Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
The Protocol Questionnaire is used by the Principal Investigator and/or the Study Coordinator to justify the study and request the approval for the study. Contents include a synopsis for non-technical board members and a detailed protocol discussion. Other important sections of form requesting approval for the protocol include work history of the researchers, risks to university personnel performing the research, risk mitigations being undertaken by the researchers, long discussions of the existing body of knowledge and explanations of how the study can be rationalized in light of the existing knowledge on this study topic.
| LinkId | Text | Cardinality | Type | Flags | Description & Constraints |
|---|---|---|---|---|---|
  Protocol_questionnaire | Questionnaire | ||||
  p1 | Research Study | 0..1 | group | ||
  p1.1 | Study Type | 1..1 | choice | Definition: 2 Options: 2 options | |
  p1.1_help | Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional) | 0..1 | display | ||
| p1.2 | Intervention | 0..1 | choice | Definition: i514 Enable When: Options: 4 options | |
| p1.2_help | A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise. | 0..1 | display | ||
| p1.3 | Does this protocol require an FDA exemption? | 0..1 | choice | Definition: i520x Enable When: Options: 2 options | |
| p1.4 | Type of exemption | 0..1 | open-choice | Definition: i521x Enable When: Options: 2 options | |
 p1.5 | Study Title | 0..1 | text | ||
| p1.5_help | The official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s) | 0..1 | display | ||
| p1.6 | Study Title (Short) | 0..1 | text | ||
| p1.6_help | A short study title written in language intended for the lay public. | 0..1 | display | ||
| p1.61 | Principal Investigator | 0..1 | group | ||
| p1.61_help | The individual(s) designated by the applicant organization/recipient to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the official(s) at the applicant organization/recipient, or as appropriate, to a collaborating organization for the proper conduct of the project, program, or activity including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI. (NIH Definition). https://grants.nih.gov/grants/policy/nihgps/html5/section_1/1.2_definition_of_terms.htm | 0..1 | display | ||
| p1.7.1 | First Name | 0..1 | text | ||
| p1.7.1_help | First or given name associated with the site principal investigator | 0..1 | display | ||
| p1.7.2 | Last Name | 0..1 | text | ||
| p1.7.2_help | Last name associated with the principal investigator | 0..1 | display | ||
 p1.7.7 | Suffix | 0..1 | string | ||
| p1.7.7_help | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the principal investigator's name | 0..1 | display | ||
| p1.7.8 | Degree(s) | 0..1 | string | ||
| p1.7.8_help | Professional and Academic degrees associated with the Principal Investigator | 0..1 | display | ||
| p1.7.3 | Department Name | 0..1 | text | ||
| p1.7.4 | Address | 0..1 | group | ||
| p1.7.4.1 | Street Address | 0..1 | text | ||
| p1.7.4.2 | City | 0..1 | text | ||
| p1.7.4.3 | State | 0..1 | text | ||
| p1.7.4.4 | Zip Code | 0..1 | text | ||
| p1.7.4.5 | Country | 0..1 | text | ||
| p1.7.5 | Phone | 0..1 | text | ||
| p1.7.6 | 0..1 | text | |||
| p1.7 | Additional Investigator | 0..1 | choice | Definition: 18_1 Options: 2 options | |
| p1.7_help | PI at additional sites, etc. as applicable | 0..1 | display | ||
| p1.8 | Additional Investigator | 0..* | group | Enable When: | |
| p1.8.1 | Additional Investigator Role | 0..1 | open-choice | Options: 3 options | |
| p1.8.2 | First Name | 0..1 | text | ||
| p1.8.2_help | First or given name associated with the additional investigator | 0..1 | display | ||
| p1.8.3 | Last Name | 0..1 | text | ||
| p1.8.3_help | Surname or family name associated with the additional investigator. | 0..1 | display | ||
| p1.8.8 | Suffix | 0..1 | string | ||
| p1.8.8_help | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the additional investigator's name | 0..1 | display | ||
| p1.8.9 | Degree(s) | 0..1 | string | ||
| p1.8.9_help | Professional and Academic degrees associated with the additional investigator | 0..1 | display | ||
| p1.8.4 | Department Name | 0..1 | text | ||
| p1.8.5 | Address | 0..1 | group | ||
| p1.8.5.1 | Street Address | 0..1 | text | ||
| p1.8.5.2 | City | 0..1 | text | ||
| p1.8.5.3 | State | 0..1 | text | ||
| p1.8.5.4 | Zip Code | 0..1 | text | ||
| p1.8.5.5 | Country | 0..1 | text | ||
| p1.8.6 | Phone | 0..1 | text | ||
| p1.8.7 | 0..1 | text | |||
| p1.9 | IRB Protocol Number | 0..1 | text | ||
| p1.9_help | Provided by the sIRB. Will not be available at the time of initial submission. | 0..1 | display | ||
| p1.10 | Sponsor Protocol Number | 0..1 | text | ||
| p1.10_help | Unique Protocol Identification Number used by the sponsor. | 0..1 | display | ||
| p1.11 | ClinicalTrials.Gov Identifier | 0..1 | string | Enable When: | |
| p1.11_help | The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). | 0..1 | display | ||
| p1.12 | Grant Title | 0..1 | text | Enable When: | |
| p1.13 | NIH Grant Number | 0..1 | text | Enable When: | |
| p1.14 | IND Number | 0..1 | text | Enable When: | |
| p1.15 | IDE Number | 0..1 | text | Enable When: | |
| p1.16 | Study Product Name | 0..1 | text | Enable When: | |
| p1.16_help | Generic, followed by marketed name if applicable | 0..1 | display | ||
| p1.17 | Study Product Provider | 0..1 | text | Enable When: | |
| p1.17_help | e.g. NIH, or company | 0..1 | display | ||
| p1.18 | Funding Organization | 0..1 | group | ||
| p1.18_help | e.g. NIH, or company | 0..1 | display | ||
| p1.18.1 | Name | 0..1 | text | ||
| p1.18.2 | Address | 0..1 | group | Enable When: | |
| p1.18.2.1 | Street Address | 0..1 | text | ||
| p1.18.2.2 | City | 0..1 | text | ||
| p1.18.2.3 | State | 0..1 | text | ||
| p1.18.2.4 | Zip Code | 0..1 | text | ||
| p1.18.3 | Phone Number | 0..1 | text | ||
| p1.19 | Sponsor | 0..1 | group | Enable When: | |
| p1.19_help | Individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization taking responsibility for and investing in a clinical investigation. . The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.21 CFR 312.3 | 0..1 | display | ||
| p1.19.1 | Name | 0..1 | text | ||
| p1.19.2 | Department Name | 0..1 | text | ||
| p1.19.3 | Address | 0..1 | group | ||
| p1.19.3.1 | Street Address | 0..1 | text | ||
 p1.19.3.1.1 | City | 0..1 | text | ||
| p1.19.3.1.2 | State | 0..1 | text | ||
| p1.19.3.1.3 | Zip Code | 0..1 | text | ||
| p1.19.3.1.4 | Country | 0..1 | text | ||
| p1.19.4 | 0..1 | text | |||
| p1.19.5 | Phone Number | 0..1 | text | ||
| p1.20 | Medical Monitor | 0..1 | group | ||
| p1.20_help | Medical expert for the trial | 0..1 | display | ||
| p1.20.1 | Given Name | 0..1 | text | ||
| p1.20.1_help | Given name associated with the medical monitor | 0..1 | display | ||
| p1.20.2 | Last Name | 0..1 | text | ||
| p1.20.2_help | Surname or family name associated with the medical monitor | 0..1 | display | ||
| p1.20.6 | Suffix | 0..1 | string | ||
| p1.20.6_help | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the medical monitor's name | 0..1 | display | ||
| p1.20.7 | Degree(s) | 0..1 | string | ||
| p1.20.7_help | Professional and Academic degrees associated with the medical monitor | 0..1 | display | ||
| p1.20.3 | Phone Number | 0..1 | text | ||
| p1.20.4 | 0..1 | text | |||
| p1.20.5 | Address | 0..1 | group | ||
| p1.20.5.1 | Street Address | 0..1 | text | ||
| p1.20.5.2 | City | 0..1 | text | ||
| p1.20.5.3 | State | 0..1 | text | ||
| p1.20.5.4 | Zip Code | 0..1 | text | ||
| p1.20.5.5 | Country | 0..1 | text | ||
| p1.21 | Confidentialty Statement | 0..1 | text | ||
| p1.22 | Investigator's Signature | 0..1 | text | Enable When: | |
| p1.23 | Protocol Version Number | 0..1 | text | ||
 p1.24 | Protocol Version Date | 0..1 | date | ||
| p2 | Protocol Amendment Summary of Changes Table | 0..* | group | ||
| p2.1 | Affected Section(s) | 0..1 | text | ||
| p2.2 | Summary of Revisions Made | 0..1 | text | ||
| p2.3 | Rationale | 0..1 | text | ||
| p2.4 | Statement of Compliance | 1..1 | text | Initial Value: string = [Choose Sample Text]1.The trial will be carried out in accordance with International Council on Harmonisation Good Clinical Practice (ICH GCP) and the following: tUnited States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for the conduct, management, or oversight of NIH-funded clinical trials have completed Human participants Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must be obtained before any participant is consented. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) will be IRB approved; a determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form. 2.The trial will be carried out in accordance with International Council on Harmonisation Good Clinical Practice (ICH GCP) and the following: tUnited States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for the conduct, management, or oversight of NIH-funded clinical trials have completed Human participants Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must be obtained before any participant is consented. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) will be IRB approved; a determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form. | |
| p2.4_help | Provide a statement that the trial will be conducted in compliance with the protocol, International Council on Harmonisation Good Clinical Practice (ICH GCP) and applicable state, local and federal regulatory requirements. Each engaged institution must have a current Federal-Wide Assurance (FWA) issued by the Office for Human Research Protections (OHRP) and must provide this protocol and the associated informed consent documents and recruitment materials for review and approval by an appropriate Institutional Review Board (IRB) or Ethics Committee (EC) registered with OHRP. Any amendments to the protocol or consent materials must also be approved before implementation. Select one of the two statements below. If the study is an intramural NIH study, use the second statement below: | 0..1 | display | ||
| p3 | Protocol Summary | 0..1 | group | ||
| p3.1 | Synopsis | 0..1 | group | ||
| p3.1.1 | Title (Full) | 0..1 | text | ||
