Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use United States of America flag

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Questionnaire: Protocol Questionnaire

Official URL: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-protocol-questionnaire-populate Version: 1.0.0
Draft as of 2023-04-20 Computable Name: Protocol_questionnaire
Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. Protocol_questionnaireQuestionnairehttp://hl7.org/fhir/us/sirb/Questionnaire/sirb-protocol-questionnaire-populate#1.0.0
... p1Research Study0..1group
.... p1.1Study Type1..1choiceOptions: 2 options
Expressions:
  • Calculated Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding
..... p1.1_helpSelect the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)0..1display
.... p1.2Intervention1..1choiceEnable When: p1.1 = Interventional (Temporary Codes#INT)
Options: 4 options
..... p1.2_helpA 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..1display
.... p1.3Does this protocol require a FDA exemption?0..1choiceEnable When:
  • p1.2 = Drug/Biologic/Vaccine (Temporary Codes#DBV)
  • p1.2 = Device (Temporary Codes#DEV)

Options: 2 options
Expressions:
  • Calculated Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding
.... p1.30Is an IND or IDE being used in this study?0..1choiceEnable When: p1.3 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding
..... p1.30_helpIs an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?0..1display
.... p1.4Type of exemption0..1choiceEnable When: p1.3 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding
..... p1.4_helpSelect Investigational New Drug (IND) or Investigational Device Exemption (IDE)0..1display
.... p1.5Study Title0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.1').answer.value
..... p1.5_helpThe 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..1display
.... p1.6Study Title (Short)0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value
..... p1.6_helpA short study title written in language intended for the lay public.0..1display
.... p1.61Lead Principal Investigator0..1group
..... p1.61.1First Name0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value
...... p1.61.1_helpFirst or given name of the lead principal investigator0..1display
..... p1.61.2Last Name0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value
...... p1.61.2_helpSurname or family name0..1display
..... p1.61.7Suffix0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value
...... p1.61.7_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
..... p1.61.8Degree(s)0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value
...... p1.61.8_helpProfessional and Academic degrees of the lead principal investigator0..1display
..... p1.61.3Department Name0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.10').answer.value
..... p1.61.4Address0..1group
...... p1.61.4.1Street Address0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.1').answer.value
...... p1.61.4.2City0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.2').answer.value
...... p1.61.4.3State0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.3').answer.value
...... p1.61.4.4Zip Code0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.4').answer.value
...... p1.61.4.5Country0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.5').answer.value
..... p1.61.5Phone0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value
...... p1.61.5_help10-digit phone number, including area code0..1display
..... p1.61.6Email0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value
..... p1.61_helpThe 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.htm0..1display
.... p1.7Additional Investigator0..1choiceOptions: 2 options
..... p1.7_helpPerson(s) designated as the lead PI(s) for the multisite clinical trial; has the appropriate level of authority and responsibility to direct the research being conducted at all sites participating in the clinical trial.0..1display
.... p1.8Additional Investigator0..*groupEnable When: p1.7 = Yes (expandedYes-NoIndicator#Y)
..... p1.8.1Additional Investigator Role0..1open-choiceOptions: 3 options
..... p1.8.2First Name0..1string
...... p1.8.2_helpFirst or given name of the additional investigator0..1display
..... p1.8.3Last Name0..1string
...... p1.8.3_helpSurname or family name0..1display
..... p1.8.8Suffix0..1string
...... p1.8.8_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
..... p1.8.9Degree(s)0..1string
...... p1.8.9_helpProfessional and Academic degrees of the additional investigator0..1display
..... p1.8.4Department Name0..1string
..... p1.8.5Address0..1group
...... p1.8.5.1Street Address0..1string
...... p1.8.5.2City0..1string
...... p1.8.5.3State0..1string
...... p1.8.5.4Zip Code0..1string
...... p1.8.5.5Country0..1string
..... p1.8.6Phone0..1string
...... p1.8.6_help10-digit phone number, including area code0..1display
..... p1.8.7Email0..1string
.... p1.9IRB Protocol Number0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value
..... p1.9_helpProvided by the sIRB. Will not be available at the time of initial submission.0..1display
.... p1.10Sponsor Name(s) and Protocol Number0..1group
..... ExternalDataFor_p1.10.1.1External Data For linkId p1.10.1.10..*open-choiceiconExpressions:
  • Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value
..... p1.10.1Sponsor0..*group
...... p1.10.1.1Sponsor Name0..1open-choice
...... p1.10.1.2Sponsor Protocol Number0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.where(answer.valueString = %sponsorSelectedThisRepetition)).item.where(linkId = 'in5.4').answer.valueString
....... p1.10.1.2_helpUnique Protocol Identification Number used by the sponsor.0..1display
.... p1.11ClinicalTrials.Gov Identifier0..1string
..... p1.11_helpThe 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..1display
.... p1.12Grant Title0..1text
..... p1.12_helpFunding Opportunity Title0..1display
.... p1.13NIH Grant Number0..1text
.... p1.14IND Number0..1stringEnable When: p1.4 = IND (Temporary Codes#IND)
Expressions:
  • Calculated Value: iif(%typeExemptionIDEIDN = 'IND', %lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value)
.... p1.15IDE Number0..1stringEnable When: p1.4 = IDE (Temporary Codes#IDE)
Expressions:
  • Calculated Value: iif(%typeExemptionIDEIDN = 'IDE', %lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value)
.... p1.16Study Product Name0..1text
..... p1.16_helpGeneric, followed by marketed name if applicable0..1display
.... p1.17Study Product Provider0..1text
..... p1.17_helpe.g. NIH, or company0..1display
.... p1.18Funding Organization(s), Address and Contact Information0..1group
..... ExternalDataFor_p1.18.1.1External Data For linkId p1.18.1.10..*open-choiceiconExpressions:
  • Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value
..... p1.18.1Funding Organization0..*group
...... p1.18.1.1Name0..1open-choice
...... p1.18.1.2Address0..1group
....... p1.18.1.2.1Street Address0..1string
....... p1.18.1.2.2City0..1string
....... p1.18.1.2.3State0..1string
....... p1.18.1.2.4Zip Code0..1string
....... p1.18.1.2.5Country0..1string
...... p1.18.1.5Phone0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in5.2' and answer.value = %fundingOrgName)).item.where(linkId = 'in5.3').answer.value
....... p1.18.1.5_help10-digit phone number, including area code0..1display
...... p1.18.1.4Email0..1string
..... p1.18_helpe.g. NIH, or company0..1display
.... p1.19Sponsor(s), Address and Contact Information0..1group
..... ExternalDataFor_p1.19.1.1External Data For linkId p1.19.1.10..*open-choiceiconExpressions:
  • Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value
..... p1.19.1Sponsor0..*group
...... p1.19.1.1Name0..1open-choice
...... p1.19.1.2Department Name0..1string
...... p1.19.1.3Address0..1group
....... p1.19.1.3.1Street Address0..1string
....... p1.19.1.3.2City0..1string
....... p1.19.1.3.3State0..1string
....... p1.19.1.3.4Zip Code0..1string
....... p1.19.1.3.5Country0..1string
...... p1.19.1.4Email0..1string
