Single Institutional Review Board (sIRB) Implementation Guide
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Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. See the Directory of published versions

Questionnaire: Determination Letter Questionnaire

Official URL: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-determination-letter-questionnaire-populate Version: 1.0.0
Draft as of 2023-04-24 Computable Name: SIRBDeterminationQuestionnaire
Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. SIRBDeterminationQuestionnaireQuestionnairehttp://hl7.org/fhir/us/sirb/Questionnaire/sirb-determination-letter-questionnaire-populate#1.0.0
... dl1Research Study0..1group
.... dl1.1Study Title1..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value
..... dl1.1_helpShort Title of the Research Study0..1display
.... dl1.2IRB Protocol Number0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().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
..... dl2.1.1Institution0..1group
...... dl2.1.1.1sIRB (Reviewing Institution) Name1..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value
...... dl2.1.1.2Federal Wide Assurance (FWA)0..1integerExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.9').answer.value
....... dl2.1.1.2_helpDHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA.0..1display
...... dl2.1.1_helpInstitution providing overall review of research study activities for most sites enrolling participants in a researach study. Its role is to protect the rights and welfare of human research participants. It has the authority to approve and require modifications of all research activities that fall within its jurisdiction for all relying sites.0..1display
..... 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
.... dl2.2Determination Decision1..1choiceOptions: 2 options
... dl5Lead Principal Investigator Responsible for Overall Study0..1group
.... dl5.1First Name1..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value
..... dl5.1_helpFirst or Given name of the lead principal investigator0..1display
.... dl5.2Last Name1..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value
..... dl5.2_helpSurname or family name0..1display
.... dl5.4Suffix0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value
..... dl5.4_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
.... dl5.5Degree(s)0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value
..... dl5.5_helpProfessional and Academic degrees of the lead principal investigator0..1display
.... dl5.3Email1..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value
.... dl5_helpPrinicpal investigator leading the study, ultimately responsible for the overall conduct of the study0..1display
... dl11Lead Principal Investigator Institution0..1group
.... dl11.1Lead Principal Investigator Institution Name1..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value
... dl7Relying IRB0..1group
.... dl7.5Relying institution and Relying Site Principal Investigator for this Determination Letter0..1group
..... ExternalDataFor_dl7.5.1External Data For linkId dl7.5.10..*open-choiceiconExpressions:
  • Initial Value: %lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value
..... dl7.5.1Select the relying site in order to pre-populate the relying institution and relying site principal investigator details below.0..1choice
...... dl7.5.1_helpThis question and its answer will not print on the Determination Letter but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details.0..1display
.... dl7.1Relying Institution0..1group
..... dl7.1.1Name1..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value
..... dl7.1.2Federal Wide Assurance (FWA)0..1integerExpressions:
  • Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.5').answer.value
...... dl7.1.2_helpDHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA.0..1display
..... dl7.1_helpName of Institution where its IRB has agreed to IRB oversite by the reviewing IRB (sIRB)0..1display
.... dl7.2Relying Site Principal Investigator0..1group
..... dl7.2.1First Name1..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value
...... dl7.2.1_helpFirst or Given name of the site investigator0..1display
..... dl7.2.2Last Name1..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value
...... dl7.2.2_helpSurname or family name0..1display
..... dl7.2.4Suffix0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value
...... dl7.2.4_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
..... dl7.2.5Professional Degree(s)0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value
...... dl7.2.5_helpProfessional and Academic degrees of the site investigator0..1display
..... dl7.2.3Email1..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value
..... dl7.2_helpSite principal investigator responsible for the conduct of the study at the relying site research location for which this Determination Letter is being created0..1display
.... dl7_helpIRB at relying institution that has agreed to IRB oversite by the reviewing IRB (sIRB)0..1display
... dl9Point of Contact for Study Participants0..1group
.... dl9_helpPrimary person with whom a study participant will interact: may be PI or study coordinator or other designated personnel.0..1display
.... dl9.1First Name1..1string
..... dl9.1_helpFirst or given name of the point of contact0..1display
.... dl9.2Last Name1..1string
..... dl9.2_helpSurname or family name0..1display
.... dl9.4Suffix0..1string
..... dl9.4_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
.... dl9.5Professional Degree(s)0..1string
..... dl9.5_helpProfessional and Academic degrees of the point of contact0..1display
.... dl9.3Email1..1string
... ADMIN00Administrative Use Only0..1groupicon
.... ADMIN01Link ID prefix0..1stringiconInitial Value: string = dl
.... 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 dl2.2

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#AR ("Accepts Review")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DR ("Denies Review")