| p3.1.2 | Title (Short) | 0..1 | text | ||
| p3.1.3 | Study Description | 0..1 | text | ||
| p3.2.3_help | Short description of the protocol, including a brief statement of the study hypothesis. This should be only a few sentences in length. A detailed schematic describing all visits and a schedule of assessments should be includedin the Schema and Schedule of Activities | 0..1 | display | ||
| p3.1.4 | Objectives | 0..1 | text | ||
| p3.1.4_help | Include the primary and secondary objectives.Theseobjectives should be thesame as the objectives contained in the body of the protocol. These align with Primary Purpose in clinicaltrials.gov | 0..1 | display | ||
| p3.1.5 | End Points | 0..1 | text | ||
| p3.1.5_help | Primary endpoint and secondary endpoints.These endpoints should be thesame as the endpoints contained in the body of the protocol. These align with Outcome Measures in clinicaltrials.gov | 0..1 | display | ||
 p3.1.6 | Accrual Ceiling/Number of Participants (projected-for all sites) | 0..1 | integer | ||
| p3.1.6_help | Sample size plus an estimate for persons found to be ineligible during screening, after signing a screening consent. Number is the accrual ceiling for participants projected for all sites | 0..1 | display | ||
| p3.1.7 | Study Population | 0..1 | text | ||
| p3.1.7_help | Specify sample size, gender, age, demographic group, general health status, and geographic location. | 0..1 | display | ||
| p3.1.8 | Phase | 0..1 | choice | Definition: 59 Options: 3 options | |
| p3.1.8_help | Applies to drugs and biologics. | 0..1 | display | ||
| p3.1.9 | Description of Sites/Facilities Enrolling Participants | 0..1 | text | ||
| p3.1.9_help | Brief description of planned facilities/participating sites enrolling participants. Indicate number of sites and if the study is intended to include sites outside the United States. | 0..1 | display | ||
| p3.1.10 | Description of Study Intervention ( Agent/Procedure)/Investigational Product | 0..1 | text | ||
| p3.1.10_help | Describe the study intervention. If the study interventionis a drug or biologic, include dose and route of administration. For devices,provide a description ofeach important component, ingredient,property and the principle of operation of the device. | 0..1 | display | ||
| p3.1.11 | Study Duration | 0..1 | text | ||
| p3.1.11_help | Estimated time (in months) from when the study opens to enrollment until completion of data analyses | 0..1 | display | ||
| p3.1.12 | Participant Duration | 0..1 | text | ||
| p3.1.12_help | Time (e.g., in months) it will take for each individual participant to complete all participant visits. | 0..1 | display | ||
| p3.1.13 | Methodology | 0..1 | text | ||
| p3.1.13_help | Design attributes such as single blind, double blind or open label; Randomized, placebo or active placebo control; cross-over design, etc. | 0..1 | display | ||
| p3.1.14 | Duration of Investigational Product Administration | 0..1 | text | Enable When: | |
| p3.1.14_help | Total duration of investigational product administration (including any open-label lead-in, if applicable). | 0..1 | display | ||
| p3.1.15 | Key Procedures | 0..1 | text | ||
| p1.3.15_help | Procedures that are required for the study (e.g. harvesting of tumor, vaccine, tumor biopsy and blood draws) | 0..1 | display | ||
| p3.1.16 | Main Inclusion/Exclusion Criteria | 0..1 | text | ||
| p3.1.16_help | Entire list of inclusion and exclusion criteria will appear later in the protocol. Only include the key inclusion and exclusion criteria in this section. | 0..1 | display | ||
| p3.1.17 | Reference Theraphy | 0..1 | text | Enable When: | |
| p3.1.17_help | Note if there is a standard reference therapy against which the investigational product is being compared, or if the reference is a placebo | 0..1 | display | ||
| p3.1.18 | Statistical Analysis | 0..1 | text | ||
| p3.1.18_help | A very brief description of the main elements of the statistical methodology to be used in the study. Limit this section to discussion of the analysis of the primary endpoint and perhaps the main secondary endpoint. | 0..1 | display | ||
 p3.2 | Schema | 0..1 | attachment | ||
| p3.2_help | This section should include a diagram that provides a quick âsnapshotâ of the study and ideally be limited to one page. Below are examples of schematics that show the level of detail needed to convey an overview of study design. Depending on the nature of your study, one example may be more appropriate than another. Regardless, the examples included here are intended to guide the development of a schematic that is appropriate to the planned study design and will need to be customized for the protocol. If you utilize Example 1, complete the tables with study-specific information and adapt the table(s) to illustrate your study design. If you utilize Example 2 or 3, revise with study-specific information and adapt the diagram to illustrate your study design (e.g., changing method of assignment to study group, adding study arms, visits, etc.). The time point(s) indicated in the schematic should correspond to the time point(s) in Section 7.3, Study Schedule, e.g., Visit 1, Day 0; Visit 2, Day 30 ± 7; etc. | 0..1 | display | ||
| p3.3 | Schedule of Activities | 0..1 | attachment | ||
| p3.3_help | The schedule of activities must capture the procedures that will be accomplished at each study visit, and all contact, with study participants e.g., telephone contacts. This includes any tests that are used for eligibility, participant randomization or stratification, or decisions on study intervention discontinuation. Only include procedures that contribute to participant eligibility and study objectives and endpoints. Other procedures should be done sparingly and with consideration, as they may add unnecessary complexity and detract from recruitment. | 0..1 | display | ||
| p4 | INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONAL | 0..1 | group | ||
| p4.1 | Background | 0..1 | group | ||
| p4.1.1 | Describe the relevant literature and the specific gaps in current knowledge that this study intends to address | 0..1 | text | ||
| p4.1.1_help | Gaps that this study intends to address based on literature | 0..1 | display | ||
| p4.1.2 | Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how it will add to existing knowledge: | 0..1 | text | ||
| p4.1.2_help | Based on the existing literature and how it will add to existing knowledge | 0..1 | display | ||
| p4.1.3 | Describe the relevance and usefulness of the objectives | 0..1 | text | ||
| p4.1.4 | Is this the first time the study drug, device, or intervention/procedure will be used in humans. | 0..1 | choice | Definition: 59 Options: 2 options | |
| p4.1.5 | If there has been experience with the study drug, device, or intervention/procedure in humans, detail the experience to date: | 0..1 | text | Enable When: | |
| p4.1.5_help | Details If the intervention/drug/device is not the first time used. | 0..1 | display | ||
| p4.1.6 | Investigational Product | 0..1 | group | Enable When: | |
| p4.1.6_help | In this section include the name and description of the study intervention (drug, device, biologic, etc.) This section should contain a description of the investigational agent, its make-up, chemical properties and any relevant physical properties, including any available pharmacologic data.Specify the FDA approval status and include the IND Number or justify how the drug meets the IND Exemption criteria if applicable.For device studies this section should include a description of the device, including category of the device, and overview of its intended use or purpose in the research study. Specify the FDA approval status and include the IDE Number or Non-Significant Risk rationale if applicable. | 0..1 | display | ||
| p4.1.6.1 | Name and Description | 0..1 | text | ||
| p4.1.6.2 | Preclinical Data | 0..1 | text | ||
| p4.1.6.3 | Clinical Data to Date | 0..1 | group | ||
| p4.1.6.3.1 | Human Pharmacokinetics | 0..1 | text | ||
| p4.1.6.3.2 | Clinical Studies in adults | 0..1 | text | ||
| p4.1.6.3.3 | Clinical Studies in Children | 0..1 | text | ||
| p4.1.7 | Is there an active control group? | 0..1 | choice | Definition: 1234d Options: 2 options | |
| p4.1.8 | Active Control Group | 0..1 | group | Enable When: | |
| p4.1.8.1 | Describe any potential bias in the selection of the active control such that there will be an unfair advantage for the investigational intervention. For example, is the active control treatment known to be significantly less effective in this study population than another treatment: | 0..1 | text | ||
| p4.1.8.2 | Is the sample size and the randomization ratio for this active control study ethically justified with regard to the number of participants who will be exposed to the risks of the study. | 0..1 | choice | Options: 2 options | |
| p4.1.8.3 | Is the active control an established effective intervention? | 0..1 | choice | Definition: 69 Options: 2 options | |
| p4.1.8.4 | If no, Clarify how it is ethically justified to use this control in the study | 0..1 | text | Enable When: | |
| p4.2 | Study Rationale | 0..1 | text | ||
| p4.2_help | The problems or question and reason for conducting the study. E.g. explain the population, disease, standard of care (if there is one), and limitations of knowledge or available therapy. | 0..1 | display | ||
| p4.3 | Risk/Benefit Assessment | 0..1 | group | ||
| p4.3.1 | Potential Risks | 0..1 | group | ||
| p4.3.1.1 | List the reasonably foreseeable risks, discomforts, hazards, and/or inconveniences to the participants related to their participation in the research, including risk of unintentional loss of confidentiality. Include a description of the probability, magnitude, duration, reversibility, and potential consequences of the risks. Consider physical, psychological, social, legal, and economic risks: | 0..1 | text | ||
| p4.3.1.2 | State which study interventions may have unknown risks: | 0..1 | text | ||
| p4.3.1.3 | State which study interventions may have risks to an embryo or fetus (if a participant is or becomes pregnant) or to a nursing infant of a study participant: | 0..1 | text | ||
| p4.3.1.4 | Describe risks to people other than the participating participant, e.g., risks to family members, friends, others or risks to the community: | 0..1 | text | ||
