Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

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

LinkId | Text | Cardinality | Type | Flags | Description & Constraints
--- | --- | --- | --- | --- | ---
SIRBDeterminationQuestionnaire |  |  | Questionnaire |  | http://hl7.org/fhir/us/sirb/Questionnaire/sirb-determination-letter-questionnaire-populate#1.0.0
dl1 | Research Study | 0..1 | group |  |
dl1.1 | Study Title | 1..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value`
dl1.1_help | Short Title of the Research Study | 0..1 | display |  |
dl1.2 | IRB Protocol Number | 0..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value`
dl1.2_help | IRB number assigned by the site institution | 0..1 | display |  |
dl2 | Reliance Determination | 0..1 | group |  |
dl2.1 | sIRB (Reviewing Institution) | 0..1 | group |  |
dl2.1.1 | Institution | 0..1 | group |  |
dl2.1.1.1 | sIRB (Reviewing Institution) Name | 1..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value`
dl2.1.1.2 | Federal Wide Assurance (FWA) | 0..1 | integer |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in6.9').answer.value`
dl2.1.1.2_help | DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA. | 0..1 | display |  |
dl2.1.1_help | Institution 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..1 | display |  |
dl2.1_help | IRB responsible for the overall approval of the study, and whose approval will then stand for the relying institutions in the network. | 0..1 | display |  |
dl2.2 | Determination Decision | 1..1 | choice |  | Options: 2 options
dl5 | Lead Principal Investigator Responsible for Overall Study | 0..1 | group |  |
dl5.1 | First Name | 1..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value`
dl5.1_help | First or Given name of the lead principal investigator | 0..1 | display |  |
dl5.2 | Last Name | 1..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value`
dl5.2_help | Surname or family name | 0..1 | display |  |
dl5.4 | Suffix | 0..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value`
dl5.4_help | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. | 0..1 | display |  |
dl5.5 | Degree(s) | 0..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value`
dl5.5_help | Professional and Academic degrees of the lead principal investigator | 0..1 | display |  |
dl5.3 | Email | 1..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value`
dl5_help | Prinicpal investigator leading the study, ultimately responsible for the overall conduct of the study | 0..1 | display |  |
dl11 | Lead Principal Investigator Institution | 0..1 | group |  |
dl11.1 | Lead Principal Investigator Institution Name | 1..1 | string |  | Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value`
dl7 | Relying IRB | 0..1 | group |  |
dl7.5 | Relying institution and Relying Site Principal Investigator for this Determination Letter | 0..1 | group |  |
ExternalDataFor_dl7.5.1 | External Data For linkId dl7.5.1 | 0..* | open-choice |  | Expressions: Initial Value: `%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value`
dl7.5.1 | Select the relying site in order to pre-populate the relying institution and relying site principal investigator details below. | 0..1 | choice |  |
dl7.5.1_help | This 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..1 | display |  |
dl7.1 | Relying Institution | 0..1 | group |  |
dl7.1.1 | Name | 1..1 | string |  | Expressions: Calculated Value: `%lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value`
dl7.1.2 | Federal Wide Assurance (FWA) | 0..1 | integer |  | Expressions: 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_help | DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA. | 0..1 | display |  |
dl7.1_help | Name of Institution where its IRB has agreed to IRB oversite by the reviewing IRB (sIRB) | 0..1 | display |  |
dl7.2 | Relying Site Principal Investigator | 0..1 | group |  |
dl7.2.1 | First Name | 1..1 | string |  | Expressions: 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_help | First or Given name of the site investigator | 0..1 | display |  |
dl7.2.2 | Last Name | 1..1 | string |  | Expressions: 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_help | Surname or family name | 0..1 | display |  |
dl7.2.4 | Suffix | 0..1 | string |  | Expressions: 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_help | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. | 0..1 | display |  |
dl7.2.5 | Professional Degree(s) | 0..1 | string |  | Expressions: 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_help | Professional and Academic degrees of the site investigator | 0..1 | display |  |
dl7.2.3 | Email | 1..1 | string |  | Expressions: 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_help | Site principal investigator responsible for the conduct of the study at the relying site research location for which this Determination Letter is being created | 0..1 | display |  |
dl7_help | IRB at relying institution that has agreed to IRB oversite by the reviewing IRB (sIRB) | 0..1 | display |  |
dl9 | Point of Contact for Study Participants | 0..1 | group |  |
dl9_help | Primary person with whom a study participant will interact: may be PI or study coordinator or other designated personnel. | 0..1 | display |  |
dl9.1 | First Name | 1..1 | string |  |
dl9.1_help | First or given name of the point of contact | 0..1 | display |  |
dl9.2 | Last Name | 1..1 | string |  |
dl9.2_help | Surname or family name | 0..1 | display |  |
dl9.4 | Suffix | 0..1 | string |  |
dl9.4_help | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. | 0..1 | display |  |
dl9.5 | Professional Degree(s) | 0..1 | string |  |
dl9.5_help | Professional and Academic degrees of the point of contact | 0..1 | display |  |
dl9.3 | Email | 1..1 | string |  |
ADMIN00 | Administrative Use Only | 0..1 | group |  |
ADMIN01 | Link ID prefix | 0..1 | string |  | Initial Value: string = dl
ADMIN02 | Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any | 0..1 | string |  | Initial Value: string = temporarily unavailable Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value`
ADMIN03 | ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any | 0..1 | string |  | Initial Value: string = temporarily unavailable Expressions: Initial Value: `%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value`
ADMIN04 | Questionnaire Response ID of the local considerations Questionnaire Response, if any | 0..1 | string |  |
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")