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: Initiate a Study Questionnaire

Official URL: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate Version: 1.0.0
Draft as of 2023-04-20 Computable Name: SIRBInitiateAStudyQuestionnaire

Initiate a Study Questionnaire

Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. SIRBInitiateAStudyQuestionnaireInitiate a Study QuestionnaireQuestionnairehttp://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate#1.0.0
... in1Research Study Details0..1group
.... in1.1Study Title1..1string
..... in1.1_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
.... in1.2Study Title (Short)1..1string
..... in1.2_helpA short study title written in language intended for the lay public.0..1display
.... in1.3IRB Protocol Number1..1string
..... in1.3_helpThe Protocol Number assigned by the sIRB0..1display
.... in1.4Study Type1..1choiceOptions: 2 options
..... in1.4_helpSelect the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)0..1display
... DIVIDER1null0..1display
... in5Other Organization(s) Involved0..*group
.... in5.1Relationship Type1..1choiceOptions: 2 options
..... in5.1_helpSelect the organization's type of involvement in the study0..1display
.... in5.2Organization Name1..1string
..... in5.2_helpe.g. NIH or company name0..1display
.... in5.3Phone0..1string
..... in5.3_help10 digit phone number, including area code0..1display
.... in5.4Sponsor or Funding Source Protocol Number, if applicable0..1string
..... in5.4_helpUnique Protocol Identification Number used by the sponsor, if applicable0..1display
.... in5.5Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)0..1stringiconiconExpressions:
.... in5.6Protocol Number with Organization Name (read-only)0..1stringiconiconExpressions:
... DIVIDER2null0..1display
... in6sIRB (Reviewing Institution)0..1group
.... in6.1sIRB (Reviewing Institution) Name1..1string
..... in6.1_helpName of the sIRB (Reviewing Institution)0..1display
.... in6.10Department Name or Division0..1string
..... in6.10_helpThe department name or division of the sIRB, if applicable0..1display
.... in6.3Institution Street Address1..1string
..... in6.3_helpPhysical address of the sIRB (Reviewing Institution)0..1display
.... in6.4Institution City1..1string
.... in6.5Institution State1..1string
.... in6.6Institution Zip Code1..1string
.... in6.7Institution Country0..1stringInitial Value: string = United States
.... in6.8Is a Federal Wide Assurance (FWA) Number assigned?1..1choiceOptions: 4 options
..... in6.8_helpDHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".0..1display
.... in6.9Federal Wide Assurance Number (if assigned)0..1integerEnable When: in6.8 = Yes (expandedYes-NoIndicator#Y)
..... in6.9_helpIf assigned, enter just numeric value of FWA.0..1display
.... in6.11Is the sIRB a 3rd party institution?0..1choiceOptions: 2 options
..... in6.11_helpIs the sIRB an external 3rd party institution, outside of the lead Principal Investigator institution?0..1display
... DIVIDER3null0..1display
... in7Lead Principal Investigator0..1group
.... in7.1Lead Principal Investigator Institution0..1group
..... in7.1.1Lead Principal Investigator Institution Name1..1string
...... in7.1.1_helpName of institution for the lead principal investigator0..1display
..... in7.1.10Department Name or Division0..1string
...... in7.1.10_helpThe department name or division of the lead principal investigator0..1display
..... in7.1.3Institution Phone0..1string
...... in7.1.3_help10-digit phone number, including area code, for the institution of the lead principal investigator0..1display
..... in7.1.4Is a Federal Wide Assurance (FWA) Number assigned?1..1choiceOptions: 4 options
...... in7.1.4_helpDHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".0..1display
..... in7.1.5Federal Wide Assurance Number (if assigned)0..1integerEnable When: in7.1.4 = Yes (expandedYes-NoIndicator#Y)
...... in7.1.5_helpIf assigned, enter just numeric value of FWA.0..1display
.... in7.3Lead Principal Investigator0..1group
..... in7.3.1Lead Principal Investigator First Name1..1string
...... in7.3.1_helpFirst Name or Given Name of the lead PI responsible for the overall study0..1display
..... in7.3.2Lead Principal Investigator Last Name1..1string
...... in7.3.2_helpLast name, surname or family name of the lead PI responsible for the overall study0..1display
..... in7.3.3Lead Principal Investigator Suffix0..1string
...... in7.3.3_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
..... in7.3.4Academic and Professional Degrees associated with the Lead Principal Investigator1..1string
...... in7.3.4_helpAcademic and Professional degrees associated with the lead principal investigator0..1display
..... in7.3.10Department Name or Division0..1string
...... in7.3.10_helpThe department name or division of the lead PI0..1display
..... in7.3.5Phone0..1string
...... in7.3.5_help10-digit phone number, including area code, for the lead principal investigator0..1display
..... in7.3.6Email address0..1string
...... in7.3.6_helpEmail address associated with the lead principal investigator0..1display