...... p1.19.1.5Phone0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in5.2' and answer.value = %sponsorOrgNameSelectedThisRepetition)).item.where(linkId = 'in5.3').answer.value
....... p1.19.1.5_help10-digit phone number, including area code0..1display
..... p1.19_helpIndividual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization taking responsibility for and investing in a clinical investigation.0..1display
.... p1.20Medical Monitor0..1group
..... p1.20_helpMedical expert for the clinical trial0..1display
..... p1.20.1First Name0..1string
...... p1.20.1_helpFirst or given name of the medical monitor0..1display
..... p1.20.2Last Name0..1string
...... p1.20.2_helpSurname or family name0..1display
..... p1.20.6Suffix0..1string
...... p1.20.6_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
..... p1.20.7Degree(s)0..1string
...... p1.20.7_helpProfessional and Academic degrees of the medical monitor0..1display
..... p1.20.3Phone0..1string
...... p1.20.3_help10-digit phone number, including area code0..1display
..... p1.20.4Email0..1string
..... p1.20.5Address0..1group
...... p1.20.5.1Street Address0..1string
...... p1.20.5.2City0..1string
...... p1.20.5.3State0..1text
...... p1.20.5.4Zip Code0..1string
...... p1.20.5.5Country0..1string
.... p1.21Confidentialty Statement0..1text
.... p1.23Protocol Version Number0..1string
.... p1.24Protocol Version Date0..1date
... p2Protocol Amendment Summary of Changes Table0..*group
.... p2.1Affected Section(s)0..1text
.... p2.2Summary of Revisions Made0..1text
.... p2.3Rationale0..1text
... p2.4Statement of Compliance1..1textInitial Value: string = [Choose Sample Text] (1) [The trial will be carried out in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP) and the following: United 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 Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. In addition, all changes to the consent form 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.] OR (2) [The trial will be conducted in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and the <specify NIH Institute or Center (IC) > Terms and Conditions of Award. The Principal Investigator will assure that no deviation from, or changes to the protocol will take place without prior agreement from the Investigational New Drug (IND) or Investigational Device Exemption (IDE) sponsor, funding agency and documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study have completed Human Subjects 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 must be obtained before any participant is enrolled. 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 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_helpSelect one of the two statements below. If the study is an intramural NIH study, use the second statement below0..1display
... p3Protocol Summary0..1group
.... p3.1Synopsis0..1group
..... p3.1.1Title (Full)0..1stringExpressions:
  • Initial Value: %resource.item.item.where(linkId = 'p1.5').answer.value
..... p3.1.2Title (Short)0..1stringExpressions:
  • Initial Value: %resource.item.item.where(linkId = 'p1.6').answer.value
..... p3.1.3Study Description0..1text
...... p3.1.3_helpShort 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 included in the Schema and Schedule of Activities0..1display
..... p3.1.4Objectives0..1text
...... p3.1.4_helpInclude 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.gov0..1display
..... p3.1.5End Points0..1text
...... p3.1.5_helpPrimary endpoint and secondary endpoints.These endpoints should be the same as the endpoints contained in the body of the protocol. These align with Outcome Measures in clinicaltrials.gov0..1display
..... p3.1.6Accrual Ceiling/Number of Participants (projected-for all sites)0..1integer
...... p3.1.6_helpThe total number of subjects expected to complete the study. This includes expected sample size and estimated ineligible persons after signing a screening consent.0..1display
..... p3.1.7Study Population0..1text
...... p3.1.7_helpSpecify sample size, gender, age, demographic group, general health status, and geographic location.0..1display
..... p3.1.8Phase0..1choiceOptions: 3 options
...... p3.1.8_helpApplies to drugs and biologics.0..1display
..... p3.1.9Description of Sites/Facilities Enrolling Participants0..1text
...... p3.1.9_helpBrief 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..1display
..... p3.1.10Description of Study Intervention ( Agent/Procedure)/Investigational Product0..1text
...... p3.1.10_helpDescribe 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..1display
..... p3.1.11Study Duration0..1text
...... p3.1.11_helpEstimated time (in months) from when the study opens to enrollment until completion of data analyses0..1display
..... p3.1.12Participant Duration0..1text
...... p3.1.12_helpTime (e.g., in months) it will take for each individual participant to complete all participant visits.0..1display
..... p3.1.13Methodology0..1text
...... p3.1.13_helpDesign attributes such as single blind, double blind or open label; Randomized, placebo or active placebo control; cross-over design, etc.0..1display
..... p3.1.14Duration of Investigational Product Administration0..1textEnable When: p1.1 = Interventional (Temporary Codes#INT)
...... p3.1.14_helpTotal duration of investigational product administration (including any open-label lead-in, if applicable).0..1display
..... p3.1.15Key Procedures0..1text
...... p3.1.15_helpProcedures that are required for the study (e.g. harvesting of tumor, vaccine, tumor biopsy and blood draws)0..1display
..... p3.1.16Main Inclusion/Exclusion Criteria0..1text
...... p3.1.16_helpEntire list of inclusion and exclusion criteria will appear later in the protocol. Only include the key inclusion and exclusion criteria in this section.0..1display
..... p3.1.17Reference Therapy0..1textEnable When: p1.1 = Interventional (Temporary Codes#INT)
...... p3.1.17_helpNote if there is a standard reference therapy against which the investigational product is being compared, or if the reference is a placebo0..1display
..... p3.1.18Statistical Analysis0..1text
...... p3.1.18_helpA 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..1display
.... p3.2Schema0..1group
..... p3.2.1Attach schema here0..1attachment
..... p3.2_helpThis section is optional. If a schematic is used, it should provide a quick "snapshot" of the study and ideally be limited to one page. Please see the NIH Protocol Templates for Clinical Trials page for the protocol template which contains examples of schematics. A schematic shows the level of detail needed to convey an overview of study design with study-specific information about the 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, the Study Schedule, e.g., Visit 1, Day 0; Visit 2, Day 30 +/- 7; etc.0..1display
.... p3.3Schedule of Activities0..1group
..... p3.3.1Schedule of Activities0..1text
...... p3.3.1_helpDescribe the schedule of activities in the text box here or attach a copy of the Schedule of Activities below.0..1display
..... p3.3.3Schedule of Activities Attachment0..1group
...... p3.3.3.1Describe the file that is being attached (optional)0..1string
...... p3.3.3.2Attachment0..1attachment
..... p3.3_helpThe 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. Either describe in the text box here or attach a copy of the Schedule of Activities.0..1display
... p4Introduction, Background Information and Scientific Rational0..1group
.... p4.1Background0..1group
..... p4.1.1Describe the relevant literature and the specific gaps in current knowledge that this study intends to address0..1text
...... p4.1.1_helpGaps that this study intends to address based on literature0..1display
..... p4.1.2Provide 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 knowledge0..1text
...... p4.1.2_helpBased on the existing literature and how it will add to existing knowledge0..1display
..... p4.1.3Describe the relevance and usefulness of the objectives0..1text