| p4.3.1.5 | Are there any risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.):? | 0..1 | choice | Definition: 1235 Options: 2 options | |
| p4.3.1.6 | Risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.): | 0..1 | group | Enable When: | |
| p4.3.1.6.1 | Describe these risks | 0..1 | text | ||
| p4.3.1.6.2 | Describe the procedures that will be put in place to minimize these risks: | 0..1 | text | ||
| p4.3.1.6.3 | Describe how these procedures are adequate for the location where study procedures will be performed: | 0..1 | text | ||
| p4.3.1.7 | Other risks | 0..1 | text | ||
| p4.3.2 | Potential Benefits | 0..1 | group | ||
| p4.3.2.1 | Describe the potential benefits that individual participants may experience from taking part in the research. Include the probability, magnitude, and duration of the potential benefits: | 0..1 | text | ||
| p4.3.2.1_help | Note: Payments and incentives are not considered benbefits. | 0..1 | display | ||
| p4.3.2.2 | Describe any benefit to the population from which the participant is drawn: | 0..1 | text | ||
| p4.3.2.3 | Describe any benefit to science, society, and humanity in general: | 0..1 | text | ||
| p4.3.2.4 | Other benefits | 0..1 | text | ||
| p4.3.3 | Alternatives to Study Participation | 0..1 | group | ||
| p4.3.3.1 | Describe alternatives to participating in this research study (e.g. to decide not participate in the study, alternative treatments, no treatment (palliative care), etc.): | 0..1 | text | ||
| p4.3.3.2 | Describe the standard clinical care that may be an alternative: | 0..1 | text | ||
| p4.3.3.3 | Describe how the participant can receive the research procedures/drug/device used in this study in a non-research setting: | 0..1 | text | ||
| p4.3.3.4 | Other alternatives to study participation | 0..1 | text | ||
| p5 | STUDY PURPOSE, OBJECTIVES OR SPECIFIC AIMS | 0..1 | group | ||
| p5_help | Describe the purpose, specific aims, or objectives of the study | 0..1 | display | ||
| p5.1 | Hypothesis | 0..1 | text | ||
| p5.2 | Primary Objectives | 0..1 | text | ||
| p5.2_help | The primary objective is the main question. This objective generally drives statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing). | 0..1 | display | ||
| p5.3 | Secondary Objectives | 0..1 | text | ||
| p5.3_help | The secondary objective(s) are goals that will provide further information on the use of the intervention. | 0..1 | display | ||
| p5.4 | Tertiary/Exploratory Objectives | 0..1 | text | ||
| p5.4_help | Tertiary/exploratory objective(s) serve as a basis for explaining or supporting findings of primary analyses and for suggesting further hypotheses for later research. | 0..1 | display | ||
| p6 | STUDY ENDPOINTS | 0..1 | group | ||
| p6_help | Provide precise definitions of the study endpoints and criteria for evaluation; if the primary outcomes are derived from several measurements (i.e., composite variables) or if endpoints are based composite variables, then describe precisely how the composite variables are derived. | 0..1 | display | ||
| p6.1 | Primary Endpoints | 0..1 | text | ||
| p6.1_help | The primary endpoint(s) should be clearly specified and its importance and role in the analysis and interpretation of study results should be defined. The primary endpoint(s) is the basis for concluding that the study met its objective (e.g., âthe study winsâ). Often Phase 2 and 3 trials include primary objectives, and therefore primary endpoints, to demonstrate effectiveness. Generally, there should be just one primary endpoint that will provide a clinically relevant, valid, and reliable measure of the primary objective. Additional primary endpoints may require an adjustment to the sample size calculations and p-value threshold. However, this is not always the case. For example, in many trials of medical devices there are primary endpoints for both safety and effectiveness. | 0..1 | display | ||
| p6.1.1 | Justification for Endpoints | 0..1 | text | ||
| p6.1.1_help | Briefly explain why the endpoint(s) were chosen. | 0..1 | display | ||
| p6.2 | Secondary Endpoints | 0..1 | text | ||
| p6.2.1 | Justification for Secondary Endpoints | 0..1 | text | ||
| p6.2_help | Briefly explain why the endpoint(s) were chosen. | 0..1 | display | ||
| p6.3 | Tertiary Endpoints | 0..1 | text | ||
| p6.3_help | Exploratory endpoints should be specified. Exploratory endpoints may include clinically important events that are expected to occur too infrequently to show a treatment effect or endpoints that for other reasons are thought to be less likely to show an effect but are included to explore new hypotheses. | 0..1 | display | ||
| p6.3.1 | Justification for Tertiary Endpoints | 0..1 | text | ||
| p6.3.1_help | Briefly explain why the endpoint(s) were chosen. | 0..1 | display | ||
| p6.4 | Primary Safety endpoints | 0..1 | text | ||
| p6.5 | Secondary Safety endpoints | 0..1 | text | ||
| p6.6 | Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims. | 0..1 | text | ||
| p7 | STUDY DESIGN | 0..1 | group | ||
| p7.1 | Overall Design | 0..1 | text | ||
| p7.1_help | The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. A description of the trial design should be consistent with the Protocol Synopsis and Protocol Schema. | 0..1 | display | ||
| p7.2 | Scientific Rationale for Study Design | 0..1 | text | ||
| p7.2_help | Describe the rationale for the type and selection of control (e.g. placebo, active drug, dose-response, historical) and study design (e.g., non-inferiority as opposed to superiority). Discuss known or potential problems associated with the control chosen in light of the specific disease and intervention(s) being studied. | 0..1 | display | ||
| p7.3 | Justification for Dose | 0..1 | text | Enable When: | |
| p7.4 | Justification for Intervention | 0..1 | text | Enable When: | |
| p7.4_help | Provide a justification for the route of administration, planned maximum dosage, and dosing regimen, including starting dose, of the study intervention(s) and control product(s). | 0..1 | display | ||
| p7.5 | End of Study Definition | 0..1 | text | ||
| p7.5_help | A clinical trial is considered completed when participants are no longer being examined or the last participant's last study visit has occurred. | 0..1 | display | ||
| p7.6 | Screening Activities | 0..1 | text | ||
| p7.7 | Study Intervention Activities | 0..1 | text | ||
| p7.8 | Follow Up Activities | 0..1 | text | ||
| p7.9 | Allocation to Interventional Group | 0..1 | text | ||
| p7.10 | Study/Data Collection Instruments | 0..1 | text | ||
| p7.11 | Research Setting | 0..1 | text | ||
| p8 | STUDY POPULATION | 0..1 | group | ||
| p8.1 | Participant Selection | 0..1 | group | ||
| p8.1.1 | Category/Group (eg. Adults, controls, parents, children) | 0..1 | text | ||
| p8.1.2 | Age Range | 0..1 | text | ||
| p8.1.3 | Maximum Number to be Consented or Reviewed/Collected(include withdrawals and screen failures) | 0..1 | integer | ||
| p8.1.4 | Number Expected to Complete the Study or Needed to Address the Research Question | 0..1 | integer | ||
| p8.1.5 | Total Number of participants | 0..1 | integer | ||
| p8.1.6 | Overall study sample size (if multisite) | 0..1 | integer | ||
| p9 | STUDY ENROLLMENT AND WITHDRAWAL | 0..1 | group | ||
| p9.1 | Eligibility Criteria | 0..1 | group | ||
| p9.1.1 | Inclusion and Exclusion Criteria | 0..1 | group | ||
| p9.1.1.1 | Inclusion Criteria | 0..* | text | ||
| p9.1.1.1_help | Description of criteria that define participants to include in study | 0..1 | display | ||
| p9.1.1.2 | Exclusion Criteria | 0..* | text | ||
| p9.1.1.2_help | Description of criteria that define participants to exclude in study | 0..1 | display | ||
| p9.1.2 | Describe in detail how the eligibility criteria will be assessed and satisfied (e.g., medical record review, physical examination): | 0..1 | text | ||
| p9.1.3 | State who will determine eligibility. Note that those who are designated to determine eligibility must have appropriate training, expertise, and oversight, for example a physician PI or Co-I on a biomedical study: | 0..1 | text | ||
| p9.1.4 | Can study participants participate in another research study while participating in this research study: | 0..1 | choice | Options: 2 options | |
| p9.1.5 | Screen Failures | 0..1 | text | ||
| p9.1.5_help | Participants who are consented to participate in the clinical trial, who do not meet one or more criteria required for participation in the trial during the screening procedures, are considered screen failures. Indicate how screen failures will be handled in the trial, including conditions and criteria upon which re-screening is acceptable, when applicable. | 0..1 | display | ||
| p9.1.6 | Lifestyle Considerations | 0..1 | text | ||
| p9.1.6_help | Describe any restrictions during any parts of the study pertaining to lifestyle and/or diet (e.g., food and drink restrictions, timing of meals relative to dosing, intake of caffeine, alcohol, or tobacco, or limits on activity), and considerations for household contacts. Describe what action will be taken if prohibited medications, treatments or procedures are indicated for care (e.g., early withdrawal). | 0..1 | display | ||
| p9.1.7 | Vulnerable Populations | 0..1 | group | ||
| p9.1.7.1 | Can or will pregnant women be enrolled | 0..1 | choice | Definition: i515 Options: 2 options | |
| p9.1.7.2 | Enrollment of Pregnant Women | 0..1 | group | Enable When: | |
| p9.1.7.2.1 | Describe any preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, that have been conducted that provide data for assessing potential risks to pregnant women and fetuses: | 0..1 | text | ||
| p9.1.7.2.2 | Are there any risk to the fetus from the study interventions or procedures. | 0..1 | choice | Definition: i408 Options: 2 options | |
| p9.1.7.2.3 | Risks to Fetus | 0..1 | text | Enable When: | |
| p9.1.7.2.4 | Do the study interventions or procedures hold out the prospect of direct benefit for the woman or the fetus | 0..1 | choice | Definition: i410 Options: 2 options | |
| p9.1.7.2.5 | Describe benefit for the women or fetus | 0..1 | text | Enable When: | |
