Questionnaire-sirb-initiate-study-questionnaire-populate

Sourcehl7.fhir.us.sirb#current:Single Institutional Review Board (sIRB) Implementation Guide (v4.0.1)
resourceTypeQuestionnaire
idsirb-initiate-study-questionnaire-populate
canonicalhttp://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate
version1.0.0
statusdraft
publisherHL7 International - BR&R Work Group
nameSIRBInitiateAStudyQuestionnaire
titleInitiate a Study Questionnaire
date2023-03-29T06:17:19+00:00
descriptionInitiate a Study Questionnaire
jurisdictionsus
Usages(none)

Research Study Details

  • linkId: in1

Study Title *

  • linkId: in1.1

The official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s)

  • linkId: in1.1_help

Study Title (Short) *

  • linkId: in1.2

A short study title written in language intended for the lay public.

  • linkId: in1.2_help

IRB Protocol Number *

  • linkId: in1.3

The Protocol Number assigned by the sIRB

  • linkId: in1.3_help

Study Type *

Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)

  • linkId: in1.4_help

  • linkId: DIVIDER1

Other Organization(s) Involved

  • linkId: in5

Relationship Type *

Select the organization's type of involvement in the study

  • linkId: in5.1_help

Organization Name *

  • linkId: in5.2

e.g. NIH or company name

  • linkId: in5.2_help

Phone

  • linkId: in5.3

10 digit phone number, including area code

  • linkId: in5.3_help

Sponsor or Funding Source Protocol Number, if applicable

  • linkId: in5.4

Unique Protocol Identification Number used by the sponsor, if applicable

  • linkId: in5.4_help

Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)

  • Flags: icon
  • linkId: in5.5

Protocol Number with Organization Name (read-only)

  • Flags: icon
  • linkId: in5.6

  • linkId: DIVIDER2

sIRB (Reviewing Institution)

  • linkId: in6

sIRB (Reviewing Institution) Name *

  • linkId: in6.1

Name of the sIRB (Reviewing Institution)

  • linkId: in6.1_help

Department Name or Division

  • linkId: in6.10

The department name or division of the sIRB, if applicable

  • linkId: in6.10_help

Institution Street Address *

  • linkId: in6.3

Physical address of the sIRB (Reviewing Institution)

  • linkId: in6.3_help

Institution City *

  • linkId: in6.4

Institution State *

  • linkId: in6.5

Institution Zip Code *

  • linkId: in6.6

Institution Country

  • linkId: in6.7
  • Initial Values: United States

Is a Federal Wide Assurance (FWA) Number assigned? *

DHHS 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. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".

  • linkId: in6.8_help

Federal Wide Assurance Number (if assigned)

  • linkId: in6.9
  • Enable When: todo

If assigned, enter just numeric value of FWA.

  • linkId: in6.9_help

Is the sIRB a 3rd party institution?

Is the sIRB an external 3rd party institution, outside of the lead Principal Investigator institution?

  • linkId: in6.11_help

  • linkId: DIVIDER3

Lead Principal Investigator

  • linkId: in7

Lead Principal Investigator Institution

  • linkId: in7.1

Lead Principal Investigator Institution Name *

  • linkId: in7.1.1

Name of institution for the lead principal investigator

  • linkId: in7.1.1_help

Department Name or Division

  • linkId: in7.1.10

The department name or division of the lead principal investigator

  • linkId: in7.1.10_help

Institution Phone

  • linkId: in7.1.3

10-digit phone number, including area code, for the institution of the lead principal investigator

  • linkId: in7.1.3_help

Is a Federal Wide Assurance (FWA) Number assigned? *

DHHS 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. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".

  • linkId: in7.1.4_help

Federal Wide Assurance Number (if assigned)

  • linkId: in7.1.5
  • Enable When: todo

If assigned, enter just numeric value of FWA.

  • linkId: in7.1.5_help

Lead Principal Investigator

  • linkId: in7.3

Lead Principal Investigator First Name *

  • linkId: in7.3.1

First Name or Given Name of the lead PI responsible for the overall study

  • linkId: in7.3.1_help

Lead Principal Investigator Last Name *

  • linkId: in7.3.2

Last name, surname or family name of the lead PI responsible for the overall study

  • linkId: in7.3.2_help

Lead Principal Investigator Suffix

  • linkId: in7.3.3

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

  • linkId: in7.3.3_help

Academic and Professional Degrees associated with the Lead Principal Investigator *

  • linkId: in7.3.4

Academic and Professional degrees associated with the lead principal investigator

  • linkId: in7.3.4_help

Department Name or Division

  • linkId: in7.3.10

The department name or division of the lead PI

  • linkId: in7.3.10_help

Phone

  • linkId: in7.3.5

10-digit phone number, including area code, for the lead principal investigator

  • linkId: in7.3.5_help

Email address

  • linkId: in7.3.6

Email address associated with the lead principal investigator

  • linkId: in7.3.6_help

Address of Lead Principal Investigator

  • linkId: in7.3.7

Street Address

  • linkId: in7.3.7.1

Physical address

  • linkId: in7.3.7.1_help

City *

  • linkId: in7.3.7.2

State *

  • linkId: in7.3.7.3

Zip Code

  • linkId: in7.3.7.4

Country

  • linkId: in7.3.7.5
  • Initial Values: United States

Lead Principal Investigator Unique Site (read-only)

  • Flags: icon
  • linkId: in7.9

Lead Principal Investigator Full Name, Suffix and Degrees

  • Flags: icon
  • linkId: in7.10

  • linkId: DIVIDER4

Relying Site(s)

  • linkId: in8

Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator

  • linkId: in8.5

Is this relying site at the same institution as where the lead principal investigator is conducting the study?