..... p4.1.4Is this the first time the study drug, device, or intervention/procedure will be used in humans.0..1choiceOptions: 2 options
..... p4.1.5If there has been experience with the study drug, device, or intervention/procedure in humans, detail the experience to date0..1textEnable When: p4.1.4 = No (expandedYes-NoIndicator#N)
...... p4.1.5_helpDetails If the intervention/drug/device is not the first time used.0..1display
..... p4.1.6Investigational Product0..1groupEnable When: p1.1 = Interventional (Temporary Codes#INT)
...... p4.1.6_helpIn 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..1display
...... p4.1.6.1Name and Description0..1text
...... p4.1.6.2Preclinical Data0..1text
...... p4.1.6.3Clinical Data to Date0..1group
....... p4.1.6.3.1Human Pharmacokinetics0..1text
....... p4.1.6.3.2Clinical Studies in adults0..1text
....... p4.1.6.3.3Clinical Studies in Children0..1text
..... p4.1.7Is there an active control group?0..1choiceOptions: 2 options
..... p4.1.8Active Control Group0..1groupEnable When: p4.1.7 = Yes (expandedYes-NoIndicator#Y)
...... p4.1.8.1Describe 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 treatment0..1text
...... p4.1.8.2Is 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..1choiceOptions: 2 options
...... p4.1.8.3Is the active control an established effective intervention?0..1choiceOptions: 2 options
...... p4.1.8.4If no, clarify how it is ethically justified to use this control in the study0..1textEnable When: p4.1.8.3 = No (expandedYes-NoIndicator#N)
.... p4.2Study Rationale0..1text
..... p4.2_helpThe 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..1display
.... p4.3Risk/Benefit Assessment0..1group
..... p4.3.1Potential Risks0..1group
...... p4.3.1.1List 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 risks0..1text
...... p4.3.1.2State which study interventions may have unknown risks0..1text
...... p4.3.1.3State 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 participant0..1text
...... p4.3.1.4Describe risks to people other than the participating participant, e.g., risks to family members, friends, others or risks to the community0..1text
...... p4.3.1.5Are 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..1choiceOptions: 2 options
...... p4.3.1.6Risks 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..1groupEnable When: p4.3.1.5 = Yes (expandedYes-NoIndicator#Y)
....... p4.3.1.6.1Describe these risks0..1text
....... p4.3.1.6.2Describe the procedures that will be put in place to minimize these risks0..1text
....... p4.3.1.6.3Describe how these procedures are adequate for the location where study procedures will be performed0..1text
...... p4.3.1.7Other risks0..1text
..... p4.3.2Potential Benefits0..1group
...... p4.3.2.1Describe the potential benefits that individual participants may experience from taking part in the research. Include the probability, magnitude, and duration of the potential benefits0..1text
....... p4.3.2.1_helpNote: Payments and incentives are not considered benbefits.0..1display
...... p4.3.2.2Describe any benefit to the population from which the participant is drawn0..1text
...... p4.3.2.3Describe any benefit to science, society, and humanity in general0..1text
...... p4.3.2.4Other benefits0..1text
..... p4.3.3Alternatives to Study Participation0..1group
...... p4.3.3.1Describe alternatives to participating in this research study (e.g. to decide not participate in the study, alternative treatments, no treatment (palliative care), etc.)0..1text
...... p4.3.3.2Describe the standard clinical care that may be an alternative0..1text
...... p4.3.3.3Describe how the participant can receive the research procedures/drug/device used in this study in a non-research setting0..1text
...... p4.3.3.4Other alternatives to study participation0..1text
... p5Study Purpose, Objectives or Specific Aims0..1group
.... p5_helpDescribe the purpose, specific aims, or objectives of the study0..1display
.... p5.1Hypothesis0..1text
.... p5.2Primary Objectives0..1text
..... p5.2_helpThe main question the study seeks to answer.0..1display
.... p5.3Secondary Objectives0..1text
..... p5.3_helpThe secondary objective(s) are goals that will provide further information on the use of the intervention.0..1display
.... p5.4Tertiary/Exploratory Objectives0..1text
..... p5.4_helpTertiary/exploratory objective(s) serve as a basis for explaining or supporting findings of primary analyses and for suggesting further hypotheses for later research.0..1display
... p6Study Endpoints0..1group
.... p6_helpPrecise definitions of the study endpoints and criteria for evaluation0..1display
.... p6.1Primary Endpoints0..1text
..... p6.1_helpDescription of primary endpoints identified in the primary Study Protocol.0..1display
..... p6.1.1Justification for Endpoints0..1text
...... p6.1.1_helpBriefly explain why the endpoint(s) were chosen.0..1display
.... p6.2Secondary Endpoints0..1text
..... p6.2.1Justification for Secondary Endpoints0..1text
...... p6.2.1_helpBriefly explain why the endpoint(s) were chosen.0..1display
.... p6.3Tertiary Endpoints0..1text
..... p6.3_helpExploratory 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..1display
..... p6.3.1Justification for Tertiary Endpoints0..1text
...... p6.3.1_helpBriefly explain why the endpoint(s) were chosen.0..1display
.... p6.4Primary Safety endpoints0..1text
.... p6.5Secondary Safety endpoints0..1text
.... p6.6Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims.0..1text
... p7Study Design0..1group
.... p7.1Overall Design0..1text
..... p7.1_helpThe 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..1display
.... p7.2Scientific Rationale for Study Design0..1text
..... p7.2_helpDescribe 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..1display
.... p7.3Justification for Dose0..1textEnable When: p1.2 = Drug/Biologic/Vaccine (Temporary Codes#DBV)
.... p7.4Justification for Intervention0..1textEnable When: p1.1 = Interventional (Temporary Codes#INT)
..... p7.4_helpProvide 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..1display
.... p7.5End of Study Definition0..1text
..... p7.5_helpA clinical trial is considered completed when participants are no longer being examined or the last participant's last study visit has occurred.0..1display
.... p7.6Screening Activities0..1text
.... p7.7Study Intervention Activities0..1text
.... p7.8Follow Up Activities0..1text
.... p7.9Allocation to Interventional Group0..1text
.... p7.10Study/Data Collection Instruments0..1text
.... p7.11Research Setting0..1text
.... p7.15Study Design Attachments0..*group
..... p7.15_helpAttach documents related to the Study Design here such as Study Intervention Activities descriptions, Follow Up plans and Study/Data Collection Instruments0..1display
..... p7.15.1Describe the file that is being attached0..1string
..... p7.15.2Attachment0..1attachment
... p8Study Population0..1group
.... p8.1Participant Selection0..1group
..... p8.1.1Category/Group (eg. Adults, controls, parents, children)0..1text
..... p8.1.2Age Range0..1text
..... p8.1.3Maximum Number to be Consented or Reviewed/Collected(include withdrawals and screen failures)0..1integer
..... p8.1.4Number Expected to Complete the Study or Needed to Address the Research Question0..1integer
..... p8.1.5Total Number of participants0..1integer
..... p8.1.6Overall study sample size (if multisite)0..1integer
... p9Study Enrollment and Withdrawal0..1group
.... p9.1Eligibility Criteria0..1group
..... p9.1.1Inclusion and Exclusion Criteria0..1group
...... p9.1.1.1Inclusion Criteria0..*text
....... p9.1.1.1_helpDescription of criteria that define participants to include in study0..1display
...... p9.1.1.2Exclusion Criteria0..*text
....... p9.1.1.2_helpDescription of criteria that define participants to exclude in study0..1display
..... p9.1.2Describe in detail how the eligibility criteria will be assessed and satisfied (e.g., medical record review, physical examination)0..1text
..... p9.1.3State 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 study0..1text