| p9.1.7.2.6 | If there is no prospect of benefit to the fetus, clarify whether the risk to the fetus is NOT greater than Minimal Risk, and whether the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means: | 0..1 | text | Enable When: | |
| p9.1.7.2.7 | Describe the biomedical knowledge that is expected to result from this research for this population: | 0..1 | text | ||
| p9.1.7.2.8 | Describe how any risk of this research is the least possible for achieving the objectives of the research: | 0..1 | text | ||
| p9.1.7.2.9 | Describe how mothers providing consent are informed of the reasonably foreseeable impact of the research on the fetus or neonate: | 0..1 | text | ||
| p9.1.7.3 | Can or will the research involve neonates of uncertain viability or non-viable neonates? | 0..1 | choice | Definition: i516 Options: 2 options | |
| p9.1.7.31 | Research involving neonates of uncertain viability or non-viable neonates | 0..1 | group | Enable When: | |
| p9.1.7.3.1 | Describe any preclinical and clinical studies that have been conducted that provide data for assessing potential risks to neonates: | 0..1 | text | ||
| p9.1.7.3.2 | Describe the important biomedical knowledge that will be developed from this research and why it cannot be obtained by other means | 0..1 | text | ||
| p9.1.7.3.3 | Describe whether there will be added risk to the neonate resulting from the research | 0..1 | text | ||
| p9.1.7.3.4 | Describe how individuals providing consent are informed of the reasonably foreseeable impact of the research on the neonate: | 0..1 | text | ||
| p9.1.7.3.5 | No person shall perform or offer to perform an abortion where part or all of the consideration for said performance is that the fetal remains may be used for experimentation or other kind of research or study: | 0..1 | choice | Options: 2 options | |
| p9.1.7.3.6 | Individuals engaged in the research will have no part in determining the viability of a neonate: | 0..1 | choice | Options: 2 options | |
| p9.1.7.3.7 | For non-viable neonates, the vital functions of the neonate will not be artificially maintained and that the research will not terminate the heartbeat or respiration of the neonate: | 0..1 | choice | Options: 2 options | |
| p9.1.7.3.8 | For neonates of uncertain viability, the research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective | 0..1 | choice | Options: 2 options | |
| p9.1.7.4 | Can or will participants who are not yet adults (neonates, children, teenagers) be enrolled? | 0..1 | choice | Definition: i517 Options: 2 options | |
| p9.1.7.5 | Enrollment of participants who are not yet adults (neonates, children, teenagers) | 0..1 | group | Enable When: | |
| p9.1.7.5.1 | I will follow the SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013) to determine whether a prospective participant has or has not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. (e.g., individuals under the age of 18 years). | 0..1 | choice | Options: 2 options | |
| p9.1.7.5.1.1 | If this SOP will not be followed, describe how this (attainment of legal age for consent or not) will be determined: | 0..1 | text | ||
| p9.1.7.5.2 | Describe how permission to participate in the study will be obtained from the parents or legal guardians: | 0..1 | text | ||
| p9.1.7.5.3 | Assent process of children | 0..1 | group | ||
| p9.1.7.5.3.1 | Describe waiting period between informing the prospective participant and obtaining the assent | 0..1 | text | ||
| p9.1.7.5.3.2 | Describe any process to ensure ongoing assent | 0..1 | text | ||
| p9.1.7.5.3.3 | Describe Research team members involved in the assent process: | 0..1 | text | ||
| p9.1.7.5.3.4 | Describe how long children will have to consider study participation: | 0..1 | text | ||
| p9.1.7.5.3.5 | Describe steps that will be taken to minimize the possibility of coercion or undue influence: | 0..1 | text | ||
| p9.1.7.5.3.6 | Describe steps that will be taken to ensure the participants's understanding: | 0..1 | text | ||
| p9.1.7.5.3.7 | If assent will not be obtained from children, specify why: | 0..1 | text | ||
| p9.1.7.5.3.8 | Will children reach 18 years of age while in the study? | 0..1 | choice | Definition: i521 Options: 2 options | |
| p9.1.7.5.3.9 | Children reaching 18 years of age while in the study | 0..1 | group | Enable When: | |
| p9.1.7.5.1.9.1 | Describe the plan to obtain written informed consent from the participant at age 18 years: | 0..1 | text | ||
| p9.1.7.5.1.9.2 | Describe who will be responsible for managing the plan: | 0..1 | text | ||
| p9.1.7.5.1.9.3 | Describe where the consent discussion will take place: | 0..1 | text | ||
| p9.1.7.5.1.9.4 | Describe what will happen if the participant cannot be located to provide consent at age 18 years: | 0..1 | text | ||
| p9.1.7.6 | Can or will minors who are: i)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs be approached for study participation for either themselves or their child? | 0..1 | choice | Definition: i518 Options: 2 options | |
| p9.1.7.7 | Enrollment of minors who are: i)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs be approached for study participation for either themselves or their child. | 0..1 | group | Enable When: | |
| p9.1.7.7.1 | Describe how will it be determined that this population has the capacity to consent for this study. Please note that the circumstance of parenthood, pregnancy, etc. may not mean that the person has the same capacity of an adult who can understand the risks, benefits, and alternatives for indicated care. Thus, sound and sensitive clinical judgment that is attentive to both the minorrights and the minoractual competence and needs must be considered, and is to include a determination as to whether involvement of family or other adults familiar to the minor is necessary and appropriate: | 0..1 | text | ||
| p9.1.7.7.2 | Describe how informed consent will be executed with this population in a way that allows for independent and thoughtful decision-making: | 0..1 | text | ||
| p9.1.7.7.3 | Describe any additional steps or procedures that will be used when performing informed consent with this population: | 0..1 | text | ||
| p9.1.7.8 | Can or will cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent be enrolled? | 0..1 | choice | Definition: i522 Options: 2 options | |
| p9.1.7.9 | Enrollment of cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent | 0..1 | group | Enable When: | |
| p9.1.7.9.1 | Describe whether the research holds out a prospect of direct benefit to the individual participant that is unavailable outside the research context | 0..1 | text | ||
| p9.1.7.9.2 | Describe why the objectives of the study cannot be met by enrolling participants who are able to give consent | 0..1 | text | ||
| p9.1.7.9.4 | Describe the process to determine whether or not the individual is capable of consent: | 0..1 | text | ||
| p9.1.7.9.5 | Describe who will determine if the participant is able to provide informed consent: | 0..1 | text | ||
| p9.1.7.9.6 | Describe how it will be determined whether the participant is able to provide informed consent: | 0..1 | text | ||
| p9.1.7.9.7 | Describe when and how often (even after obtaining informed consent) it will be determined whether the participant is able to provide informed consent | 0..1 | text | ||
| p9.1.7.9.8 | List the individuals from whom permission will be obtained if the participant cannot provide informed consent. Prioritize the list (e.g., durable power of attorney for health care, court appointed guardian for health care decisions, spouse, and adult child.): | 0..1 | text | ||
| p9.1.7.9.9 | If it is possible that participants may regain capacity to provide informed consent during the study, describe how frequently this will be assessed and state that participants will be consented to the study in the event that they regain capacity to provide informed consent | 0..1 | text | ||
| p9.1.7.9.10 | Process for assent of participants | 0..1 | group | ||
| p9.1.7.9.10.1 | Describe whether assent will be required of all, some, or none of the participants. If some, specify which participants will be required to assent and which will not: | 0..1 | text | ||
| p9.1.7.9.10.2 | If assent will not be obtained from some or all participants, an explanation of why not: | 0..1 | text | ||
| p9.1.7.9.10.3 | Describe whether assent of the participants will be documented and the process to document assent. The IRB allows the person obtaining assent to document assent on the consent document and does not routinely require assent documents and does not routinely require participants to sign assent documents: | 0..1 | text | ||
| p9.1.7.9.11 | Provide a description of how the patient will be informed of the potential risks and benefits of the study and any procedures associated with its use: | 0..1 | text | ||
| p9.1.7.9.12 | Participants will be withdrawn if they appear to be unduly distressed at any time during the study. | 0..1 | choice | Options: 2 options | |
| p9.1.7.10 | Can or will prisoners be enrolled? | 0..1 | choice | Definition: i476 Options: 2 options | |
| p9.1.7.11 | Enrollment of prisoners | 0..1 | group | Enable When: | |
| p9.1.7.11.1 | Describe any possible advantages accruing to the Prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired: | 0..1 | text | ||
| p9.1.7.11.2 | Describe whether the risks involved in the research are commensurate with risks that would be accepted by non-Prisoner volunteers | 0..1 | text | ||
| p9.1.7.11.3 | Describe procedures for the selection of participants within the prison which are fair to all Prisoners and immune from arbitrary intervention by prison authorities or Prisoners. Unless the Principal Investigator provides to the Board justification in writing for following some other procedures, control participants must be selected randomly from the group of available Prisoners who meet the characteristics needed for that particular research project: | 0..1 | text | ||
| p9.1.7.11.4 | Parole boards will not take into account a Prisoner participation in the research in making decisions regarding parole, and each Prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole. | 0..1 | choice | Options: 2 options | |
| p9.1.7.11.5 | A letter of support from the Prison this research will be conducted in has been submitted to the IRB. | 0..1 | choice | Options: 2 options | |
