the body.
A position, site, or point in space where something can be found.
Location of Medical Expert Contact Information
The physical or virtual location of the medical expert (as designated by the sponsor) contact information.
The physical or virtual location of the date on which the sponsor approved the current version of the protocol.
Location of Sponsor Signatory Information
The physical or virtual location of the sponsor signatory information.
An active process; excludes processes and mechanisms which fulfill biological functions.
The actions or reactions of an object or organism, usually in relation to the environment or surrounding world of stimuli.
The exchange of information between objects, people, or groups.
A statement (either spoken or written) that is made in reply to a question, request, criticism, or accusation.
A statement (either spoken or written) that is made in reply to a question or request or criticism or accusation; a statement that solves a problem or explains how to solve the problem.
The non-affirmative response to a question.
Consent by a patient to a surgical or medical procedure or participation in a clinical study after achieving an understanding of the relevant medical facts and the risks involved.
Any specific activity undertaken during the course of a clinical study or research protocol.
Systematic investigation into a subject in order to discover facts, establish or revise a theory, or develop a plan of action based on the facts discovered.
A detailed examination, analysis, or critical inspection of a subject designed to discover facts about it.
Research conducted with human subjects or on material of human origin in which an investigator directly interacts with human subjects; includes development of new technologies, study of mechanisms of human diseases, therapy, clinical trials, epidemiologic, behavior, and health services research.
A clinical study classified by its type, such as observational studies, case-control studies, cohort studies, cross-sectional studies, and clinical trials.
A research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
A description of a clinical trial by the phase of the trial (I, II, III, or IV).
Exploratory clinical trials, in a small number of participants, that are conducted early in Phase 1. The investigational trial intervention is administered at a low dose for a limited time. Early Phase 1 trials provide insights into a variety of parameters such as pharmacokinetic, pharmacodynamic, and other biomarkers. They involve limited human exposure, have no therapeutic or diagnostic intent, and are not intended to assess clinical tolerability.
Exploratory clinical trials that may be first-in-human, conducted in a small number of patients or healthy volunteers to evaluate clinical safety, tolerability, or therapeutic intent (pharmacokinetics and pharmacodynamics) of an investigational trial intervention.
A type of phase 1 clinical trial in which the test product is administered to human beings for the first time.
A type of phase 1 trial with a single ascending dose (dose escalation) in a small group of patients (in comparison to a Phase 1b).
A type of phase 1 trial with multiple ascending doses (dose expansion) in a larger group of patients (in comparison to a Phase 1a).
A single clinical trial that combines elements of Phase 1 and Phase 2 trials, which may begin as a Phase 1 trial and transition into Phase 2 based upon predetermined criteria.
Select candidate vaccines or concepts suitable for Phase I and Phase II trials and conduct these trials.
A study that begins as a Phase I study and transitions into Phases II and III based upon successful completion of each previous portion.
A study that begins as a Phase I study and transitions into a Phase III study upon successful completion of the Phase I portion.
Exploratory trials conducted to evaluate the safety and efficacy of the investigational trial intervention in patients with the disease or condition. Objectives may include, but are not limited to, clinical pharmacology, dose-ranging (dose-response, frequency of dosing), type of patients, or other characteristics of safety and efficacy.
A clinical research protocol generally referred to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question.
A clinical research protocol generally referred to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.
A type of clinical study that combines elements characteristic of traditional Phase II and Phase III trials.
A study that begins as a Phase II study and transitions into Phases III and IV based upon successful completion of each previous portion.
Confirmatory trials conducted to demonstrate safety, efficacy and tolerability of the investigational trial intervention in patients with the disease or condition. Their objectives are to evaluate the overall benefit-risk relationship and may provide substantial evidence for regulatory approval and product information.
Select suitable vaccine candidates and support efficacy trials when appropriate criteria are met.
A classification typically assigned retrospectively to a Phase III trial after regulatory authorities determined the need for a Phase III B trial.
A type of Phase III trial executed near the time of approval to elicit additional findings. This type of trial may be required as a condition of regulatory authority approval.
A type of clinical study that combines elements characteristic of traditional Phase III and Phase IV trials.
Post-approval (or post-marketing) trials conducted to further evaluate the safety and efficacy of an investigational trial intervention in its approved indication and may be conducted to address a regulatory requirement. These studies may explore use of the investigational trial intervention in the real-world setting of clinical practice and may also inform health economics and health technology assessments.
A practiced and regimented skill or series of actions.
Technique used in the laboratory for scientific research.
A qualitative or quantitative analysis performed to determine the amount of a particular constituent in a sample or the biological or pharmacological properties or activity of a drug or substance.
Assay conducted in an artificial environment, such as in a test tube, under a defined and controlled set of solvent and solute conditions.
An immunoassay to detect Tumor Necrosis Factor (TNF), which is a potent lymphoid factor, and exerts cytotoxic effects on a wide range of tumor cells and other target cells. Utilizes monoclonal antibody to TNF immobilized on microtitre plate.