..... in7.3.7Address of Lead Principal Investigator0..1group
...... in7.3.7.1Street Address0..1string
....... in7.3.7.1_helpPhysical address0..1display
...... in7.3.7.2City1..1string
...... in7.3.7.3State1..1string
...... in7.3.7.4Zip Code0..1string
...... in7.3.7.5Country0..1stringInitial Value: string = United States
.... in7.9Lead Principal Investigator Unique Site (read-only)0..1stringiconiconExpressions:
.... in7.10Lead Principal Investigator Full Name, Suffix and Degrees0..1stringiconiconExpressions:
... DIVIDER4null0..1display
... in8Relying Site(s)0..*group
.... in8.5Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator0..1group
..... in8.5.1Is this relying site at the same institution as where the lead principal investigator is conducting the study?0..1choiceOptions: 2 options
...... in8.5.1_helpThis question is optional. It can be used to pre-populate the lead principal investigator institution details if this relying site is at the same institution as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.0..1display
..... in8.5.2Is this relying site at the same site as where the lead principal investigator is conducting the study?0..1choiceEnable When: in8.5.1 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
...... in8.5.2_helpThis question is optional. It can be used to pre-populate the lead principal investigator site details if this relying site is at the same site as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.0..1display
..... in8.5.3Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?0..1choiceOptions: 2 options
...... in8.5.3_helpThis question is optional. It can be used to pre-populate the lead principal investigator details if this relying site PI is the same PI as the lead principal investigator conducting the study. If you do not want pre-population to occur, you may leave this question blank.0..1display
..... in8.5.4Is this relying site also considered to be the lead site for the study?1..1choiceOptions: 2 options
...... in8.5.4_helpIndicator that the lead PI site where the study is being conducted is also participating as this relying site0..1display
.... in8.1Relying Site Institution0..1group
..... in8.1.1Relying Institution Name1..1stringExpressions:
  • Calculated Value: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.1').answer.value)
...... in8.1.1_helpName of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.0..1display
..... in8.1.10Department Name or Division0..1stringExpressions:
  • Calculated Value: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.10').answer.value)
...... in8.1.10_helpThe department name or division for the relying site0..1display
..... in8.1.3Relying Institution Phone0..1stringExpressions:
  • Calculated Value: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.3').answer.value)
...... in8.1.3_help10-digit phone number, including area code, for the relying institution0..1display
..... in8.1.4Is a Federal Wide Assurance (FWA) Number assigned?1..1choiceOptions: 4 options
Expressions:
  • Calculated Value: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.4').answer.valueCoding)
...... in8.1.4_helpDHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".0..1display
..... in8.1.5Federal Wide Assurance Number (if assigned)0..1integerEnable When: in8.1.4 = Yes (expandedYes-NoIndicator#Y)
Expressions:
  • Calculated Value: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.5').answer.value)
...... in8.1.5_helpIf assigned, enter just numeric value of FWA.0..1display
..... in8.1.6Reliance Status1..1choiceOptions: 5 options
...... in8.1.6_helpStatus of the reliance agreement0..1display
..... in8.1_helpInstitution whose IRB agrees to rely on oversite by the sIRB (Reviewing IRB)0..1display
.... in8.3Relying Site Principal Investigator0..1group
..... in8.3.1Relying Site Principal Investigator First Name1..1stringExpressions:
  • Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.1').answer.value)
...... in8.3.1_helpFirst Name or Given Name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution0..1display
..... in8.3.2Relying Site Principal Investigator Last Name1..1stringExpressions:
  • Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.2').answer.value)
...... in8.3.2_helpLast name, surname or family name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution0..1display
..... in8.3.3Relying Site Principal Investigator Suffix0..1stringExpressions:
  • Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.3').answer.value)
...... in8.3.3_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
..... in8.3.4Academic and Professional Degrees associated with the Relying Site Principal Investigator0..1stringExpressions:
  • Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.4').answer.value)
...... in8.3.4_helpAcademic and Professional degrees associated with the relying site principal investigator0..1display
..... in8.3.10Department Name or Division0..1stringExpressions:
  • Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.10').answer.value)
...... in8.3.10_helpThe department name or division for the relying site PI0..1display