| p9.1.7.11.6 | If follow-up examination or care of participants after the end of their participation is required, describe the provision for such examination or care, taking into account the varying lengths of individual Prisoners sentences, and for informing participants of this fact: | 0..1 | text | ||
| p9.1.7.12 | Can or will students and/or employees be enrolled in this research? | 0..1 | choice | Definition: i484 Options: 2 options | |
| p9.1.7.13 | Enrollment of students and/or employees | 0..1 | group | Enable When: | |
| p9.1.7.13.1 | Describe the justification for specifically targeting recruitment efforts to enroll students and/or employees: | 0..1 | text | ||
| p9.1.7.13.2 | Describe how potential coercion will be eliminated | 0..1 | text | ||
| p9.1.7.13.3 | Describe the recruitment methods to be applied specifically to students and/or employees. If the same recruitment methods previously described in the protocol will be used, then state that: | 0..1 | text | ||
| p9.1.7.13.4 | Describe additional safeguards included to protect the rights and welfare of students and employees: | 0..1 | text | ||
| p9.1.7.13.5 | Describe protections to ensure that a participant's decision about participation and/or early withdrawal from the study will not affect his/her status as a student or employee: | 0..1 | text | ||
| p9.1.7.13.6 | Submitted a letter from the appropriate institutional official (e.g., Department Chair, Dean, Vice-President) who oversees the students and/or employees attesting to the fact that the employeeor studentparticipation in the research is acceptable and that coercion has been minimized. | 0..1 | choice | Options: 2 options | |
| p9.1.7.14 | Can or will wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody)? | 0..1 | choice | Definition: i519 Options: 2 options | |
| p9.1.7.15 | Enrollment of wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody). | 0..1 | group | Enable When: | |
| p9.1.7.15.1 | Describe the justification for recruiting and enrolling this population | 0..1 | text | ||
| p9.1.7.15.2 | Describe any additional details about the recruitment methods to be used. If the same recruitment methods previously described in the protocol will be used, then state that: | 0..1 | text | ||
| p9.1.7.15.3 | Describe any additional details about the informed consent process to be used. If the same informed consent process for enrolling minors previously described in the protocol will be used, then state that: | 0..1 | text | ||
| p9.1.7.15.4 | Describe how it will be ensured that the appropriate person(s) grants permission for each ward to participate in the research: | 0..1 | text | ||
| p9.1.7.15.5 | Describe how the research team will know if there has been a change in guardianship status during the course of the research and how permission will be obtained from the new guardian: | 0..1 | text | ||
| p9.1.7.15.6 | Is the study is greater than minimal risk? | 0..1 | choice | Definition: i520 Options: 2 options | |
| p9.1.7.15.7 | Greater than minimal risk study | 0..1 | group | Enable When: | |
| p9.1.7.15.7.1 | Describe whether the research is related to their status as wards OR if the research is conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards | 0..1 | text | ||
| p9.1.7.15.7.2 | Describe how an advocate will be appointed for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis | 0..1 | text | ||
| p9.1.7.15.7.3 | Describe the background and experience of the advocate to act in the best interests of the child for the duration of the childparticipation in the research: | 0..1 | text | ||
| p9.1.7.15.7.4 | The advocate will not be associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization. | 0..1 | choice | Options: 2 options | |
| p9.2 | STRATEGIES FOR RECRUITMENT AND RETENTION | 0..1 | group | ||
| p9.2.1 | Recruitment Methods | 0..1 | group | ||
| p9.2.1.1 | Describe when, where, and how potential participants will be recruited | 0..1 | text | ||
| p9.2.1.1_help | Provide a broad overview of the recruitment activities. Specific media, content, duration and scripts will be gathered on the Recruitment Materials Questionnaire. | 0..1 | display | ||
| p9.2.1.2 | When participants respond to recruitment material, describe the information that will be collected from participants (e.g. name, telephone number, etc.). | 0..1 | text | ||
| p9.2.1.3 | Describe source of participants (for example, patient population, local community, etc.): | 0..1 | text | ||
| p9.2.1.4 | Describe methods that will be used to identify potential participants: | 0..1 | text | ||
| p9.2.1.5 | Describe how the recruitment methods described will be effective in attracting the targeted participant population: | 0..1 | text | ||
| p9.3 | DURATION OF STUDY PARTICIPATION. (If there are sub-studies, include duration of participation in each sub-study.) | 0..1 | text | ||
| p10 | STUDY INTERVENTION | 0..1 | group | Enable When: | |
| p10.1 | Study Agent | 0..1 | group | ||
| p10.1.1 | Study Agent and Control Description | 0..1 | text | ||
| p10.1.2 | Receipts/Acquisition | 0..1 | text | ||
| p10.1.2_help | State how the study intervention and control product will be provided to the investigator, including who will be supplying the investigational product and any other protocol dictated medications/devices. If investigational product(s) will be purchased through commercial sources, state this. | 0..1 | display | ||
| p10.1.3 | Study Agent Accountability/ Return or Destruction of Investigational Product | 0..1 | text | ||
| p10.1.3_help | Describe plans about how and by whom the study intervention will be distributed, including participation of a drug repository or pharmacy, and plans for disposal of expired or return of unused product. | 0..1 | display | ||
| p10.1.4 | Formulation and appearance of Control Product | 0..1 | text | ||
| p10.1.4_help | Describe the formulation and appearance the study intervention, as supplied. Information in this section can usually be obtained from the IB or the package insert, or device labeling. This section should include the name of the manufacturer of the control product. | 0..1 | display | ||
| p10.1.5 | Formulation and appearance of Test Product | 0..1 | text | ||
| p10.1.5_help | Describe the formulation and appearance the study intervention, as supplied. Information in this section can usually be obtained from the IB or the package insert, or device labeling. This section should include the name of the manufacturer of the control product. | 0..1 | display | ||
| p10.1.6 | Packaging and Labeling | 0..1 | text | ||
| p10.1.6_help | Describe the packaging and labeling of the study intervention and control product, as supplied. Information in this section can usually be obtained from the IB or the package insert, or device labeling. | 0..1 | display | ||
| p10.1.7 | Product Storage and Stability | 0..1 | text | ||
| p10.1.7_help | Describe storage and stability requirements (e.g., protection from light, temperature, humidity) for the study intervention and control product. For studies in which multi-dose vials are utilized, provide additional information regarding stability and expiration time after initial use (e.g., the seal is broken). | 0..1 | display | ||
| p10.1.8 | Preparation | 0..1 | text | ||
| p10.1.8_help | Describe the preparation of the study intervention and control product, including any preparation required by study staff and/or study participants. Include thawing, diluting, mixing, and reconstitution/preparation instructions in this section, as appropriate, or within a MOP or SOP. For devices, include any relevant assembly or use instructions. | 0..1 | display | ||
| p10.1.9 | Administration and/or Dosing | 0..1 | text | ||
| p10.1.9_help | Describe the procedures for selecting each participant's dose of study intervention and control product. For drugs, that includes the timing of dosing (e.g., time of day, interval), the duration (e.g., the length of time study participants will be administered the study intervention), the planned route of administration (e.g., oral, nasal, intramuscular), and the relation of dosing to meals. | 0..1 | display | ||
| p10.1.10 | Route of Administration | 0..1 | text | ||
| p10.1.11 | Starting Dose and Dose Escalation Schedule | 0..1 | text | ||
| p10.1.11_help | State the starting dose and schedule of the study intervention and control product, including the maximum and minimum duration for those participants who continue in the study. For example, in some oncology trials for participants with no available therapeutic alternatives, intervention continues even after disease progression. In this instance, consider alternative designs that enable participants to rollover to a continued treatment arm and include appropriate instructions to guide this implementation. | 0..1 | display | ||
| p10.1.12 | Dose Adjustments/Modifications/Delays | 0..1 | text | ||
| p10.1.13 | Duration of Therapy | 0..1 | text | ||
| p10.1.14 | Tracking Dose | 0..1 | text | ||
| p10.1.15 | Device Specific Considerations | 0..1 | text | ||
| p10.1.16 | Administration Instructions | 0..1 | text | ||
| p10.1.17 | Dispensing [authority, requirements] | 0..1 | text | ||
| p10.1.18 | Supply of Study Drug at the Site | 0..1 | text | ||
| p10.2 | Study Behavioral or Social Intervention(s) | 0..1 | group | Enable When: | |
| p10.2.1 | Administration of Intervention | 0..1 | text | ||
| p10.2.2 | Procedures for Training Interventionalists and Monitoring Intervention Fidelity | 0..1 | text | ||
| p10.2.3 | Assessment of participant Compliance with Study Intervention | 0..1 | text | ||
| p10.3 | Study Procedural Intervention(s) Description | 0..1 | group | ||
| p10.3.1 | Administration of Procedural Intervention | 0..1 | text | ||
| p10.3.2 | Procedures for Training of Clinicians on Procedural Intervention | 0..1 | text | ||
| p10.3.3 | Assessment of Clinician and/or Participant Compliance with Study Procedural Intervention | 0..1 | text | ||
| p10.3.3_help | Define how adherence to the protocol (e.g., administration of study intervention, use of device,) will be assessed, and verified (if applicable, e.g., plasma assays, electronic monitoring devices, daily diaries). Include a discussion of what documents are mandatory to complete (e.g., participant drug log) and what source documents/records will be used to calculate study intervention compliance. | 0..1 | display | ||