An organizational header for concepts representing mostly abstract entities.
A grouping of occupations and fields of study.
The principal activity that a person does to earn money.
A person, enterprise, or entity that produces finished goods.
A person or entity that designs, manufactures, fabricates, assembles, or processes a finished device.
A verbal and/or written message that asserts, affirms, or declares something.
Protocol Previously Amended See Summary of Changes Before the Table of Contents
This protocol has been amended previously. The Protocol Amendment Summary of Changes for the current amendment is located directly before the Table of Contents. Prior amendment(s) to this protocol are listed in the table below, beginning with the most recent.
Protocol Previously Amended, Details Presented
This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s).
An event, entity or condition that typically characterizes a prescribed environment or situation and determines or aids in determining whether certain stated circumstances exist or criteria are satisfied.
Amendment Scope Global Applicability Indicator
A descriptive indicator of whether the amendment scope applies globally across the trial.
An indication as to whether the protocol document reflects the original version of the protocol.
A distinguishable part, a stage in a series of events or in a process of development, e.g. any of the varying aspects or stages in course of a disease; a fraction of a cycle.
Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment for safety in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people to measure whether the treatment actually benefits patients, and whether its benefits exceed its risks; and Phase IV takes place after the drug or treatment has been licensed and marketed.
An explanation of the cause of some phenomenon or action.
The rationale for the change(s) to, or formal clarification of, a protocol.
Change in Standard Of Care Amendment Reason
A change in the standard of care necessitates a change(s) to, or formal clarification of, the protocol.
A change in the study purpose or intent of the scientific plan necessitates a change(s) to, or formal clarification of, the protocol.
The addition of an investigational medicinal product to a clinical trial design necessitates a change(s) to, or formal clarification of, the protocol.
Inconsistency and/or Error in the Protocol Amendment Reason
An error or inconsistency in the protocol necessitates a change(s) to, or formal clarification of, the protocol.
Investigator/Site Feedback Amendment Reason
Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol.
Feedback from the institutional review board or independent ethics committee necessitates a change(s) to, or formal clarification of, the protocol.
A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol.
New Data Available (Other Than Safety Data) Amendment Reason
Previously unavailable data (other than safety data) becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.
New Regulatory Guidance Amendment Reason
A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol.
New Safety Information Available Amendment Reason
Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.
A protocol design error necessitates a change(s) to, or formal clarification of, a document.
Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol.
Regulatory Agency Request to Amend Amendment Reason
A regulatory agency has expressed a need for a change(s) to, or formal clarification of, the protocol.
An individual who is classified by their work type.
The primary person in charge of the care of a patient, usually a family member or a designated health care professional.
Different from the previously specified or mentioned type of person who has primary responsibility for the assistance and supervision for an individual.
A person described by an activity with which they are engaged.
A person or organization that supports or champions something.
The party who submits a marketing application to FDA for approval of a drug, device, or biologic product. An applicant is the person or entity who assumes responsibility for the marketing of a new medical product, including responsibility for compliance with applicable provisions of the Federal Food, Drug, and Cosmetic Act and related regulations. The sponsor is usually an individual, partnership, corporation, government agency, manufacturer or scientific institution.
Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on sponsorship responsibilities. (WHO)
A sponsor that initiates the investigation and is legally responsible for the study.
An individual, company, institution, or organization that is designated by the study sponsor as a vested partner in the study.
The sponsor's legal representative at a geographical region within which the sponsor has no legal presence. (ICH M11)
An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary)
A person or organization that takes responsibility for a trial which is part of the development program for a marketing authorization of a medicinal product at the time of the application. (EUDRACT)
A person or organization that takes responsibility for a trial that is not part of the development program for a marketing authorization of a medicinal product at the time of the application. (EUDRACT)
The individual, organization, group or other legal person taking responsibility for securing the arrangements to initiate and/or manage a study (including arrangements to ensure that the study design meets appropriate standards and to ensure appropriate conduct and reporting). In commercial trials, the primary sponsor is normally the main applicant for regulatory authorization to begin the study. It may or may not be the main funder.
Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship. A secondary sponsor may have agreed -to take on all the responsibilities of sponsorship jointly with the primary sponsor; or to form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group; or to act as the sponsor's legal representative in relation to some or all of the study sites; or to take responsibility for the accuracy of study registration information submitted.
Any number of entities (members) considered as a unit.
A group of individuals united by a common factor (e.g., geographic location, ethnicity, disease, age, sex).
A physician or health care provider selected by the sponsor to be readily available to advise clinical trial officials on trial related medical questions or problems.
A person who determines the significance, worth, or condition of something by careful appraisal and study.
The individual who evaluates the outcome(s) of interest.
An individual who conducts scientific research. In a clinical setting this individual actually conducts and/or supervises the clinical investigation and study-related procedures. The investigator monitors the safety of the trial subjects and investigational staff (under whose immediate direction an agent is administered or dispensed to a subject). The investigator collects and analyses data and study documents, and provides reports in compliance with applicable requirements.