..... p9.1.4Can study participants participate in another research study while participating in this research study0..1choiceOptions: 2 options
..... p9.1.5Screen Failures0..1text
...... p9.1.5_helpParticipants 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..1display
..... p9.1.6Lifestyle Considerations0..1text
...... p9.1.6_helpDescribe 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..1display
..... p9.1.7Vulnerable Populations0..1group
...... p9.1.7.1Can or will pregnant women be enrolled0..1choiceOptions: 2 options
...... p9.1.7.2Enrollment of Pregnant Women0..1groupEnable When: p9.1.7.1 = Yes (expandedYes-NoIndicator#Y)
....... p9.1.7.2.1Describe 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 fetuses0..1text
....... p9.1.7.2.2Are there any risk to the fetus from the study interventions or procedures.0..1choiceOptions: 2 options
....... p9.1.7.2.3Risks to Fetus0..1textEnable When: p9.1.7.2.2 = Yes (expandedYes-NoIndicator#Y)
....... p9.1.7.2.4Do the study interventions or procedures hold out the prospect of direct benefit for the woman or the fetus0..1choiceOptions: 2 options
....... p9.1.7.2.5Describe benefit for the women or fetus0..1textEnable When: p9.1.7.2.4 = Yes (expandedYes-NoIndicator#Y)
....... p9.1.7.2.6If 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 means0..1textEnable When: p9.1.7.2.4 = No (expandedYes-NoIndicator#N)
....... p9.1.7.2.7Describe the biomedical knowledge that is expected to result from this research for this population0..1text
....... p9.1.7.2.8Describe how any risk of this research is the least possible for achieving the objectives of the research0..1text
....... p9.1.7.2.9Describe how mothers providing consent are informed of the reasonably foreseeable impact of the research on the fetus or neonate0..1text
...... p9.1.7.3Can or will the research involve neonates of uncertain viability or non-viable neonates?0..1choiceOptions: 2 options
...... p9.1.7.31Research involving neonates of uncertain viability or non-viable neonates0..1groupEnable When: p9.1.7.3 = Yes (expandedYes-NoIndicator#Y)
....... p9.1.7.31.1Describe any preclinical and clinical studies that have been conducted that provide data for assessing potential risks to neonates0..1text
....... p9.1.7.31.2Describe the important biomedical knowledge that will be developed from this research and why it cannot be obtained by other means0..1text
....... p9.1.7.31.3Describe whether there will be added risk to the neonate resulting from the research0..1text
....... p9.1.7.31.4Describe how individuals providing consent are informed of the reasonably foreseeable impact of the research on the neonate0..1text
....... p9.1.7.31.5No 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 study0..1choiceOptions: 2 options
....... p9.1.7.31.6Individuals engaged in the research will have no part in determining the viability of a neonate0..1choiceOptions: 2 options
....... p9.1.7.31.7For 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 neonate0..1choiceOptions: 2 options
....... p9.1.7.31.8For 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 objective0..1choiceOptions: 2 options
...... p9.1.7.4Can or will participants who are not yet adults (neonates, children, teenagers) be enrolled?0..1choiceOptions: 2 options
...... p9.1.7.5Enrollment of participants who are not yet adults (neonates, children, teenagers)0..1groupEnable When: p9.1.7.4 = Yes (expandedYes-NoIndicator#Y)
....... p9.1.7.5.1I 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..1choiceOptions: 2 options
........ p9.1.7.5.1.1If this SOP will not be followed, describe how this (attainment of legal age for consent or not) will be determined0..1text
....... p9.1.7.5.2Describe how permission to participate in the study will be obtained from the parents or legal guardians0..1text
....... p9.1.7.5.3Assent process of children0..1group
........ p9.1.7.5.3.1Describe waiting period between informing the prospective participant and obtaining the assent0..1text
........ p9.1.7.5.3.2Describe any process to ensure ongoing assent0..1text
........ p9.1.7.5.3.3Describe Research team members involved in the assent process0..1text
........ p9.1.7.5.3.4Describe how long children will have to consider study participation0..1text
........ p9.1.7.5.3.5Describe steps that will be taken to minimize the possibility of coercion or undue influence0..1text
........ p9.1.7.5.3.6Describe steps that will be taken to ensure the participants's understanding0..1text
........ p9.1.7.5.3.7If assent will not be obtained from children, specify why0..1text
........ p9.1.7.5.3.8Will children reach 18 years of age while in the study?0..1choiceOptions: 2 options
........ p9.1.7.5.3.9Children reaching 18 years of age while in the study0..1groupEnable When: p9.1.7.5.3.8 = Yes (expandedYes-NoIndicator#Y)
......... p9.1.7.5.3.9.1Describe the plan to obtain written informed consent from the participant at age 18 years0..1text
......... p9.1.7.5.3.9.2Describe who will be responsible for managing the plan0..1text
......... p9.1.7.5.3.9.3Describe where the consent discussion will take place0..1text
......... p9.1.7.5.3.9.4Describe what will happen if the participant cannot be located to provide consent at age 18 years0..1text
...... p9.1.7.6Can 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..1choiceOptions: 2 options
...... p9.1.7.7Enrollment 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..1groupEnable When: p9.1.7.6 = Yes (expandedYes-NoIndicator#Y)
....... p9.1.7.7.1Describe 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 appropriate0..1text
....... p9.1.7.7.2Describe how informed consent will be executed with this population in a way that allows for independent and thoughtful decision-making0..1text
....... p9.1.7.7.3Describe any additional steps or procedures that will be used when performing informed consent with this population0..1text
...... p9.1.7.8Can or will cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent be enrolled?0..1choiceOptions: 2 options
...... p9.1.7.9Enrollment of cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent0..1groupEnable When: p9.1.7.8 = Yes (expandedYes-NoIndicator#Y)
....... p9.1.7.9.1Describe whether the research holds out a prospect of direct benefit to the individual participant that is unavailable outside the research context0..1text
....... p9.1.7.9.2Describe why the objectives of the study cannot be met by enrolling participants who are able to give consent0..1text
....... p9.1.7.9.4Describe the process to determine whether or not the individual is capable of consent0..1text
....... p9.1.7.9.5Describe who will determine if the participant is able to provide informed consent0..1text
....... p9.1.7.9.6Describe how it will be determined whether the participant is able to provide informed consent0..1text
....... p9.1.7.9.7Describe when and how often (even after obtaining informed consent) it will be determined whether the participant is able to provide informed consent0..1text
....... p9.1.7.9.8List 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..1text
....... p9.1.7.9.9If 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 consent0..1text
....... p9.1.7.9.10Process for assent of participants0..1group
........ p9.1.7.9.10.1Describe 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 not0..1text
........ p9.1.7.9.10.2If assent will not be obtained from some or all participants, an explanation of why not0..1text
........ p9.1.7.9.10.3Describe 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 documents0..1text
....... p9.1.7.9.11Provide a description of how the patient will be informed of the potential risks and benefits of the study and any procedures associated with its use0..1text
....... p9.1.7.9.12Participants will be withdrawn if they appear to be unduly distressed at any time during the study.0..1choiceOptions: 2 options
...... p9.1.7.10Can or will prisoners be enrolled?0..1choiceOptions: 2 options
...... p9.1.7.11Enrollment of prisoners0..1groupEnable When: p9.1.7.10 = Yes (expandedYes-NoIndicator#Y)