| p10.4 | Participant Compliance and Monitoring | 0..1 | text | ||
| p10.5 | Study Intervention/Experimental Manipulation Adherence | 0..1 | text | ||
| p11 | STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL | 0..1 | group | ||
| p11.1 | Discontinuation of Study Intervention | 0..1 | text | ||
| p11.2 | Participant withdrawal and Termination | 0..1 | group | ||
| p11.2_help | Participants may withdraw voluntarily from the study or the PI may discontinue a participant from the study. This section should state which adverse events would result in discontinuation of study intervention or participant discontinuation/withdrawal. In addition, participants may discontinue the study intervention, but remain in the study for follow-up, especially for safety and efficacy study endpoints (if applicable). Consider requiring separate documentation for study intervention discontinuation and participant discontinuation/withdrawal from the study. In addition, a dedicated Case Report Form (CRF) page should capture the date and the specific underlying reason for discontinuation of study intervention or participant discontinuation/withdrawal. | 0..1 | display | ||
| p11.2.1 | Reasons for Withdrawal or Termination | 0..1 | text | ||
| p11.2.2 | Handling of Participant Withdrawal or Termination | 0..1 | text | ||
| p11.2.3 | Replacement of participants | 0..1 | text | ||
| p11.3 | Lost to Follow-Up | 0..1 | text | ||
| p11.3_help | The protocol should describe the nature and duration of study follow-up. Validity of the study is a potential issue when participants are lost to follow-up, as information that is important to the endpoint evaluation is then lost. Participants are considered lost to follow-up when they stop reporting to scheduled study visits and cannot be reached to complete all protocol-required study procedures. Describe the plans to minimize loss to follow-up and missing data. | 0..1 | display | ||
| p12 | STUDY PROCEDURES | 0..1 | group | ||
| p12.1 | Study Procedures/Evaluations | 0..1 | group | ||
| p12.1.1 | Study Specific Procedures | 0..1 | text | ||
| p12.1.2 | Standard of Care Study Procedures | 0..1 | text | ||
| p12.2 | Laboratory Procedures/Evaluations | 0..1 | group | ||
| p12.2.1 | Clinical Laboratory Evaluations | 0..1 | text | ||
| p12.2.2 | Research Laboratory Evaluations | 0..1 | text | ||
| p12.2.3 | Other Assays or Procedures | 0..1 | text | ||
| p12.2.4 | Specimen Preparation, Handling, and Storage | 0..1 | text | ||
| p12.2.5 | Specimen Shipment | 0..1 | text | ||
| p12.3 | Data Collection and Follow Up for Withdrawn participants | 0..1 | text | ||
| p12.4 | Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception). | 0..1 | text | ||
| p12.5 | Precautionary Medications, Treatments, and Procedures | 0..1 | text | ||
| p12.6 | Prohibited Medications, Treatments, and Procedures | 0..1 | text | ||
| p12.7 | Prophylactic Medications, Treatments, and Procedures | 0..1 | text | ||
| p12.8 | Rescue Medications, Treatments, and Procedures | 0..1 | text | ||
| p12.8_help | List all medications, treatments, and/or procedures that may be provided during the study for "rescue therapy" and relevant instructions about administration of rescue medications. | 0..1 | display | ||
| p12.9 | Participant Access to Study Agent at Study Closure | 0..1 | text | ||
| p12.10 | Concomitant Medications, Treatments , and Procedures | 0..1 | text | ||
| p12.10_help | This section should be consistent with the medication restrictions in the inclusion/exclusion criteria previously listed. Describe the data that will be recorded related to permitted concomitant medications, supplements, complementary and alternative therapies, treatments, and/or procedures. Include details about when the information will be collected (e.g., screening, all study visits). Describe how allowed concomitant therapy might affect the outcome (e.g., drug-drug interaction, direct effects on the study endpoints) and how the independent effects of concomitant and study interventions could be ascertained. | 0..1 | display | ||
| p13 | SCHEDULE OF STUDY PROCEDURES | 0..1 | group | ||
| p13.1 | Screening | 0..1 | text | ||
| p13.2 | Enrollment/Visit 1/Baseline Visit | 0..1 | text | ||
| p13.3 | Intermediate Visits | 0..* | text | ||
| p13.4 | Final Study Visit | 0..1 | text | ||
| p13.5 | Withdrawal/Early Termination Visit | 0..1 | text | ||
| p13.6 | Unscheduled Visit | 0..1 | text | ||
| p13.7 | Follow Up Phase of the Study | 0..1 | group | ||
| p13.7.1 | Visit | 0..* | text | ||
| p13.7.2 | End of Study Visit | 0..1 | text | ||
| p14 | ASSESSMENT OF SAFETY | 0..1 | group | ||
| p14_help | The following subsections are intended to highlight the specific assessments related to safety and the aspects of the study which are proposed to ensure the safety of trial participants. Consider developing this section in consultation with the study Medical Monitor. Consider the risks of the study intervention and other study procedures and the characteristics of the study population (e.g., vulnerable populations such as children). | 0..1 | display | ||
| p14.1 | Specification of Safety Parameters | 0..1 | group | ||
| p14.1.1 | Definition of Adverse Events(AE) | 0..1 | text | ||
| p14.1.1_help | Provide the definition of an AE being used for the clinical trial. The FDA definition of an AE is used in this template since this template is for IND and IDE studies. For some studies, definitions from the OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events; or ICH GCP definition may be more appropriate. However, it is important to note that FDA regulations require reporting based on the definition included in 21 CFR 312.32 (a) for studies performed under an IND, regardless of the definition of AE used in the protocol. | 0..1 | display | ||
| p14.1.2 | Definition of Serious Adverse Events (SAE) | 0..1 | text | ||
| p14.1.2_help | Provide the definition of an SAE being used for the clinical trial. The FDA definition of an SAE is used in this template since this template is for IND and IDE studies. It is important to note that FDA regulations require reporting based on the definition included in 21 CFR 312.32 (a) for studies performed under an IND, regardless of the definition of SAE used in the protocol. Note that the example text provided is from the drug regulations (21 CFR 312.32 (a)). There is no definition for SAE in the device regulations. Therefore, investigators should develop an appropriate definition for their study. This definition could include an unanticipated adverse device effect, but an SAE is broader than that definition. According to 21 CFR 812.3(s), an "unanticipated adverse device effect means any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects." | 0..1 | display | ||
| p14.1.3 | Definition of Unanticipated Problems | 0..1 | text | ||
| p14.1.3_help | The reporting of UPs applies to non-exempt human subjects research conducted or supported by HHS. Provide the definition of an UP being used for this clinical trial. An incident, experience, or outcome that meets the definition of an UP generally will warrant consideration of changes to the protocol or consent in order to protect the safety, welfare, or rights of participants or others. Other UPs may warrant corrective actions at a specific study site. Examples of corrective actions or changes that might need to be considered in response to an UP include: "Modification of inclusion or exclusion criteria to mitigate the newly identified risks" | 0..1 | display | ||
| p14.2 | Classification of an Adverse Event | 0..1 | group | ||
| p14.2.1 | Severity of an Event | 0..1 | text | ||
| p14.2.1_help | All AEs will be assessed by the study clinician using a protocol defined grading system. Describe the method of grading an AE for severity. For example, many toxicity tables are available for use and are adaptable to various study designs. Selection of a toxicity table or severity scale should be made in consultation with the study Medical Monitor. | 0..1 | display | ||
| p14.2.2 | Relationship to Study Intervention/Experimental Manipulation | 0..1 | text | ||
| p14.2.2_help | All AEs will have their relationship to study intervention or study participation assessed with a level of specificity appropriate to the study design. The clinician's assessment of an AE's relationship to study intervention (drug, biologic, device) is part of the documentation process, but it is not a factor in determining what is or is not reported in the study. Describe the method of determining the relationship of an AE to a study intervention. If there is any doubt as to whether a clinical observation is an AE, the event should be reported. Some protocols may use a binary assessment (related/not related); others may have a scale of relatedness. Evaluation of relatedness must consider etiologies such as natural history of the underlying disease, concurrent illness, concomitant therapy, study-related procedures, accidents, and other external factors. In a clinical trial, the study intervention must always be suspect. | 0..1 | display | ||
| p14.2.3 | Expectedness | 0..1 | text | ||
| p14.2.3_help | Expected adverse reactions are AEs that are known to occur for the study intervention being studied and should be collected in a standard, systematic format using a grading scale based on functional assessment or magnitude of reaction. Identify the source of the reference safety information used to determine the expectedness of the AE (e.g., IB, approved labeling). Expectedness is assessed based on the awareness of AEs previously observed, not on the basis of what might be anticipated from the properties of the study intervention. | 0..1 | display | ||
| p14.3 | Time Period and Frequencey for Event Assessment and Follow-Up | 0..1 | text | ||
| p14.4 | Reporting Procedures | 0..1 | group | ||
| p14.4.1 | Notifying the IRB | 0..1 | group | ||
| p14.4.1.1 | Adverse Event Reporting | 0..1 | text | ||