The characteristic that defines the responsibility of the investigator on a particular study.
One of two or more scientists working together on a research project. A person that equally contributes to the preparation of the protocol, and shares the responsibilities of this position, including medical monitoring (particularly toxicity/safety), liaison with statisticians over analysis, and the generation of a report containing the results.
A research scientist whose task is to see that work, or events, goes harmoniously.
In the case of a multinational study, a person who has the responsibilities of the sponsor of the study in his/her country and will be responsible for the coordination of the principal investigators at different sites within that member state. (EMA)
An individual designated by the grantee to take part in the conduction of the study or to participate in a scientific activity being supported by the grant.
An investigator who is responsible for all aspects of the conduct of a study.
A scientist or health care professional that has a financial agreement, as outlined in a binding statement of work, with the sponsor to bear full and ultimate responsibility for the scientific, administrative, ethical, legal, technical, and fiscal aspects of the study, and for day-to-day management of the scientific project, as well as for documenting and reporting its results.
The investigator named on the award document. This investigator has full and ultimate responsibility for all research conducted under the award.
An individual designated by the grantee to direct the project or activity being supported by the grant. He or she is responsible for the scientific, legal, administrative, and technical aspects of the grant and accountable to the grantee for the proper conduct of the project or activity. The Principle Investigator (PI) must have a formal written appointment with the applicant organization, which must be in the form of an official relationship between the parties, but need not involve a salary or other form of remuneration. The PI is a member of the grantee team responsible for ensuring compliance with the financial and administrative aspects of the award and with organizational as well as Federal requirements.
Primary clinical researcher of a clinical trial, ultimately responsible for all aspects in the conduct of a study, but has special responsibility with regard to the implementation and administration of the study design, and methodology of a trial.
The investigator who officially represents a clinical site that participates in a multicentral clinical trial. The responsibilities of the official include the management of site compliance with rules and regulations and attention to personnel and patient requisites.
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).
A researcher who does not have a degree in medicine.
A researcher at a study site who oversees multiple aspects of the study at a site, including protocol submission for IRB approval, participant recruitment, informed consent, data collection, and analysis.
The study investigator in charge of administering treatment to study participants.
Some matter, situation, or event that is thought about, written about, or discussed.
An entity, either biologic or otherwise, of interest in an investigation.
A matter or an individual that is observed, analyzed, examined, investigated, experimented upon, or/and treated in the course of a particular study.
Any individiual that has a role in a study, including study personnel and study subjects.
A participant in a study that presents a greater than moderate risk due to the increased probability for generating serious adverse events. Since there is a probability of an event that is serious and prolonged or permanent occurring as a result of study participation, the participant will require high intensity monitoring.
Anything (e.g., a document) providing permanent evidence of or information about past events.
A physical object, or electronic counterpart, that is characterized by containing writing which is meant to be human-readable.
A rule which guides how an activity should be performed.
A component of a plan on which a study is based.
A written message providing an official assurance, account, or assertion within the study protocol.
A written message within the study protocol that asserts a statement of non-disclosure, such that information contained within the protocol document may only be shared with authorized parties.
Individual's name or personal mark, used to sign documents and employed to signify that the writing which precedes accords with one's wishes and intentions; having a handwritten signature.
A block of text containing the name and signature of the sponsor's signatory, along with the signature date.
One or more characters used to identify, name, or characterize the nature, properties, or contents of a thing.
A sequence of characters used to identify, name, or characterize the study site.
A sequence of characters used to identify and/or name the region.
Other Regulatory or Clinical Trial Identifier
A sequence of characters assigned by a regulatory agency or other health authority that is used to identify a clinical trial, and that is different than the one(s) previously specified or mentioned.
A symbol or combination of symbols that are assigned by the sponsor to uniquely identify an experimental intervention.
A set of characters used as a code that is unique in the context or the system for which it is created. It serves as a means of identification and reference (often instead of a name) for an entity, person, thing, function, procedure, activity, variable, or body of data.
A sequence of letters, numbers, or other characters that uniquely identifies a clinical trial within a clinical trial registry.
The unique alphanumeric identifier for a trial as assigned by the Clinicaltrials.gov Protocol Registration and Results System (PRS).
Clinicaltrials.gov NCT Number for the Expanded Access Record
The unique alphanumeric identifier for a study with associated expanded access record, as assigned by the clinicaltrials.gov PRS system.
A sequence of letters, numbers, or other characters that uniquely identifies a study protocol.
A unique code, which is assigned by the sponsor, that identifies a specific protocol.
A sequence of characters used to identify a clinical trial, as assigned by the World Health organization's International Clinical Trial's Registry Platform (ICTRP).
A sequence of characters used to uniquely identify a protocol amendment.
A sequence of characters used to identify a clinical trial under an Investigational New Drug (IND) application, as assigned by the Chinese National Medicinal Products Administration (NMPA).
US FDA Investigational Device Exemption Application Number
A sequence of characters used to identify a clinical trial under an Investigational Device Exemption (IDE) application, as assigned by the US Food and Drug Administration.
