Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

Example Questionnaire: Determination Questionnaire with pre-population

Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. SIRBDeterminationQuestionnaireQuestionnaire
... dl1Research Study0..1group
.... dl1.1Study Title1..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.item.item.where(linkId = 'in1.2').answer.value
..... dl1.1_helpShort Title of the Research Study0..1display
.... dl1.2IRB Protocol Number0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.item.item.where(linkId = 'in1.3').answer.value
..... dl1.2_helpIRB number assigned by the site institution0..1display
... dl2Reliance Determination0..1group
.... dl2.1sIRB (Reviewing Institution)0..1group
..... dl2.1_helpIRB responsible for the overall approval of the study, and whose approval will then stand for the relying institutions in the network.0..1display
..... dl2.1.1Institution0..1group
...... dl2.1.1_helpInstitution providing overall review of study for most sites enrolling participants in a researach study. Its role is to protect the rights and welfare of human research participants in research activities conducted; it has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction for all relying sites0..1display
...... dl2.1.1.1sIRB (Reviewing Institution) Name1..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.item.item.where(linkId = 'in6.1').answer.value
...... dl2.1.1.2Federal Wide Assurance (FWA):0..1integerExpressions:
  • Initial Value: %lookupInitiateStudy.item.item.where(linkId = 'in6.9').answer.value
....... dl2.1.1.2_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. Enter just the numeric value of the FWA.0..1display
..... dl2.1.2Point of Contact0..1group
...... dl2.1.2_helpMain study personnel with which a study participant will interact. This may be also be the Site PI or a study coordinator or other site personnel.0..1display
...... dl2.1.2.1First Name1..1string
....... dl2.1.2.1_helpFirst or given name associated with the point of contact0..1display
...... dl2.1.2.2Last Name1..1string
....... dl2.1.2.2_helpSurname or family name associated with the point of contact0..1display
...... dl2.1.2.4Suffix0..1string
....... d2.1.2.4_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the point of contact0..1display
...... dl2.1.2.5Professional Degree(s)0..1string
....... dl2.1.2.5_helpProfessional and Academic degrees associated with the point of contact0..1display
...... dl2.1.2.3Email1..1string
..... dl2.1.3Overall Principal Investigator0..1group
...... dl2.1.3_helpPrincipal Investigator responsible for the conduct of the study overall; oversees all participating sites0..1display
...... dl2.1.3.1First Name1..1stringExpressions:
  • Initial Value: QuestionnaireResponse.item.item.where(linkId = 'in7.1').answer.value
....... dl2.1.3.1_helpFirst or Given name associated with the overall principal investigator0..1display
...... dl2.1.3.2Last Name1..1stringExpressions:
  • Initial Value: QuestionnaireResponse.item.item.where(linkId = 'in7.2').answer.value
....... dl2.1.3.2_helpSurname or family name associated with the overall principal investigator0..1display
...... dl2.1.3.4Suffix0..1stringExpressions:
  • Initial Value: QuestionnaireResponse.item.item.where(linkId = 'in7.3').answer.value
....... dl2.1.3.4_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the overall principal investigator's name0..1display
...... dl2.1.3.5Degree(s)0..1stringExpressions:
  • Initial Value: QuestionnaireResponse.item.item.where(linkId = 'in7.4').answer.value
....... dl2.1.3.5_helpProfessional and Academic degrees associated with the overall principal investigator0..1display
...... dl2.1.3.3Email1..1stringExpressions:
  • Initial Value: QuestionnaireResponse.item.item.where(linkId = 'in7.13').answer.value
.... dl2.2Determination Decision1..1choiceOptions: 2 options
.... dl2.3Relying IRB0..1group
..... dl2.3_helpIRB relying on the decisions of the reviewing IRB0..1display
..... dl2.3.1Institution0..1group
...... dl2.3.1_helpName of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.0..1display
...... dl2.3.1.1Name1..1choice
...... dl2.3.1.2Federal Wide Assurance (FWA)0..1integerExpressions:
  • Initial Value: %lookupInitiateStudy.item.where(item.item.where(linkId = 'in8.1.1' and answer.value = %valueSelected-RelyingSite)).item.where(linkId = 'in8.1').item.where(linkId = 'in8.1.5').answer.value
....... dl2.3.1.2_helpDHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA.0..1display
..... dl2.3.2Site Principal Investigator0..1group
...... dl2.3.2_helpInvestigator responsible for the conduct of the study at a specific research location.0..1display
...... dl2.3.2.1First Name1..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.item.where(item.item.where(linkId = 'in8.1.1' and answer.value = %valueSelected-RelyingSite )).item.where(linkId = 'in8.3').item.where(linkId = 'in8.3.1').answer.value
....... dl2.3.2.1_helpFirst or Given name associated with the site investigator0..1display
...... dl2.3.2.2Last Name1..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.item.where(item.item.where(linkId = 'in8.1.1' and answer.value = %valueSelected-RelyingSite )).item.where(linkId = 'in8.3').item.where(linkId = 'in8.3.2').answer.value
....... dl2.3.2.2_helpSurname or family name associated with the site investigator0..1display
...... dl2.3.2.4Suffix0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.item.where(item.item.where(linkId = 'in8.1.1' and answer.value = %valueSelected-RelyingSite )).item.where(linkId = 'in8.3').item.where(linkId = 'in8.3.3').answer.value
....... dl2.3.2.4_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the site principal investigator's name0..1display
...... dl2.3.2.5Professional Degree(s)0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.item.where(item.item.where(linkId = 'in8.1.1' and answer.value = %valueSelected-RelyingSite )).item.where(linkId = 'in8.3').item.where(linkId = 'in8.3.4').answer.value
....... dl2.3.2.5_helpProfessional and Academic degrees associated with the site investigator0..1display
...... dl2.3.2.3Email1..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.item.where(item.item.where(linkId = 'in8.1.1' and answer.value = %valueSelected-RelyingSite )).item.where(linkId = 'in8.3').item.where(linkId = 'in8.3.4').answer.value
... ADMIN00Administrative Use Only0..1group
.... ADMIN01Link ID prefix0..1stringInitial Value: string = dl
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.item.item.where(linkId = 'ADMIN02').answer.value
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any0..1stringInitial Value: string = temporarily unavailable
Expressions:
  • Initial Value: %lookupInitiateStudy.item.item.where(linkId = 'ADMIN03').answer.value
.... ADMIN04Questionnaire Response ID of the local considerations Questionnaire Response, if any0..1string

doco Documentation for this format

Option Sets

Answer options for dl2.2