| p14.4.1.1_help | Describe the AE reporting procedures, including timeframes. Further details should be included in a MOP or SOP including a description and a flow chart of when events are reported to various oversight (e.g., Data and Safety Monitoring Board (DSMB), safety monitoring committee, independent safety monitor) and regulatory s, and what study staff are responsible for completing and signing off on the AE reports, and who will receive notification of AEs. According to 21 CFR 312.64(b), "The investigator must record nonserious adverse events and report them to the sponsor according to the timetable for reporting specified in the protocol". | 0..1 | display | ||
| p14.4.1.2 | Serious Adverse Event Reporting | 0..1 | text | ||
| p14.4.1.2_help | Describe the SAE reporting procedures, including timeframes. Further details should be included in a MOP or SOP including a description and a flow chart of when events are reported to various oversight and regulatory s, and what study staff are responsible for completing and signing off on the SAE reports, and who will receive notification of SAEs. | 0..1 | display | ||
| p14.4.1.3 | Unanticipated Problem Reporting | 0..1 | text | ||
| p14.4.1.3_help | This section addresses responsibilities of investigators for reporting of UPs. Describe the UP reporting procedures, including timeframes. Further details should be included in a MOP or SOP including a description and a flow chart of when events are reported to various oversight (e.g., DSMB, safety monitoring committee, independent safety monitor) and regulatory s, and what study staff are responsible for completing and signing off on the UP report forms. Institutions engaged in human subjects research conducted or supported by Department of Health and Human Services (DHHS) must have written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and any supporting department or agency head of any unanticipated problem involving risks to subjects or others (45 CFR 46.103(b)(5)). Furthermore, for research covered by an assurance approved for federal wide use by OHRP, DHHS regulations at 45 CFR 46.103(a) require that institutions promptly report any unanticipated problems to OHRP. Refer to the Reportable Events guidance in IRBear for further details. | 0..1 | display | ||
| p14.4.1.4 | Reporting of Pregnancy | 0..1 | text | ||
| p14.4.1.4_help | State the study's pregnancy-related policy and procedure. Include appropriate mechanisms for reporting to the DCC or NIH, the IND or IDE sponsor, study leadership, IRB, and regulatory agencies. Provide appropriate modifications to study procedures (e.g., discontinuation of study intervention, while continuing safety follow-up, requesting permission to follow pregnant women to pregnancy outcome). | 0..1 | display | ||
| p14.4.2 | Notifyiing the Study Sponsor | 0..1 | text | ||
| p14.4.3 | Notifying the FDA | 0..1 | text | ||
| p14.4.4 | Notifying Participating Investigators | 0..1 | text | ||
| p14.4.5 | Reporting Events to Participants | 0..1 | text | ||
| p14.4.5_help | Describe how participants will be informed about AEs and SAEs, and study-related results on an individual or aggregate level. In addition, describe plans for detecting and managing incidental findings associated with study procedures | 0..1 | display | ||
| p14.4.6 | Events of Special Interest | 0..1 | text | ||
| p14.4.6_help | Describe any other events that merit reporting to the sponsor, study leadership, IRB, and regulatory agencies. For example, in oncology trials, secondary malignancies are often captured. | 0..1 | display | ||
| p14.5 | Follow Up Report | 0..1 | text | ||
| p14.6 | Study Halting/Stopping Rules | 0..1 | text | ||
| p15 | STATISTICAL CONSIDERATIONS | 0..1 | group | ||
| p15.1 | Statistical and Analytical Plans(SAP) | 0..1 | text | ||
| p15.2 | Statistical Hypotheses | 0..1 | text | ||
| p15.2_help | State the formal and testable null and alternative hypotheses for primary and key secondary endpoints, specifying the type of comparison (e.g., superiority, equivalence or non-inferiority, dose response) and time period for which each endpoint will be analyzed. | 0..1 | display | ||
| p15.3 | Analysis Datasets | 0..1 | text | ||
| p15.3_help | Clearly identify and describe the analysis datasets (e.g., which participants will be included in each). | 0..1 | display | ||
| p15.4 | Populations for Analysis | 0..1 | text | ||
| p15.5 | Sample Size Determination | 0..1 | text | ||
| p15.5_help | Include number of participants to recruit, screen, and enroll to have adequate power to test the key hypotheses for the study. Provide all information needed to validate your calculations and judge the feasibility of enrolling and following the necessary number of participants. Further, present calculations from a suitable range of assumptions to gauge the robustness of the proposed sample size.Discuss whether the sample size provides sufficient power for addressing secondary endpoints or exploratory analyses (e.g., sub analyses or moderator analyses involving an interaction term. | 0..1 | display | ||
| p15.6 | Description of Statistical Methods | 0..1 | group | ||
| p15.6.1 | General Approach | 0..1 | text | ||
| p15.6.2 | Analysis of Primary Efficacy Endpoints(s) | 0..1 | text | ||
| p15.6.3 | Analysis of Secondary Endpoint(s) | 0..1 | text | ||
| p15.6.4 | Safety Analyses | 0..1 | text | ||
| p15.6.4_help | Describe how safety endpoints will be analyzed (e.g., as summary statistics during treatment and/or as change scores from baselines such as shift tables). If your study is evaluating a formal safety endpoint, all of the factors to be included in Analysis of the Primary Efficacy Endpoint(s) section should be included here. Describe how AEs will be coded (e.g., Medical Dictionary for Regulatory Activities (MedDRA)), calculated (e.g., each AE will be counted once only for a given participant), presented (e.g., severity, frequency, and relationship of AEs to study intervention will be presented by System Organ Class (SOC) and preferred term ings) and what information will be reported about each AE (e.g., start date, stop date, severity, relationship, expectedness, outcome, and duration). Adverse events leading to premature discontinuation from the study intervention and serious treatment-emergent AEs should be presented either in a table or a listing. The information included here should be consistent with the information contained within Assessment of Safety section. | 0..1 | display | ||
| p15.6.5 | Adherence and Retention Analyses | 0..1 | text | ||
| p15.6.6 | Baseline Descriptive Statistics | 0..1 | text | ||
| p15.6.7 | Planned Interim Analyses | 0..1 | group | ||
| p15.6.7.1 | Safety Review | 0..1 | text | ||
| p15.6.7.2 | Efficacy Review | 0..1 | text | ||
| p15.6.8 | Additional Sub-Group Analyses | 0..1 | text | ||
| p15.6.9 | Multiple Comparison/Multiplicity | 0..1 | text | ||
| p15.6.10 | Tabulation of Individual Response Data | 0..1 | text | ||
| p15.6.11 | Exploratory Analyses | 0..1 | text | ||
| p15.6.12 | Pharmacokinetic Analysis (if applicable) | 0..1 | text | ||
| p15.7 | Sample Size | 0..1 | text | ||
| p15.7_help | Include number of participants to recruit, screen, and enroll to have adequate power to test the key hypotheses for the study. Provide all information needed to validate your calculations and judge the feasibility of enrolling and following the necessary number of participants.Further, present calculations from a suitable range of assumptions to gauge the robustness of the proposed sample size. Discuss whether the sample size provides sufficient power for addressing secondary endpoints or exploratory analyses. | 0..1 | display | ||
| p15.8 | Measures to Minimize Bias | 0..1 | group | ||
| p15.8.1 | Enrollment/Randomization/Masking Procedures | 0..1 | text | ||
| p15.8.2 | Evaluation of Success of Blinding | 0..1 | text | ||
| p15.8.3 | Breaking the Study Blind/Participant Code | 0..1 | text | ||
| p16 | SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | 0..1 | group | ||
| p16.1 | Regulatory, Ethical and Study Oversight Considerations | 0..1 | group | ||
| p16.1.1 | Protocol Amendments | 0..1 | text | ||
| p16.1.2 | Ethical Standard | 0..1 | text | ||
| p16.1.3 | Institutional Review Board | 0..1 | text | ||
| p16.1.4 | Informed Consent Process | 0..1 | group | ||
| p16.1.4.1 | Consent/Assent and Other Informational Documents Provided to Participants | 0..1 | text | ||
| p16.1.4.2 | Consent Procedures and Documentation | 0..1 | group | ||
| p16.1.4.2.1 | Specify how the research team will assure that participants have sufficient time to consider whether to participate in the research | 0..1 | text | ||
| p16.1.4.2.2 | Describe the parental permission process and the child assent process. (If study involves children) | 0..1 | text | ||
| p16.1.4.2.3 | Some participants may be vulnerable to coercion or undue influence, such as those who are economically or educationally disadvantaged, mentally disabled, or students (undergraduate, graduate, and medical students) and employees (administrative, clerical, nursing, lab technicians, post-doctoral fellows and house staff, etc.), describe the procedures to ensure the voluntary participation of these individuals | 0..1 | text | ||
| p16.1.4.2.4 | Methods of Informed Consent for non-English Speakers | 0..1 | text | ||
| p16.1.4.2.5 | Waiver or Alteration of Consent Process | 0..1 | text | ||
| p16.1.4.2.6 | HIPAA Authorization | 0..1 | group | ||
| p16.1.4.2.7.1 | Participant's Capacity to Give Legally Effective Consent | 0..1 | text | ||
| p16.1.4.3 | Indicate where the consent process will take place. | 0..1 | text | ||
| p16.1.5 | Participant data and Confidentialty | 0..1 | group | ||
| p16.1.5.1 | Research Use of Stored Human Samples, Specimens, or Data | 0..1 | text | ||
| p16.1.5.2 | Confidentiality of Research Biospeciemen/Data | 0..1 | text | ||
| p16.1.5.3 | Certificate of Confidentiality (if applicable) | 0..1 | text | ||
| p16.1.5.4 | Provisions to Protect the Privacy of Participants: | 0..1 | text | ||
| p16.1.6 | Future Use of Stored Human Specimens and Data | 0..1 | text | ||
| p16.1.7 | Study Discontinuation and Closure | 0..1 | text | ||
| p16.1.8 | Key Roles and Expertise of Study Team | 0..* | group | ||
