Questionnaire-sirb-determination-letter-questionnaire-populate

Sourcehl7.fhir.us.sirb#current:Single Institutional Review Board (sIRB) Implementation Guide (v4.0.1)
resourceTypeQuestionnaire
idsirb-determination-letter-questionnaire-populate
canonicalhttp://hl7.org/fhir/us/sirb/Questionnaire/sirb-determination-letter-questionnaire-populate
version1.0.0
statusdraft
publisherHL7 International - BR&R Work Group
nameSIRBDeterminationQuestionnaire
titlesIRB Determination Questionnaire
date2023-03-29T06:17:19+00:00
experimentalfalse
jurisdictionsus
Usages(none)

Research Study

  • linkId: dl1

Study Title *

  • linkId: dl1.1

Short Title of the Research Study

  • linkId: dl1.1_help

IRB Protocol Number

  • linkId: dl1.2

IRB number assigned by the site institution

  • linkId: dl1.2_help

Reliance Determination

  • linkId: dl2

sIRB (Reviewing Institution)

  • linkId: dl2.1

Institution

  • linkId: dl2.1.1

sIRB (Reviewing Institution) Name *

  • linkId: dl2.1.1.1

Federal Wide Assurance (FWA)

  • linkId: dl2.1.1.2

DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA.

  • linkId: dl2.1.1.2_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.

  • linkId: dl2.1.1_help

IRB responsible for the overall approval of the study, and whose approval will then stand for the relying institutions in the network.

  • linkId: dl2.1_help

Determination Decision *

Lead Principal Investigator Responsible for Overall Study

  • linkId: dl5

First Name *

  • linkId: dl5.1

First or Given name of the lead principal investigator

  • linkId: dl5.1_help

Last Name *

  • linkId: dl5.2

Surname or family name

  • linkId: dl5.2_help

Suffix

  • linkId: dl5.4

Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.

  • linkId: dl5.4_help

Degree(s)

  • linkId: dl5.5

Professional and Academic degrees of the lead principal investigator

  • linkId: dl5.5_help

Email *

  • linkId: dl5.3

Prinicpal investigator leading the study, ultimately responsible for the overall conduct of the study

  • linkId: dl5_help

Lead Principal Investigator Institution

  • linkId: dl11

Lead Principal Investigator Institution Name *

  • linkId: dl11.1

Relying IRB

  • linkId: dl7

Relying institution and Relying Site Principal Investigator for this Determination Letter

  • linkId: dl7.5

External Data For linkId dl7.5.1

  • Flags: icon
  • linkId: ExternalDataFor_dl7.5.1

Select the relying site in order to pre-populate the relying institution and relying site principal investigator details below.

  • linkId: dl7.5.1

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.

  • linkId: dl7.5.1_help

Relying Institution

  • linkId: dl7.1

Name *

  • linkId: dl7.1.1

Federal Wide Assurance (FWA)

  • linkId: dl7.1.2

DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA.

  • linkId: dl7.1.2_help

Name of Institution where its IRB has agreed to IRB oversite by the reviewing IRB (sIRB)

  • linkId: dl7.1_help

Relying Site Principal Investigator

  • linkId: dl7.2

First Name *

  • linkId: dl7.2.1

First or Given name of the site investigator

  • linkId: dl7.2.1_help

Last Name *

  • linkId: dl7.2.2

Surname or family name

  • linkId: dl7.2.2_help

Suffix

  • linkId: dl7.2.4

Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.

  • linkId: dl7.2.4_help

Professional Degree(s)

  • linkId: dl7.2.5

Professional and Academic degrees of the site investigator

  • linkId: dl7.2.5_help

Email *

  • linkId: dl7.2.3

Site principal investigator responsible for the conduct of the study at the relying site research location for which this Determination Letter is being created

  • linkId: dl7.2_help

IRB at relying institution that has agreed to IRB oversite by the reviewing IRB (sIRB)

  • linkId: dl7_help

Point of Contact for Study Participants

  • linkId: dl9

Primary person with whom a study participant will interact: may be PI or study coordinator or other designated personnel.

  • linkId: dl9_help

First Name *

  • linkId: dl9.1

First or given name of the point of contact

  • linkId: dl9.1_help

Last Name *

  • linkId: dl9.2

Surname or family name

  • linkId: dl9.2_help

Suffix

  • linkId: dl9.4

Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.

  • linkId: dl9.4_help

Professional Degree(s)

  • linkId: dl9.5

Professional and Academic degrees of the point of contact

  • linkId: dl9.5_help

Email *

  • linkId: dl9.3

Administrative Use Only

  • Flags: icon
  • linkId: ADMIN00

Link ID prefix

  • Flags: icon
  • linkId: ADMIN01
  • Initial Values: dl

Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any

  • Flags: icon
  • linkId: ADMIN02
  • Initial Values: temporarily unavailable

ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any

  • Flags: icon
  • linkId: ADMIN03
  • Initial Values: temporarily unavailable

Questionnaire Response ID of the local considerations Questionnaire Response, if any

  • Flags: icon
  • linkId: ADMIN04

Produced 06 Apr 2023