A sequence of characters used to identify a clinical trial, as assigned by the Clinical Trials Information System (CTIS) of the European Medicines Agency.
Japan Registry for Clinical Trials Number
A sequence of characters used to identify a clinical trial, as assigned by the Japan Registry for Clinical Trials (JRCT) of the Ministry of Health, Labour and Welfare (MHLW) in Japan.
US FDA Investigational New Drug Application Number
A sequence of characters used to identify a clinical trial under an Investigational New Drug (IND) application, as assigned by the US Food and Drug Administration.
A textual representation of the narrative content.
A numeric character string that identifies a form or variant of a type or original.
A string of numerals that uniquely identifies a specific version of a study protocol.
A standardized representation of the location of a person, business, building, or organization.
A physical location used by a person or organization for the purpose of receiving postal mail deliveries.
A contact point used to send physical forms of communication to the healthcare provider.
A contact point used to send physical forms of communication to the healthcare facility.
A contact point used to send physical forms of communication to the organization.
A contact point used to send physical forms of communication to the organizational contact.
A contact point used to send physical forms of communication to the performer.
A contact point used to send physical forms of communication to the person.
A contact point used to send physical forms of communication to the research staff.
Service Delivery Location Postal Address
The postal address of the service delivery location.
A physical location used by a study contact for the purpose of receiving postal mail deliveries.
A contact point used to send physical forms of communication to the study personnel.
A contact point used to send physical forms of communication to the study site personnel.
The legally registered address of the trial sponsor.
The legally registered address of the trial co-sponsor.
The legally registered address of the device manufacturer.
The legally registered address of the sponsor's legal representative at a geographical region within which the sponsor has no legal presence.
Particulars considered individually and in relation to a whole.
Particulars about the protocol amendment, considered individually and in relation to a whole.
The words or language units by which a thing is known.
The literal identifier (i.e., distinctive designation) of the trial co-sponsor.
The literal identifier (i.e., distinctive designation) of the organization defined as being responsible for creating the device as stated on the package in which the product is supplied.
The literal identifier (i.e., distinctive designation) of the sponsor's legal representative at a geographical region within which the sponsor has no legal presence.
The literal identifier (i.e., distinctive designation) of the trial sponsor.
An official descriptive name of a document, e.g. the long name of a study protocol provided by the study sponsor.
The formal, descriptive name of the protocol.
The title of the document intended for the general population.
Study Protocol Document Version Public Title
The short descriptive name for the trial.
The short descriptive name for the study.
A more extensive descriptive name of the study that is intended for medical professionals, written using medical and scientific language.
The formal descriptive name for the study.
The descriptive name of the study that is intended for the lay public, written in easily understood language.
The non-unique initials or abbreviated name used for identification.
The non-unique initials or abbreviated name used for identification of the study protocol document version.
The non-unique initials or abbreviated name used for identification of the study.
The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.
Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name.
A name within a pharmaceutical compendium that designates a small or large molecule substance that complies with compendial standards for strength, quality, and purity. (USP Nomenclature Guidelines)
A unique, internationally consistent and globally recognized name which identifies pharmaceutical substances or active pharmaceutical ingredients and is public property.
A unique nonproprietary name assigned to drugs and biologics by the United States Adopted Names Council (USAN).
A unique nonproprietary name assigned to drugs and biologics by the United States Pharmacopeia (USP) or excipients by the National Formulary (NF).
Document Content Reference Section Title
An identifying designation for a particular section for the document content reference.
An identifying designation for a section within a protocol document.
An identifying designation for a section within the ICH M11 protocol template document.
ICH M11 Protocol Section 1 PROTOCOL SUMMARY
The title of section 1 of the ICH M11 protocol guideline: PROTOCOL SUMMARY.
ICH M11 Protocol Section 1.1 Protocol Synopsis
The title of section 1.1 of the ICH M11 protocol guideline: Protocol Synopsis.
ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and Estimands
The title of section 1.1.1 of the ICH M11 protocol guideline: Primary and Secondary Objectives and Estimands.
ICH M11 Protocol Section 1.1.2 Overall Design
The title of section 1.1.2 of the ICH M11 protocol guideline: Overall Design.
ICH M11 Protocol Section 1.2 Trial Schema
The title of section 1.2 of the ICH M11 protocol guideline: Trial Schema.
ICH M11 Protocol Section 1.3 Schedule of Activities
The title of section 1.3 of the ICH M11 protocol guideline: Schedule of Activities.
ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS
The title of section 10 of the ICH M11 protocol guideline: STATISTICAL CONSIDERATIONS.
ICH M11 Protocol Section 10.1 General Considerations
The title of section 10.1 of the ICH M11 protocol guideline: General Considerations.
ICH M11 Protocol Section 10.10 Multiplicity Adjustments
The title of section 10.10 of the ICH M11 protocol guideline: Multiplicity Adjustments.
ICH M11 Protocol Section 10.11 Sample Size Determination
The title of section 10.11 of the ICH M11 protocol guideline: Sample Size Determination.