....... p9.1.7.11.1Describe 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 impaired0..1text
....... p9.1.7.11.2Describe whether the risks involved in the research are commensurate with risks that would be accepted by non-Prisoner volunteers0..1text
....... p9.1.7.11.3Describe 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 project0..1text
....... p9.1.7.11.4Parole 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..1choiceOptions: 2 options
....... p9.1.7.11.6If 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 fact0..1text
...... p9.1.7.12Can or will students and/or employees be enrolled in this research?0..1choiceOptions: 2 options
...... p9.1.7.13Enrollment of students and/or employees0..1groupEnable When: p9.1.7.12 = Yes (expandedYes-NoIndicator#Y)
....... p9.1.7.13.1Describe the justification for specifically targeting recruitment efforts to enroll students and/or employees0..1text
....... p9.1.7.13.2Describe how potential coercion will be eliminated0..1text
....... p9.1.7.13.3Describe 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 that0..1text
....... p9.1.7.13.4Describe additional safeguards included to protect the rights and welfare of students and employees0..1text
....... p9.1.7.13.5Describe 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 employee0..1text
....... p9.1.7.13.6Submitted 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..1choiceOptions: 2 options
...... p9.1.7.14Can 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..1choiceOptions: 2 options
...... p9.1.7.15Enrollment 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..1groupEnable When: p9.1.7.14 = Yes (expandedYes-NoIndicator#Y)
....... p9.1.7.15.1Describe the justification for recruiting and enrolling this population0..1text
....... p9.1.7.15.2Describe 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 that0..1text
....... p9.1.7.15.3Describe 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 that0..1text
....... p9.1.7.15.4Describe how it will be ensured that the appropriate person(s) grants permission for each ward to participate in the research0..1text
....... p9.1.7.15.5Describe 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 guardian0..1text
....... p9.1.7.15.6Is the study is greater than minimal risk?0..1choiceOptions: 2 options
....... p9.1.7.15.7Greater than minimal risk study0..1groupEnable When: p9.1.7.15.6 = Yes (expandedYes-NoIndicator#Y)
........ p9.1.7.15.7.1Describe 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 wards0..1text
........ p9.1.7.15.7.2Describe 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 parentis0..1text
........ p9.1.7.15.7.3Describe the background and experience of the advocate to act in the best interests of the child for the duration of the childparticipation in the research0..1text
........ p9.1.7.15.7.4The 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..1choiceOptions: 2 options
.... p9.2Strategies for Recruitment and Retention0..1group
..... p9.2.1Recruitment Methods0..1group
...... p9.2.1.1Describe when, where, and how potential participants will be recruited0..1text
....... p9.2.1.1_helpProvide a broad overview of the recruitment activities. Specific media, content, duration and scripts will be gathered on the Recruitment Materials Questionnaire.0..1display
...... p9.2.1.2When participants respond to recruitment material, describe the information that will be collected from participants (e.g. name, telephone number, etc.).0..1text
...... p9.2.1.3Describe source of participants (for example, patient population, local community, etc.)0..1text
...... p9.2.1.4Describe methods that will be used to identify potential participants0..1text
...... p9.2.1.5Describe how the recruitment methods described will be effective in attracting the targeted participant population0..1text
.... p9.3Duration of Study Participation (If there are sub-studies, include duration of participation in each sub-study.)0..1text
... p10Study Intervention0..1groupEnable When: p1.1 = Interventional (Temporary Codes#INT)
.... p10.1Study Agent0..1group
..... p10.1.1Study Agent and Control Description0..1text
..... p10.1.2Receipts/Acquisition0..1text
...... p10.1.2_helpState 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..1display
..... p10.1.3Study Agent Accountability/ Return or Destruction of Investigational Product0..1text
...... p10.1.3_helpDescribe 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..1display
..... p10.1.4Formulation and appearance of Control Product0..1text
...... p10.1.4_helpDescribe the formulation and appearance the study intervention. This section should include the name of the manufacturer of the control product.0..1display
..... p10.1.5Formulation and appearance of Test Product0..1text
...... p10.1.5_helpDescribe the formulation and appearance the study intervention. This section should include the name of the manufacturer of the control product.0..1display
..... p10.1.6Packaging and Labeling0..1text
...... p10.1.6_helpDescribe 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..1display
..... p10.1.7Product Storage and Stability0..1text
...... p10.1.7_helpDescribe 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..1display
..... p10.1.8Preparation0..1text
...... p10.1.8_helpDescription of 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, as appropriate. For devices, include any relevant assembly or use instructions.0..1display
..... p10.1.9Administration and/or Dosing0..1text
...... p10.1.9_helpDescribe 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..1display
..... p10.1.10Route of Administration0..1text
..... p10.1.11Starting Dose and Dose Escalation Schedule0..1text
...... p10.1.11_helpState 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..1display
..... p10.1.12Dose Adjustments/Modifications/Delays0..1text
..... p10.1.13Duration of Therapy0..1text
..... p10.1.14Tracking Dose0..1text
..... p10.1.15Device Specific Considerations0..1text
..... p10.1.16Administration Instructions0..1text
..... p10.1.17Dispensing [authority, requirements]0..1text
..... p10.1.18Supply of Study Drug at the Site0..1text
.... p10.2Study Behavioral or Social Intervention(s)0..1groupEnable When: p1.2 = Social/Behavioral/educational (SBE) (Temporary Codes#SBE)
..... p10.2.1Administration of Intervention0..1text
..... p10.2.2Procedures for Training Interventionalists and Monitoring Intervention Fidelity0..1text
..... p10.2.3Assessment of participant Compliance with Study Intervention0..1text
.... p10.3Study Procedural Intervention(s) Description0..1group
..... p10.3.1Administration of Procedural Intervention0..1text
..... p10.3.2Procedures for Training of Clinicians on Procedural Intervention0..1text
..... p10.3.3Assessment of Clinician and/or Participant Compliance with Study Procedural Intervention0..1text
...... p10.3.3_helpDefine 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..1display
.... p10.4Participant Compliance and Monitoring0..1text
.... p10.5Study Intervention/Experimental Manipulation Adherence0..1text
... p11Study Intervention Discontinuation and Participant Discontinuation/Withdrawal0..1group
.... p11.1Discontinuation of Study Intervention0..1text
..... p11.1_helpParticipants 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). A Case Report Form (CRF) should capture the date and the specific underlying reason for discontinuation of study intervention or participant discontinuation/withdrawal.0..1display
.... p11.2Participant withdrawal and Termination0..1group
..... p11.2.1Reasons for Withdrawal or Termination0..1text
..... p11.2.2Handling of Participant Withdrawal or Termination0..1text
..... p11.2.3Replacement of participants0..1text
.... p11.3Lost to Follow-Up0..1text
..... p11.3_helpThe protocol should describe the nature and duration of study follow-up. 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..1display
... p12Study Procedures0..1group
.... p12.1Study Procedures/Evaluations0..1group