..... in8.3.5Phone0..1stringExpressions:
  • Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.5').answer.value)
...... in8.3.5_help10-digit phone number, including area code, for the relying site principal investigator0..1display
..... in8.3.6Email address0..1stringExpressions:
  • Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.6').answer.value)
...... in8.3.6_helpEmail address associated with the relying site principal investigator0..1display
..... in8.3.7Address of Relying Site Principal Investigator0..1group
...... in8.3.7.1Street Address0..1stringExpressions:
  • Calculated Value: iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.1').answer.value)
....... in8.3.7.1_helpPhysical address0..1display
...... in8.3.7.2City0..1stringExpressions:
  • Calculated Value: iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.2').answer.value)
...... in8.3.7.3State0..1stringExpressions:
  • Calculated Value: iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.3').answer.value)
...... in8.3.7.4Zip Code0..1stringExpressions:
  • Calculated Value: iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.4').answer.value)
...... in8.3.7.5Country0..1stringInitial Value: string = United States
..... in8.3_helpPrincipal Investigator responsible for the conduct of the study at a specific relying site research location.0..1display
.... in8.9Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)0..1stringiconiconExpressions:
.... in8.10Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)0..1stringiconiconExpressions:
.... in8_helpThe research site(s) where the Lead Principal Investigator is conducting research should also be entered as relying site(s) here, even if at the same institution as entered above for the Lead Principal Investigator. If the Lead Principal Investigator is only managing a coordinating center or other administrative office for the study, do not enter the site again here.0..1display
... DIVIDER5null0..1display
... in9FDA exemption and IDE/IND Number0..1group
.... in9.1Does this study require a FDA exemption?0..1choiceOptions: 2 options
..... in9.1_helpIndicator for use of FDA regulated product0..1display
.... in9.2Is an IND or IDE being used in this study?0..1choiceOptions: 2 options
..... in9.2_helpIs an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?0..1display
.... in9.4Please select IND or IDE:0..1choiceEnable When: in9.2 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
..... in9.4_helpSelect IND for Investigational New Drug or IDE for Investigational Device Exemption0..1display
.... in9.3IND/IDE Number0..1stringEnable When: in9.2 = Yes (expandedYes-NoIndicator#Y)
... DIVIDER6null0..1display
... in10Questionnaire Version Details0..1group
.... in10.1Questionnaire Version1..1stringiconInitial Value: string = 2
.... in10.2Questionnaire Version Date1..1dateiconInitial Value: date = 2021-10-18
... DIVIDER7null0..1display
... ADMIN00Administrative Use Only (will be hidden in the future)0..1groupicon
.... ADMIN01Link ID prefix0..1stringiconInitial Value: string = in
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any0..1stringiconInitial Value: string = temporarily unavailable
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses0..1stringiconInitial Value: string = temporarily unavailable
.... ADMIN04Questionnaire Response ID of the local considerations Questionnaire Response, if any0..1stringicon

doco Documentation for this format

Option Sets

Answer options for in1.4

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

Answer options for in5.1

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#SFS ("Sponsor or Funding Source")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#CRO ("Contract Research Organization (CRO)")

Answer options for in6.8

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

Answer options for in6.11

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

Answer options for in7.1.4

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

Answer options for in8.5.1

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

Answer options for in8.5.2

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

Answer options for in8.5.3

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

Answer options for in8.5.4

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

Answer options for in8.1.4

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

Answer options for in8.1.6

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#APPROVED ("Approved for reliance")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DENIED ("Denied reliance")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#POSSIBLE ("Potential/possible")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#CANCELLED ("Cancelled or not participating")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ONHOLD ("Temporarily on hold")

Answer options for in9.1

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

Answer options for in9.2

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

Answer options for in9.4

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