ICH M11 Protocol Section 10.2 Analysis Sets
The title of section 10.2 of the ICH M11 protocol guideline: Analysis Sets.
ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables
The title of section 10.3 of the ICH M11 protocol guideline: Analyses of Demographics and Other Baseline Variables.
ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s)
The title of section 10.4 of the ICH M11 protocol guideline: Analyses Associated with the Primary Objective(s).
ICH M11 Protocol Section 10.4.1 Primary Objective
The title of section 10.4.1 of the ICH M11 protocol guideline: Primary Objective.
ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method
The title of section 10.4.1.1 of the ICH M11 protocol guideline: Statistical Analysis Method.
ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)
The title of section 10.4.1.2 of the ICH M11 protocol guideline: Handling of Data in Relation to Primary Estimand(s).
ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)
The title of section 10.4.1.3 of the ICH M11 protocol guideline: Handling of Missing Data in Relation to Primary Estimand(s)
ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis
The title of section 10.4.1.4 of the ICH M11 protocol guideline: Sensitivity Analysis.
ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis
The title of section 10.4.1.5 of the ICH M11 protocol guideline: Supplementary Analysis.
ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)
The title of section 10.5 of the ICH M11 protocol guideline: Analyses Associated with the Secondary Objective(s).
ICH M11 Protocol Section 10.5.1 Secondary Objective
The title of section 10.5.1 of the ICH M11 protocol guideline: Secondary Objective.
ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method
The title of section 10.5.1.1 of the ICH M11 protocol guideline: Statistical Analysis Method.
ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)
The title of section 10.5.1.2 of the ICH M11 protocol guideline: Handling of Data in Relation to Secondary Estimand(s).
ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)
The title of section 10.5.1.3 of the ICH M11 protocol guideline: Handling of Missing Data in Relation to Secondary Estimand(s).
ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis
The title of section 10.5.1.4 of the ICH M11 protocol guideline: Sensitivity Analysis.
ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis
The title of section 10.5.1.5 of the ICH M11 protocol guideline: Supplementary Analysis.
ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)
The title of section 10.6 of the ICH M11 protocol guideline: Analyses Associated with the Exploratory Objective(s).
ICH M11 Protocol Section 10.7 Safety Analyses
The title of section 10.7 of the ICH M11 protocol guideline: Safety Analyses.
ICH M11 Protocol Section 10.8 Other Analyses
The title of section 10.8 of the ICH M11 protocol guideline: Other Analyses.
ICH M11 Protocol Section 10.9 Interim Analyses
The title of section 10.9 of the ICH M11 protocol guideline: Interim Analyses.
ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
The title of section 11 of the ICH M11 protocol guideline: TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS.
ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations
The title of section 11.1 of the ICH M11 protocol guideline: Regulatory and Ethical Considerations.
ICH M11 Protocol Section 11.10 Protocol Deviations
The title of section 11.10 of the ICH M11 protocol guideline: Protocol Deviations.
ICH M11 Protocol Section 11.11 Early Site Closure
The title of section 11.11 of the ICH M11 protocol guideline: Early Site Closure.
ICH M11 Protocol Section 11.12 Data Dissemination
The title of section 11.12 of the ICH M11 protocol guideline: Data Dissemination.
ICH M11 Protocol Section 11.2 Trial Oversight
The title of section 11.2 of the ICH M11 protocol guideline: Trial Oversight.
ICH M11 Protocol Section 11.2.1 Investigator Responsibilities
The title of section 11.2.1 of the ICH M11 protocol guideline: Investigator Responsibilities.
ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities
The title of section 11.2.2 of the ICH M11 protocol guideline: Sponsor Responsibilities.
ICH M11 Protocol Section 11.3 Informed Consent Process
The title of section 11.3 of the ICH M11 protocol guideline: Informed Consent Process.
ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening
The title of section 11.3.1 of the ICH M11 protocol guideline: Informed Consent for Rescreening.
ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research
The title of section 11.3.2 of the ICH M11 protocol guideline: Informed Consent for Use of Remaining Samples in Exploratory Research.
ICH M11 Protocol Section 11.4 Committees
The title of section 11.4 of the ICH M11 protocol guideline: Committees.
ICH M11 Protocol Section 11.5 Insurance and Indemnity
The title of section 11.5 of the ICH M11 protocol guideline: Insurance and Indemnity.
ICH M11 Protocol Section 11.6 Risk-Based Quality Management
The title of section 11.6 of the ICH M11 protocol guideline: Risk-Based Quality Management.
ICH M11 Protocol Section 11.7 Data Governance
The title of section 11.7 of the ICH M11 protocol guideline: Data Governance.
ICH M11 Protocol Section 11.8 Data Protection
The title of section 11.8 of the ICH M11 protocol guideline: Data Protection.
ICH M11 Protocol Section 11.9 Source Records
The title of section 11.9 of the ICH M11 protocol guideline: Source Records.
ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS
The title of section 12 of the ICH M11 protocol guideline: APPENDIX: SUPPORTING DETAILS.
