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

Example QuestionnaireResponse: Example Determination Letter Questionnaire Response

LinkIdTextDefinitionAnswerdoco
.. determination-populate-exampleQRQuestionnaireResponse
... dl1Research Study
.... dl1.1Study TitleStudy of Drug A for arthritis
.... dl1.2IRB Protocol NumberPRO098765
... dl2Reliance Determination
.... dl2.1sIRB (Reviewing Institution)
..... dl2.1.1Institution
...... dl2.1.1.1sIRB (Reviewing Institution) NameX Pharmaceutical Research IRB
...... dl2.1.1.2Federal Wide Assurance (FWA)12345
.... dl2.2Determination DecisionTemporary Codes AR: Accepts Review
... dl5Lead Principal Investigator Responsible for Overall Study
.... dl5.1First NameJane
.... dl5.2Last NameDoe
.... dl5.5Degree(s)MD
.... dl5.3Emaildrjanedoe@sampleuniversity.edu
... dl11Lead Principal Investigator Institution
.... dl11.1Lead Principal Investigator Institution NameSample University Medical Center
... dl7Relying IRB
.... dl7.5Relying institution and Relying Site Principal Investigator for this Determination Letter
..... ExternalDataFor_dl7.5.1External Data For linkId dl7.5.1
..... dl7.5.1Select the relying site in order to pre-populate the relying institution and relying site principal investigator details below.[not stated] : Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
.... dl7.1Relying Institution
..... dl7.1.1NameTest Example University
..... dl7.1.2Federal Wide Assurance (FWA)34567
.... dl7.2Relying Site Principal Investigator
..... dl7.2.1First NameXi-Yang
..... dl7.2.2Last NameLee
..... dl7.2.4SuffixJr.
..... dl7.2.5Professional Degree(s)MD, PhD
..... dl7.2.3EmailXiYangLee@teu.med.edu
... dl9Point of Contact for Study Participants
.... dl9.1First NameXi-Yang
.... dl9.2Last NameLee
.... dl9.4SuffixJr.
.... dl9.5Professional Degree(s)MD, PhD
.... dl9.3EmailXiYangLee@teu.med.edu
... ADMIN00Administrative Use Only
.... ADMIN01Link ID prefixdl
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if anyinitiate-study-populate-exampleQR
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if anyResearchStudyExample-sIRB

doco Documentation for this format