This question is optional. It can be used to pre-populate the lead principal investigator institution details if this relying site is at the same institution as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.

  • linkId: in8.5.1_help

Is this relying site at the same site as where the lead principal investigator is conducting the study?

This question is optional. It can be used to pre-populate the lead principal investigator site details if this relying site is at the same site as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.

  • linkId: in8.5.2_help

Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?

This question is optional. It can be used to pre-populate the lead principal investigator details if this relying site PI is the same PI as the lead principal investigator conducting the study. If you do not want pre-population to occur, you may leave this question blank.

  • linkId: in8.5.3_help

Is this relying site also considered to be the lead site for the study? *

Indicator that the lead PI site where the study is being conducted is also participating as this relying site

  • linkId: in8.5.4_help

Relying Site Institution

  • linkId: in8.1

Relying Institution Name *

  • linkId: in8.1.1

Name of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.

  • linkId: in8.1.1_help

Department Name or Division

  • linkId: in8.1.10

The department name or division for the relying site

  • linkId: in8.1.10_help

Relying Institution Phone

  • linkId: in8.1.3

10-digit phone number, including area code, for the relying institution

  • linkId: in8.1.3_help

Is a Federal Wide Assurance (FWA) Number assigned? *

DHHS 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. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".

  • linkId: in8.1.4_help

Federal Wide Assurance Number (if assigned)

  • linkId: in8.1.5
  • Enable When: todo

If assigned, enter just numeric value of FWA.

  • linkId: in8.1.5_help

Reliance Status *

Status of the reliance agreement

  • linkId: in8.1.6_help

Institution whose IRB agrees to rely on oversite by the sIRB (Reviewing IRB)

  • linkId: in8.1_help

Relying Site Principal Investigator

  • linkId: in8.3

Relying Site Principal Investigator First Name *

  • linkId: in8.3.1

First Name or Given Name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution

  • linkId: in8.3.1_help

Relying Site Principal Investigator Last Name *

  • linkId: in8.3.2

Last name, surname or family name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution

  • linkId: in8.3.2_help

Relying Site Principal Investigator Suffix

  • linkId: in8.3.3

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

  • linkId: in8.3.3_help

Academic and Professional Degrees associated with the Relying Site Principal Investigator

  • linkId: in8.3.4

Academic and Professional degrees associated with the relying site principal investigator

  • linkId: in8.3.4_help

Department Name or Division

  • linkId: in8.3.10

The department name or division for the relying site PI

  • linkId: in8.3.10_help

Phone

  • linkId: in8.3.5

10-digit phone number, including area code, for the relying site principal investigator

  • linkId: in8.3.5_help

Email address

  • linkId: in8.3.6

Email address associated with the relying site principal investigator

  • linkId: in8.3.6_help

Address of Relying Site Principal Investigator

  • linkId: in8.3.7

Street Address

  • linkId: in8.3.7.1

Physical address

  • linkId: in8.3.7.1_help

City

  • linkId: in8.3.7.2

State

  • linkId: in8.3.7.3

Zip Code

  • linkId: in8.3.7.4

Country

  • linkId: in8.3.7.5
  • Initial Values: United States

Principal Investigator responsible for the conduct of the study at a specific relying site research location.

  • linkId: in8.3_help

Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)

  • Flags: icon
  • linkId: in8.9

Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)

  • Flags: icon
  • linkId: in8.10

The research site(s) where the Lead Principal Investigator is conducting research should also be entered as relying site(s) here, even if at the same institution as entered above for the Lead Principal Investigator. If the Lead Principal Investigator is only managing a coordinating center or other administrative office for the study, do not enter the site again here.

  • linkId: in8_help

  • linkId: DIVIDER5

FDA exemption and IDE/IND Number

  • linkId: in9

Does this study require a FDA exemption?

Indicator for use of FDA regulated product

  • linkId: in9.1_help

Is an IND or IDE being used in this study?

Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?

  • linkId: in9.2_help

Please select IND or IDE:

Select IND for Investigational New Drug or IDE for Investigational Device Exemption

  • linkId: in9.4_help

IND/IDE Number

  • linkId: in9.3
  • Enable When: todo

  • linkId: DIVIDER6

Questionnaire Version Details

  • linkId: in10

Questionnaire Version *

  • linkId: in10.1
  • Initial Values: 2

Questionnaire Version Date *

  • linkId: in10.2
  • Initial Values: 2021-10-18

  • linkId: DIVIDER7

Administrative Use Only (will be hidden in the future)

  • Flags: icon
  • linkId: ADMIN00

Link ID prefix

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

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

  • 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