ICH M11 Protocol Section 12.1 Clinical Laboratory Tests
The title of section 12.1 of the ICH M11 protocol guideline: Clinical Laboratory Tests.
ICH M11 Protocol Section 12.2 Country/Region-Specific Differences
The title of section 12.2 of the ICH M11 protocol guideline: Country/Region-Specific Differences.
ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)
The title of section 12.3 of the ICH M11 protocol guideline: Prior Protocol Amendment(s).
ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS
The title of section 13 of the ICH M11 protocol guideline: APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS.
ICH M11 Protocol Section 14 APPENDIX: REFERENCES
The title of section 14 of the ICH M11 protocol guideline: APPENDIX: REFERENCES.
The title of section 2 of the ICH M11 protocol guideline: INTRODUCTION.
ICH M11 Protocol Section 2.1 Purpose of Trial
The title of section 2.1 of the ICH M11 protocol guideline: Purpose of Trial.
ICH M11 Protocol Section 2.2 Assessment of Risks and Benefits
The title of section 2.2 of the ICH M11 protocol guideline: Assessment of Risks and Benefits.
ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation Strategy
The title of section 2.2.2 of the ICH M11 protocol guideline: Risk Summary and Mitigation Strategy.
ICH M11 Protocol Section 2.2.2 Benefit Summary
The title of section 2.2.1 of the ICH M11 protocol guideline: Benefit Summary.
ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit Assessment
The title of section 2.2.3 of the ICH M11 protocol guideline: Overall Risk-Benefit Assessment.
ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS
The title of section 3 of the ICH M11 protocol guideline: TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS.
ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s)
The title of section 3.1 of the ICH M11 protocol guideline: Primary Objective(s) and Associated Estimand(s).
ICH M11 Protocol Section 3.1.1 Primary Objective
The title of section 3.1.1 of the ICH M11 protocol guideline: Primary Objective.
ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)
The title of section 3.2 of the ICH M11 protocol guideline: Secondary Objective(s) and Associated Estimand(s).
ICH M11 Protocol Section 3.2.1 Secondary Objective
The title of section 3.2.1 of the ICH M11 protocol guideline: Secondary Objective.
ICH M11 Protocol Section 3.3 Exploratory Objective(s)
The title of section 3.3 of the ICH M11 protocol guideline: Exploratory Objective(s).
ICH M11 Protocol Section 3.3.1 Exploratory Objective
The title of section 3.3.1 of the ICH M11 protocol guideline: Exploratory Objective.
The title of section 4 of the ICH M11 protocol guideline: TRIAL DESIGN.
ICH M11 Protocol Section 4.1 Description of Trial Design
The title of section 4.1 of the ICH M11 protocol guideline: Description of Trial Design.
ICH M11 Protocol Section 4.1.1 Stakeholder Input into Design
The title of section 4.1.1 of the ICH M11 protocol guideline: Stakeholder Input into Design.
ICH M11 Protocol Section 4.2 Rationale for Trial Design
The title of section 4.2 of the ICH M11 protocol guideline: Rationale for Trial Design.
ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s)
The title of section 4.2.1 of the ICH M11 protocol guideline: Rationale for Estimand(s).
ICH M11 Protocol Section 4.2.2 Rationale for Intervention Model
The title of section 4.2.2 of the ICH M11 protocol guideline: Rationale for Intervention Model.
ICH M11 Protocol Section 4.2.3 Rationale for Control Type
The title of section 4.2.3 of the ICH M11 protocol guideline: Rationale for Control Type.
ICH M11 Protocol Section 4.2.4 Rationale for Trial Duration
The title of section 4.2.4 of the ICH M11 protocol guideline: Rationale for Trial Duration.
ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design
The title of section 4.2.5 of the ICH M11 protocol guideline: Rationale for Adaptive or Novel Trial Design.
ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis
The title of section 4.2.6 of the ICH M11 protocol guideline: Rationale for Interim Analysis.
ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design Aspects
The title of section 4.2.7 of the ICH M11 protocol guideline: Rationale for Other Trial Design Aspects.
ICH M11 Protocol Section 4.3 Trial Stopping Rules
The title of section 4.3 of the ICH M11 protocol guideline: Trial Stopping Rules.
ICH M11 Protocol Section 4.4 Start of Trial and End of Trial
The title of section 4.4 of the ICH M11 protocol guideline: Start of Trial and End of Trial.
ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of Trial
The title of section 4.5 of the ICH M11 protocol guideline: Access to Trial Intervention After End of Trial.
ICH M11 Protocol Section 5 TRIAL POPULATION
The title of section 5 of the ICH M11 protocol guideline: TRIAL POPULATION.
ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale
The title of section 5.1 of the ICH M11 protocol guideline: Description of Trial Population and Rationale.
ICH M11 Protocol Section 5.2 Inclusion Criteria
The title of section 5.2 of the ICH M11 protocol guideline: Inclusion Criteria.
ICH M11 Protocol Section 5.3 Exclusion Criteria
The title of section 5.3 of the ICH M11 protocol guideline: Exclusion Criteria.