| p16.1.8.4_help | Provide a list of persons, companies, and/or groups serving in key roles in the conduct or oversight of the trial. This should include the sponsormedical expert for the trial (medical monitor), investigator responsible for conducting the trial (principal investigator (PI)), qualified clinician responsible for the siteclinical decisions (site investigator), and any clinical laboratory(ies) or other institutions involved in the trial. Other key roles may include the NIH point of contact (program director or officer), regulatory specialist, biostatistician, data coordinating center (DCC), data management center, data manager, or industry partner. | 0..1 | display | ||
| p16.1.8.1 | First Name | 0..1 | text | ||
| p16.1.8.2 | Last Name | 0..1 | text | ||
| p16.1.8.3 | Position/Title | 0..1 | text | ||
| p16.1.8.4 | Responsibilities | 0..1 | text | ||
| p16.1.9 | Safety Oversight | 0..1 | text | ||
| p16.1.10 | Clinical Monitoring | 0..1 | text | ||
| p16.1.11 | Quality Assurance and Quality Control | 0..1 | text | ||
| p16.1.12 | Data Handling and Record Keeping | 0..1 | group | ||
| p16.1.12.1 | Data Quality Control and Reporting | 0..1 | text | ||
| p16.1.12.2 | Data Collection and Management Responsibilities | 0..1 | text | ||
| p16.1.12.3 | Data Archival | 0..1 | text | ||
| p16.1.12.4 | Study Records Retention | 0..1 | group | ||
| p16.1.12.4.1 | Photographs, Audio/Video Recordings Retention | 0..1 | text | ||
| p16.1.12.4.2 | Data and/or Biological Specimens Access | 0..1 | text | ||
| p16.1.12.4.3 | Data and/or Biological Specimens Retention/Banking | 0..1 | text | ||
| p16.1.13 | Protocol Deviations | 0..1 | text | ||
| p16.1.14 | Publication and Data Sharing Policy | 0..1 | text | ||
| p16.1.15 | Conflict of Interest Policy | 0..1 | text | ||
| p16.1.16 | Source Documents and Access to Source Data/Documents | 0..1 | text | ||
| p16.1.17 | Collections of Photographs, or Audio/Video Recording | 0..1 | text | ||
| p16.2 | Prior Approvals/Attachments Requiring Signatures | 0..1 | text | ||
| p16.3 | Additional Considerations | 0..1 | text | ||
| p16.4 | Abbreviations and Special Terms | 0..1 | text | ||
| p16.5 | Attachments | 0..* | text | ||
| p17 | STUDY ADMINISTRATION | 0..1 | group | ||
| p17.1 | Setting | 0..1 | group | ||
| p17.1.1 | Describe the sites / locations where your research team will conduct the research: | 0..1 | text | ||
| p17.2 | Registration | 0..1 | group | ||
| p17.2.1 | Describe the steps the research team will take to ensure that a participant is appropriately enrolled or registered in the study prior to receiving any study intervention (e.g. describe and submit any protocol eligibility checklist that will be used, specify who on the research team will confirm eligibility and that consent was documented, etc.): | 0..1 | text | ||
| p17.3 | Resources Available | 0..1 | group | ||
| p17.3.1 | Describe the roles/tasks of each research team member | 0..1 | text | ||
| p17.3.2 | Describe the qualifications (e.g., training, experience) of the PI and research team to perform their roles. Provide enough information for the IRB to determine the PI and research team are qualified to conduct the proposed research. Alternatively, you can submit the current CVs for the research team instead: | 0..1 | text | ||
| p17.3.3 | Describe the coverage plan to address any issues (including participant safety issues) that occur while the PI is away and/or unavailable. The research team member designated to serve as the acting PI in the PIabsence should have similar training and expertise as the PI: | 0..1 | text | ||
| p17.3.4 | Describe the process to ensure the research team members have adequate oversight and are adequately trained regarding the protocol, study procedures, and their roles and responsibilities: | 0..1 | text | ||
| p17.3.5 | Are medical or psychological resources that participants might need, such as for emergencies or medical issues, are available for the study? | 0..1 | choice | Options: 2 options | |
| p17.4 | IRB Review | 0..1 | group | ||
| p17.4.1 | An appropriate IRB , registered with the OHRP ,review and approve this study. | 0..1 | choice | Options: 2 options | |
| p17.4.2 | Any amendments to the protocol or informed consent documents will be reviewed and approved by the IRB prior to use, unless required to eliminate an apparent immediate hazard to participants? | 0..1 | choice | Options: 2 options | |
| p17.5 | Community-Based Participatory Research/Field Research | 0..1 | group | ||
| p17.5.1 | Can or will this study involve community-based participatory research? | 0..1 | choice | Definition: i336 Options: 2 options | |
| p17.5.2 | Community-based participatory research | 0..1 | group | Enable When: | |
| p17.5.2.1 | Describe the communities that will be involved in this research: | 0..1 | text | ||
| p17.5.2.2 | Describe the composition and involvement of any community advisory board: | 0..1 | text | ||
| p17.5.2.3 | Describe the involvement of the community in the design, protocol development, informed consent process, access to data and samples, and conduct of the research | 0..1 | text | ||
| p17.5.2.4 | Describe the plans on dissemination and publication of study results which are in agreement with the community: | 0..1 | text | ||
| p17.6 | Multi Site Research | 0..1 | group | ||
| p17.6.1 | Describe the plan for tracking IRB approval of documents and consent forms for each site: | 0..1 | text | ||
| p17.6.2 | Name of the sponsor and Contract Research Organization (CRO): | 0..1 | text | ||
| p17.6.3 | Describe the training that will be provided to the enrolling sites staff prior to protocol implementation at that study site and throughout the course of the study. Include the type of training, e.g., study meetings, teleconferences, etc., as well as who will provide the training and how it will be documented: | 0..1 | text | ||
| p17.6.4 | Describe the plan for ensuring that amendments to the Coordinating Center template protocol and template consent forms will be communicated to all sites: | 0..1 | text | ||
| p17.6.5 | Describe the plan for ensuring that all sites have the most current version of the protocol and consent forms: | 0..1 | text | ||
| p17.6.6 | Describe the plan for collection and management of data from all sites. Specify if data will be shared outside (e.g., with other investigators, sponsor, etc.) and how the data will be shared (e.g. how data will be received from and distributed to other sites as needed). If available, please provide the Data Sharing Plan or Policy: | 0..1 | text | ||
| p17.6.7 | Plan to manage and/or monitor each site's study conduct including enrollment, research events, withdrawals and protocol deviations: | 0..1 | group | ||
| p17.6.7.1 | Describe how the Coordinating Center will monitor each site's study conduct during the different phases of the study (e.g. remotely, in-person visits, reports, etc.): | 0..1 | text | ||
| p17.6.7.2 | Describe whether monitoring visits will be conducted. If so, how often? What will the site monitoring visits entail?: | 0..1 | text | ||
| p17.6.8 | Describe the plan for processing, reporting and evaluating unanticipated problems, protocol violations, deviations, and serious adverse events from all sites to the IRB, funder, and federal agencies (e.g. FDA): | 0..1 | text | ||
| p17.6.9 | Plan for handling of the investigational product (drug/device/biologic) at each site (if applicable): | 0..1 | group | ||
| p17.6.9.1 | Describe how they will be provided to each enrolling site: | 0..1 | text | ||
| p17.6.9.2 | Describe how dispensing will be monitored: | 0..1 | text | ||
| p17.6.9.3 | Describe what investigational product accountability procedures will be implemented: | 0..1 | text | ||
| p17.6.10 | Describe the procedures for study closures and early site termination: | 0..1 | text | ||
| p17.6.11 | Describe any collaborations not described above, such as [institution] investigators with multiple affiliations that would engage other institutions in research (e.g., [institution] is paying another institution for the research, the research is being conducted on behalf of another institution): | 0..1 | text | ||
| p17.7 | Key Roles and Study Governance | 0..1 | text | ||
| p18 | STUDY FINANCES | 0..1 | group | ||
| p18.1 | Funding Source | 0..1 | text | ||
| p18.2 | Costs to the participant | 0..1 | text | ||
| p18.3 | Participant Reimbursements or Payments | 0..1 | text | ||
| p18.4 | Compensation for Research-Related Injury | 0..1 | text | ||
| p19 | REFERENCES | 0..1 | text | ||
| ADMIN00 | Administrative Use Only | 0..1 | group |  | |
| ADMIN01 | Link ID prefix | 0..1 | string | | Initial Value: string = p |
| ADMIN02 | Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any | 0..1 | string | | Initial Value: string = temporarily unavailable |
| ADMIN03 | ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any | 0..1 | string | | Initial Value: string = temporarily unavailable |
| ADMIN04 | Questionnaire Response ID of the local considerations Questionnaire Response, if any | 0..1 | string | | |
| Documentation for this format | |||||
Option Sets
Answer options for p1.1
Answer options for p1.2
Answer options for p1.3
Answer options for p1.4
Answer options for p1.7
Answer options for p1.8.1
Answer options for p3.1.8
Answer options for p4.1.4
Answer options for p4.1.7
Answer options for p4.1.8.2
Answer options for p4.1.8.3
Answer options for p4.3.1.5
Answer options for p9.1.4
Answer options for p9.1.7.1
Answer options for p9.1.7.2.2
Answer options for p9.1.7.2.4
Answer options for p9.1.7.3
Answer options for p9.1.7.3.5
Answer options for p9.1.7.3.6
Answer options for p9.1.7.3.7
Answer options for p9.1.7.3.8
Answer options for p9.1.7.4
Answer options for p9.1.7.5.1
Answer options for p9.1.7.5.3.8
Answer options for p9.1.7.6
Answer options for p9.1.7.8
Answer options for p9.1.7.9.12
Answer options for p9.1.7.10
Answer options for p9.1.7.11.4
Answer options for p9.1.7.11.5
Answer options for p9.1.7.12
Answer options for p9.1.7.13.6
Answer options for p9.1.7.14
Answer options for p9.1.7.15.6
Answer options for p9.1.7.15.7.4
Answer options for p17.3.5
Answer options for p17.4.1
Answer options for p17.4.2
Answer options for p17.5.1
IG © 2020+ HL7 International - BR&R Work Group. Package hl7.fhir.us.sirb#0.1.0 based on FHIR 4.0.1. Generated 2021-08-10
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