..... p12.1.1Study Specific Procedures0..1text
..... p12.1.2Standard of Care Study Procedures0..1text
.... p12.2Laboratory Procedures/Evaluations0..1group
..... p12.2.1Clinical Laboratory Evaluations0..1text
..... p12.2.2Research Laboratory Evaluations0..1text
..... p12.2.3Other Assays or Procedures0..1text
..... p12.2.4Specimen Preparation, Handling, and Storage0..1text
..... p12.2.5Specimen Shipment0..1text
.... p12.3Data Collection and Follow Up for Withdrawn participants0..1text
.... p12.4Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception).0..1text
.... p12.5Precautionary Medications, Treatments, and Procedures0..1text
.... p12.6Prohibited Medications, Treatments, and Procedures0..1text
.... p12.7Prophylactic Medications, Treatments, and Procedures0..1text
.... p12.8Rescue Medications, Treatments, and Procedures0..1text
..... p12.8_helpList 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..1display
.... p12.9Participant Access to Study Agent at Study Closure0..1text
.... p12.10Concomitant Medications, Treatments , and Procedures0..1text
..... p12.10_helpThis 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..1display
... p13Schedule of Study Procedures0..1group
.... p13.1Screening0..1text
.... p13.2Enrollment/Visit 1/Baseline Visit0..1text
.... p13.3Intermediate Visits0..*text
.... p13.4Final Study Visit0..1text
.... p13.5Withdrawal/Early Termination Visit0..1text
.... p13.6Unscheduled Visit0..1text
.... p13.7Follow Up Phase of the Study0..1group
..... p13.7.1Visit0..*text
..... p13.7.2End of Study Visit0..1text
.... p13.15Schedule of Study Procedures Attachments0..*group
..... p13.15_helpAttachments regarding the Schedule of Study Procedures can be attached here.0..1display
..... p13.15.1Describe the file that is being attached (optional)0..1string
..... p13.15.2Attachment0..1attachment
... p14Assessment of Safety0..1group
.... p14_helpAssessments related to safety and the aspects of the study which are proposed to ensure the safety of trial participants, 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..1display
.... p14.1Specification of Safety Parameters0..1group
..... p14.1.1Definition of Adverse Events(AE)0..1text
...... p14.1.1_helpProvide the definition of an AE being used for the clinical trial.0..1display
..... p14.1.2Definition of Serious Adverse Events (SAE)0..1text
...... p14.1.2_helpProvide the definition of an SAE being used for the clinical trial.0..1display
..... p14.1.3Definition of Unanticipated Problems0..1text
...... p14.1.3_helpThis includes any incident or outcome that is not expected in terms of nature, frequency, or severity related to the research procedures and participants.0..1display
.... p14.2Classification of an Adverse Event0..1group
..... p14.2.1Severity of an Event0..1text
...... p14.2.1_helpAll AEs are 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.0..1display
..... p14.2.2Relationship to Study Intervention/Experimental Manipulation0..1text
...... p14.2.2_helpDescription of 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.0..1display
..... p14.2.3Expectedness0..1text
...... p14.2.3_helpDescription of an adverse event, the nature or severity is not in Investigator Brochure or has been observed, or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere0..1display
.... p14.3Time Period and Frequencey for Event Assessment and Follow-Up0..1text
.... p14.4Reporting Procedures0..1group
..... p14.4.1Notifying the IRB0..1group
...... p14.4.1.1Adverse Event Reporting0..1text
....... p14.4.1.1_helpDescription of the AE reporting procedures, including timeframes0..1display
...... p14.4.1.2Serious Adverse Event Reporting0..1text
....... p14.4.1.2_helpDescription of the SAE reporting procedures, including timeframes0..1display
...... p14.4.1.3Unanticipated Problem Reporting0..1text
....... p14.4.1.3_helpThis 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..1display
...... p14.4.1.4Reporting of Pregnancy0..1text
....... p14.4.1.4_helpState 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..1display
..... p14.4.2Notifyiing the Study Sponsor0..1text
..... p14.4.3Notifying the FDA0..1text
..... p14.4.4Notifying Participating Investigators0..1text
..... p14.4.5Reporting Events to Participants0..1text
...... p14.4.5_helpDescribe 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 procedures0..1display
..... p14.4.6Events of Special Interest0..1text
...... p14.4.6_helpDescribe 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..1display
.... p14.5Follow Up Report0..1text
.... p14.6Study Halting/Stopping Rules0..1text
... p15Statistical Considerations0..1group
.... p15.1Statistical and Analytical Plans(SAP)0..1text
.... p15.2Statistical Hypotheses0..1text
..... p15.2_helpState 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..1display
.... p15.3Analysis Datasets0..1text
..... p15.3_helpClearly identify and describe the analysis datasets (e.g., which participants will be included in each).0..1display
.... p15.4Populations for Analysis0..1text
.... p15.5Sample Size Determination0..1text
..... p15.5_helpInclude 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 and judge the feasibility of enrolling and following the necessary number of participants. 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..1display
.... p15.6Description of Statistical Methods0..1group
..... p15.6.1General Approach0..1text
..... p15.6.2Analysis of Primary Efficacy Endpoints(s)0..1text
..... p15.6.3Analysis of Secondary Endpoint(s)0..1text
..... p15.6.4Safety Analyses0..1text
...... p15.6.4_helpDescribe how safety endpoints will be analyzed (e.g., as summary statistics during treatment and/or as change scores from baselines such as shift tables). The information included here should be consistent with the information contained within Assessment of Safety section.0..1display
..... p15.6.5Adherence and Retention Analyses0..1text
..... p15.6.6Baseline Descriptive Statistics0..1text
..... p15.6.7Planned Interim Analyses0..1group
...... p15.6.7.1Safety Review0..1text
...... p15.6.7.2Efficacy Review0..1text
..... p15.6.8Additional Sub-Group Analyses0..1text
..... p15.6.9Multiple Comparison/Multiplicity0..1text
..... p15.6.10Tabulation of Individual Response Data0..1text
..... p15.6.11Exploratory Analyses0..1text
..... p15.6.12Pharmacokinetic Analysis (if applicable)0..1text
.... p15.7Sample Size0..1text
..... p15.7_helpInclude 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..1display
.... p15.8Measures to Minimize Bias0..1group
..... p15.8.1Enrollment/Randomization/Masking Procedures0..1text
..... p15.8.2Evaluation of Success of Blinding0..1text
..... p15.8.3Breaking the Study Blind/Participant Code0..1text
... p16Supporting Documentation and Operational Considerations0..1group
.... p16.1Regulatory, Ethical and Study Oversight Considerations0..1group
..... p16.1.1Protocol Amendments0..1text
..... p16.1.2Ethical Standard0..1text
..... p16.1.3Institutional Review Board0..1text
..... p16.1.4Informed Consent Process0..1group
...... p16.1.4.1Consent/Assent and Other Informational Documents Provided to Participants0..1text
...... p16.1.4.2Consent Procedures and Documentation0..1group
....... p16.1.4.2.1Specify how the research team will assure that participants have sufficient time to consider whether to participate in the research0..1text
....... p16.1.4.2.2Describe the parental permission process and the child assent process. (If study involves children)0..1text
....... p16.1.4.2.3Some 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 individuals0..1text
....... p16.1.4.2.4Methods of Informed Consent for non-English Speakers0..1text
....... p16.1.4.2.5Waiver or Alteration of Consent Process0..1text
....... p16.1.4.2.6HIPAA Authorization0..1group
........ p16.1.4.2.6.1Participant's Capacity to Give Legally Effective Consent0..1text
...... p16.1.4.3Indicate where the consent process will take place.0..1text
..... p16.1.5Participant data and Confidentialty0..1group
...... p16.1.5.1Research Use of Stored Human Samples, Specimens, or Data0..1text