ICH M11 Protocol Section 5.4 Contraception
The title of section 5.4 of the ICH M11 protocol guideline: Contraception.
ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential
The title of section 5.4.1 of the ICH M11 protocol guideline: Definitions Related to Childbearing Potential.
ICH M11 Protocol Section 5.4.2 Contraception Requirements
The title of section 5.4.2 of the ICH M11 protocol guideline: Contraception Requirements.
ICH M11 Protocol Section 5.5 Lifestyle Restrictions
The title of section 5.5 of the ICH M11 protocol guideline: Lifestyle Restrictions.
ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions
The title of section 5.5.1 of the ICH M11 protocol guideline: Meals and Dietary Restrictions.
ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions
The title of section 5.5.2 of the ICH M11 protocol guideline: Caffeine, Alcohol, Tobacco, and Other Restrictions.
ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions
The title of section 5.5.3 of the ICH M11 protocol guideline: Physical Activity Restrictions.
ICH M11 Protocol Section 5.5.4 Other Activity Restrictions
The title of section 5.5.4 of the ICH M11 protocol guideline: Other Activity Restrictions.
ICH M11 Protocol Section 5.6 Screen Failure and Rescreening
The title of section 5.6 of the ICH M11 protocol guideline: Screen Failure and Rescreening.
ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY
The title of section 6 of the ICH M11 protocol guideline: TRIAL INTERVENTION AND CONCOMITANT THERAPY.
ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention
The title of section 6.1 of the ICH M11 protocol guideline: Description of Investigational Trial Intervention.
ICH M11 Protocol Section 6.10 Concomitant Therapy
The title of section 6.10 of the ICH M11 protocol guideline: Concomitant Therapy.
ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy
The title of section 6.10.1 of the ICH M11 protocol guideline: Prohibited Concomitant Therapy.
ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy
The title of section 6.10.2 of the ICH M11 protocol guideline: Permitted Concomitant Therapy.
ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen
The title of section 6.2 of the ICH M11 protocol guideline: Rationale for Investigational Trial Intervention Dose and Regimen.
ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration
The title of section 6.3 of the ICH M11 protocol guideline: Investigational Trial Intervention Administration.
ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification
The title of section 6.4 of the ICH M11 protocol guideline: Investigational Trial Intervention Dose Modification.
ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose
The title of section 6.5 of the ICH M11 protocol guideline: Management of Investigational Trial Intervention Overdose.
ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
The title of section 6.6 of the ICH M11 protocol guideline: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention.
ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention
The title of section 6.6.1 of the ICH M11 protocol guideline: Preparation of Investigational Trial Intervention.
ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention
The title of section 6.6.2 of the ICH M11 protocol guideline: Storage and Handling of Investigational Trial Intervention.
ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention
The title of section 6.6.3 of the ICH M11 protocol guideline: Accountability of Investigational Trial Intervention.
ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding
The title of section 6.7 of the ICH M11 protocol guideline: Investigational Trial Intervention Assignment, Randomisation and Blinding.
ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention
The title of section 6.7.1 of the ICH M11 protocol guideline: Participant Assignment to Investigational Trial Intervention.
ICH M11 Protocol Section 6.7.2 Randomisation
The title of section 6.7.2 of the ICH M11 protocol guideline: Randomisation.
ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding
The title of section 6.7.3 of the ICH M11 protocol guideline: Measures to Maintain Blinding.
ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site
The title of section 6.7.4 of the ICH M11 protocol guideline: Emergency Unblinding at the Site.
ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence
The title of section 6.8 of the ICH M11 protocol guideline: Investigational Trial Intervention Adherence.
ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention
The title of section 6.9 of the ICH M11 protocol guideline: Description of Noninvestigational Trial Intervention.
ICH M11 Protocol Section 6.9.1 Background Trial Intervention
The title of section 6.9.1 of the ICH M11 protocol guideline: Background Trial Intervention.
ICH M11 Protocol Section 6.9.2 Rescue Therapy
The title of section 6.9.2 of the ICH M11 protocol guideline: Rescue Therapy.
ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention
The title of section 6.9.3 of the ICH M11 protocol guideline: Other Noninvestigational Trial Intervention.
ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL
The title of section 7 of the ICH M11 protocol guideline: PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL.
ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants
The title of section 7.1 of the ICH M11 protocol guideline: Discontinuation of Trial Intervention for Individual Participants.
ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention
The title of section 7.1.1 of the ICH M11 protocol guideline: Permanent Discontinuation of Trial Intervention.
ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention
The title of section 7.1.2 of the ICH M11 protocol guideline: Temporary Discontinuation of Trial Intervention.
ICH M11 Protocol Section 7.1.3 Rechallenge
The title of section 7.1.3 of the ICH M11 protocol guideline: Rechallenge.
ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial
The title of section 7.2 of the ICH M11 protocol guideline: Participant Discontinuation or Withdrawal from the Trial.
ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up
The title of section 7.3 of the ICH M11 protocol guideline: Management of Loss to Follow-Up.
ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
The title of section 8 of the ICH M11 protocol guideline: TRIAL ASSESSMENTS AND PROCEDURES.
ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations
The title of section 8.1 of the ICH M11 protocol guideline: Trial Assessments and Procedures Considerations.
ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures
The title of section 8.2 of the ICH M11 protocol guideline: Screening/Baseline Assessments and Procedures.
ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures
The title of section 8.3 of the ICH M11 protocol guideline: Efficacy Assessments and Procedures.
ICH M11 Protocol Section 8.4 Safety Assessments and Procedures
The title of section 8.4 of the ICH M11 protocol guideline: Safety Assessments and Procedures.
ICH M11 Protocol Section 8.4.1 Physical Examination
The title of section 8.4.1 of the ICH M11 protocol guideline: Physical Examination.
ICH M11 Protocol Section 8.4.2 Vital Signs
The title of section 8.4.2 of the ICH M11 protocol guideline: Vital Signs.
ICH M11 Protocol Section 8.4.3 Electrocardiograms
The title of section 8.4.3 of the ICH M11 protocol guideline: Electrocardiograms.
ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments
The title of section 8.4.4 of the ICH M11 protocol guideline: Clinical Laboratory Assessments.
ICH M11 Protocol Section 8.4.5 Pregnancy Testing
The title of section 8.4.5 of the ICH M11 protocol guideline: Pregnancy Testing.
ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring
The title of section 8.4.6 of the ICH M11 protocol guideline: Suicidal Ideation and Behaviour Risk Monitoring.
ICH M11 Protocol Section 8.5 Pharmacokinetics
The title of section 8.5 of the ICH M11 protocol guideline: Pharmacokinetics.
The title of section 8.6 of the ICH M11 protocol guideline: Biomarkers.
ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics
The title of section 8.6.1 of the ICH M11 protocol guideline: Genetics, Genomics, Pharmacogenetics and Pharmacogenomics.
ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers
The title of section 8.6.2 of the ICH M11 protocol guideline: Pharmacodynamic Biomarkers.
ICH M11 Protocol Section 8.6.3 Other Biomarkers
The title of section 8.6.3 of the ICH M11 protocol guideline: Other Biomarkers.
ICH M11 Protocol Section 8.7 Immunogenicity Assessments
The title of section 8.7 of the ICH M11 protocol guideline: Immunogenicity Assessments.
ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics
The title of section 8.8 of the ICH M11 protocol guideline: Medical Resource Utilisation and Health Economics.
ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
The title of section 9 of the ICH M11 protocol guideline: ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS.
ICH M11 Protocol Section 9.1 Definitions
The title of section 9.1 of the ICH M11 protocol guideline: Definitions.
ICH M11 Protocol Section 9.1.1 Definitions of Adverse Events
The title of section 9.1.1 of the ICH M11 protocol guideline: Definitions of Adverse Events.
ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse Events
The title of section 9.1.2 of the ICH M11 protocol guideline: Definitions of Serious Adverse Events.
ICH M11 Protocol Section 9.1.3 Definitions of Product Complaints
The title of section 9.1.3 of the ICH M11 protocol guideline: Definitions of Product Complaints.
ICH M11 Protocol Section 9.1.3.1 Definitions of Medical Device Product Complaints
The title of section 9.1.3.1 of the ICH M11 protocol guideline: Definitions of Medical Device Product Complaints.
ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and Reporting
The title of section 9.2 of the ICH M11 protocol guideline: Timing and Procedures for Collection and Reporting.
The title of section 9.2.1 of the ICH M11 protocol guideline: Timing.
ICH M11 Protocol Section 9.2.2 Collection Procedures
The title of section 9.2.2 of the ICH M11 protocol guideline: Collection Procedures.
ICH M11 Protocol Section 9.2.3 Reporting
The title of section 9.2.3 of the ICH M11 protocol guideline: Reporting.
ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting Requirements
The title of section 9.2.3.1 of the ICH M11 protocol guideline: Regulatory Reporting Requirements.
ICH M11 Protocol Section 9.2.4 Adverse Events of Special Interest
The title of section 9.2.4 of the ICH M11 protocol guideline: Adverse Events of Special Interest.
ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
The title of section 9.2.5 of the ICH M11 protocol guideline: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs.
ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information
The title of section 9.3 of the ICH M11 protocol guideline: Pregnancy and Postpartum Information.
ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial
The title of section 9.3.1 of the ICH M11 protocol guideline: Participants Who Become Pregnant During the Trial.
ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial
The title of section 9.3.2 of the ICH M11 protocol guideline: Participants Whose Partners Become Pregnant During the Trial.
ICH M11 Protocol Section 9.4 Special Safety Situations
The title of section 9.4 of the ICH M11 protocol guideline: Special Safety Situations.
ICH M11 Protocol Section Amendment Details
The title of the amendment details section of the ICH M11 protocol guideline: Amendment Details.
Title Page Section of the ICH M11 Protocol standard, Title Page.