...... p16.1.5.2Confidentiality of Research Biospeciemen/Data0..1text
...... p16.1.5.3Certificate of Confidentiality (if applicable)0..1text
...... p16.1.5.4Provisions to Protect the Privacy of Participants0..1text
..... p16.1.6Future Use of Stored Human Specimens and Data0..1text
..... p16.1.7Study Discontinuation and Closure0..1text
..... p16.1.8Key Roles and Expertise of Study Team0..*group
...... p16.1.8.1First Name0..1string
....... p16.1.8.1_helpFirst or given name0..1display
...... p16.1.8.2Last Name0..1string
....... p16.1.8.2_helpSurname or family name0..1display
...... p16.1.8.3Position/Title0..1string
...... p16.1.8.4Responsibilities0..1text
...... p16.1.8_helpProvide 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..1display
..... p16.1.9Safety Oversight0..1text
..... p16.1.10Clinical Monitoring0..1text
..... p16.1.11Quality Assurance and Quality Control0..1text
..... p16.1.12Data Handling and Record Keeping0..1group
...... p16.1.12.1Data Quality Control and Reporting0..1text
...... p16.1.12.2Data Collection and Management Responsibilities0..1text
...... p16.1.12.3Data Archival0..1text
...... p16.1.12.4Study Records Retention0..1group
....... p16.1.12.4.1Photographs, Audio/Video Recordings Retention0..1text
....... p16.1.12.4.2Data and/or Biological Specimens Access0..1text
....... p16.1.12.4.3Data and/or Biological Specimens Retention/Banking0..1text
..... p16.1.13Protocol Deviations0..1text
..... p16.1.14Publication and Data Sharing Policy0..1text
..... p16.1.15Conflict of Interest Policy0..1text
..... p16.1.16Source Documents and Access to Source Data/Documents0..1text
..... p16.1.17Collections of Photographs, or Audio/Video Recording0..1text
.... p16.2Prior Approvals/Attachments Requiring Signatures0..1group
..... p16.2.1Prior Approvals/Attachments Requiring Signatures0..1text
..... p16.2.2Attachment0..1attachment
...... p16.2.2_helpAttach any prior approvals or documents requiring signatures0..1display
.... p16.3Additional Considerations0..1text
.... p16.4Abbreviations and Special Terms0..1text
.... p16.5Other Supporting Documentation and Operational Considerations Attachments0..*group
..... p16.5.1Describe the file that is being attached (optional)0..1string
..... p16.5.2Attachment0..1attachment
...... p16.5.2_helpOther supporting documentation or operational consideration documentation can be attached here, if relevant0..1display
... p17Study Administration0..1group
.... p17.1Setting0..1group
..... p17.1.1Describe the sites / locations where your research team will conduct the research0..1text
.... p17.2Registration0..1group
..... p17.2.1Describe 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..1text
.... p17.3Resources Available0..1group
..... p17.3.1Describe the roles/tasks of each research team member0..1text
..... p17.3.2Describe 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 instead0..1text
..... p17.3.3Describe 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 PI0..1text
..... p17.3.4Describe the process to ensure the research team members have adequate oversight and are adequately trained regarding the protocol, study procedures, and their roles and responsibilities0..1text
..... p17.3.5Are medical or psychological resources that participants might need, such as for emergencies or medical issues, are available for the study?0..1choiceOptions: 2 options
.... p17.4IRB Review0..1group
..... p17.4.1An appropriate IRB , registered with the OHRP ,review and approve this study.0..1choiceOptions: 2 options
..... p17.4.2Any 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..1choiceOptions: 2 options
.... p17.5Community-Based Participatory Research/Field Research0..1group
..... p17.5.1Can or will this study involve community-based participatory research?0..1choiceOptions: 2 options
..... p17.5.2Community-based participatory research0..1groupEnable When: p17.5.1 = Yes (expandedYes-NoIndicator#Y)
...... p17.5.2.1Describe the communities that will be involved in this research0..1text
...... p17.5.2.2Describe the composition and involvement of any community advisory board0..1text
...... p17.5.2.3Describe the involvement of the community in the design, protocol development, informed consent process, access to data and samples, and conduct of the research0..1text
...... p17.5.2.4Describe the plans on dissemination and publication of study results which are in agreement with the community0..1text
.... p17.6Multi Site Research0..1group
..... p17.6.1Describe the plan for tracking IRB approval of documents and consent forms for each site0..1text
..... p17.6.2Name of the sponsor(s) and Contract Research Organization (CRO)0..1group
...... ExternalDataFor_p17.6.2.1External Data For linkId p17.6.2.10..*open-choiceiconExpressions:
  • Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value
...... p17.6.2.1Name of the sponsor(s)0..*open-choice
...... p17.6.2.2Name of the Contract Research Organization (CRO)0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'CRO').item.where(linkId = 'in5.2').answer.value
..... p17.6.3Describe 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 documented0..1text
..... p17.6.4Describe the plan for ensuring that amendments to the Coordinating Center template protocol and template consent forms will be communicated to all sites0..1text
..... p17.6.5Describe the plan for ensuring that all sites have the most current version of the protocol and consent forms0..1text
..... p17.6.6Describe 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 Policy0..1text
..... p17.6.7Plan to manage and/or monitor each site's study conduct including enrollment, research events, withdrawals and protocol deviations0..1group
...... p17.6.7.1Describe 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..1text
...... p17.6.7.2Describe whether monitoring visits will be conducted. If so, how often? What will the site monitoring visits entail?0..1text
..... p17.6.8Describe 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..1text
..... p17.6.9Plan for handling of the investigational product (drug/device/biologic) at each site (if applicable)0..1group
...... p17.6.9.1Describe how they will be provided to each enrolling site0..1text
...... p17.6.9.2Describe how dispensing will be monitored0..1text
...... p17.6.9.3Describe what investigational product accountability procedures will be implemented0..1text
..... p17.6.10Describe the procedures for study closures and early site termination0..1text
..... p17.6.11Describe 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..1text
.... p17.7Key Roles and Study Governance0..1text
... p18Study Finances0..1group
.... p18.1Funding Source0..1text
.... p18.2Costs to the participant0..1text
.... p18.3Participant Reimbursements or Payments0..1text
.... p18.4Compensation for Research-Related Injury0..1text
... p19References0..1group
.... p19.1List any references here, unless already cited.0..1text
.... p19.2Reference list attachment (optional)0..1group
..... p19.2.1Describe the file that is being attached (optional)0..1string
..... p19.2.2Attachment0..1attachment
..... p19.2_helpReference list can be attached here0..1display
... p25Other Attachments to the Protocol0..1group
.... p25.1Other Attachment(s) to the Protocol0..*group
..... p25.1.1Describe the file that is being attached0..1string
..... p25.1.2Attachment0..1attachment
..... p25.1_helpAttach any other relevant materials here, if not attached in other sections of the form0..1display
... ADMIN00Administrative Use Only0..1groupicon
.... ADMIN01Link ID prefix0..1stringiconInitial Value: string = p
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any0..1stringiconInitial Value: string = temporarily unavailable
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any0..1stringiconInitial Value: string = temporarily unavailable
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value
.... ADMIN04Questionnaire Response ID of the local considerations Questionnaire Response, if any0..1stringicon

doco Documentation for this format

Option Sets

Answer options for p1.1

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#INT ("Interventional")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OBS ("Observational")

Answer options for p1.2

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DBV ("Drug/Biologic/Vaccine")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DEV ("Device")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#SBE ("Social/Behavioral/educational (SBE)")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PRO ("Procedural")

Answer options for p1.3

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p1.30

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p1.4

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IND ("IND")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IDE ("IDE")

Answer options for p1.7

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p1.8.1

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#COPI ("Co-Principal Investigator")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#COI ("Co-Investigator")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PD ("Program Director")

Answer options for p3.1.8

  • http://terminology.hl7.org/CodeSystem/research-study-phase#phase-2 ("Phase 2")
  • http://terminology.hl7.org/CodeSystem/research-study-phase#phase-3 ("Phase 3")
  • http://terminology.hl7.org/CodeSystem/research-study-phase#phase-4 ("Phase 4")

Answer options for p4.1.4

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p4.1.7

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p4.1.8.2

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p4.1.8.3

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p4.3.1.5

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.4

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.1

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.2.2

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.2.4

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.3

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.31.5

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.31.6

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.31.7

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.31.8

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.4

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.5.1

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.5.3.8

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.6

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.8

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.9.12

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.10

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.11.4

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.12

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.13.6

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.14

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.15.6

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.15.7.4

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p17.3.5

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p17.4.1

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p17.4.2

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p17.5.1

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")