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1a. Project Name

sIRB Project

1b. Project ID

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?

No

1e. Today's Date

1f. Name of standard being reaffirmed

N/A

1g. Project Artifact Information

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2b. Co-Sponsor WG

Clinical Interoperability Council

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2b. Co-Sponsor WG 2

FHIR Infrastructure

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

Monthly, at WGMs, ETC

2d. Project Facilitator

Anita Walden and Ed Hammond

2e. Other Interested Parties (and roles)

National Institute of Health-NCATS Will provide guidance on project direction and scope

Federal Drug Administration (FDA): conduct audit of the sites to evaluate the methodology of using FHIR to collect data for clinical research.

Vanderbilt will participate on pilot demonstration project

2f. Modeling Facilitator

Michael Rutherford

2g. Publishing Facilitator

James Topping

2h. Vocabulary Facilitator

Julie James

2i. Domain Expert Representative

Meredith Zozus

2j. Business Requirements Analyst

Anita Walden

2k. Conformance Facilitator

Michael rutherford

2l. Other Facilitators

Ed Hammond (Jean Duteau)- FHIR Facilitator

2m. Implementers

Duke University
University of Arkansas for Medical Sciences
Vanderbilty University

3a. Project Scope

We will develop, test and evaluate data standards to move data and documents from clinical research sites to a single ethics review board in support of the "NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.” The scope of this project will consist of two phases.

Phase I – While some standards exist and will be leveraged, significant gaps remain. We will perform an analysis identifying and addressing standards gaps to support comprehensive data and document exchange between sites and sIRBs and providing for re-use of data and documents within clinical studies. Stakeholders from the public and private sectors will vet the analysis through the IRB vendors administrators using the balloting process.

Phase II - Develop standards, prototype and demonstrate automated single internal review board (sIRB) data and document exchange. Where needed the following standards will be developed. Existing FHIR resources will be utilized when appropriate, FHIR documents to support the following data collection and exchange (1) Structured (IRB) Reliance Agreement based on National IRB reliance models, (2) Study protocols, (3) Structured recruitment materials and (4) Structured informed consent documents and (5) Reportable medical (Unanticipated events, Adverse Events and Serious Adverse Events) and non-medical events and (6) Continuing Review and Final Progress Report form. FHIR resources will be utilized when appropriate. Implementation Guides will be created.

We will review and consider existing standards such as ICSR, other Adverse Event standards (CDISC, ICH E2B) and BRIDG.

Attachments

3b. Project Need

The Common Rule was updated and the necessary standards do not exist to support required data exchange. The vast majority of federally funded research in the United States will require use of a single IRB and will be impacted by the new sIRB Policy. Currently, independent IRB reviews involve redundant work at the local site and local IRB level and inviting the potential for conflicting decisions, requirements and oversight. The new NIH sIRB policy changes this by eliminating the redundancy and opportunity for conflicting reviews, ultimately increasing the efficiency of clinical studies. The creation and implementation of standards will support the new policy. These standards are needed to maintain the rigor of the ethics review while reducing regulatory burden and research costs.

Funding provided by National Center for Advancing Translational Sciences (NCATS)

3c. Security Risk

No

3d. External Drivers

Federal Policy Change- The Common Rule

3e. Objectives/Deliverables and Target Dates


Submit Project Scope Statement -2019 May 23
Gap analysis between needs and existing standards-
2019 March
Development of Implementation Guide/s-
2020 February
Notification of Intent to STU Ballot of Implementation Guide- 2019 December
Ballot Implementation Guide STU- 2020 Jan/May
Ballot Reconciliation- 2020 Jan/May
Request for Publication- 2020 June
Project End Date (all objectives have been met)- 2020 June

3f. Common Names / Keywords / Aliases:

sIRB Project

3g. Lineage

N/A

3h. Project Dependencies

N/A

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/BRR/sIRB+Project+Page

3j. Backwards Compatibility

N/A

3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

3m. External Vocabularies

Unknown

3n. List of Vocabularies

3o. Earliest prior release and/or version to which the compatibility applies

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, White Paper

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

Not Sure at this Time

4c. FHIR Profiles Version

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

White Paper, Implementation Guide (IG) will be created/modified

5a. White Paper Type

Non-balloted WG White Paper

5a. Is the project adopting/endorsing an externally developed IG?

5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

5d. Joint Copyright

No

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

no

6a. External Project Collaboration

National Institute of Health

6b. Content Already Developed

6c. Content externally developed?

6d. List Developers of Externally Developed Content

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6f. Other Stakeholders

6g. Vendors

Pharmaceutical

6g. Other Vendors

6h. Providers

Healthcare Institutions (hospitals, long term care, home care, mental health), Other

6h. Other Providers

Academic Medical Centers (clinical sites) Electronic Data Capture vendors eIRB System vendors, IRB accreditors, IRB Reliance Organizations, Commercial IRBs

6i. Realm

U.S. Realm Specific

7d. US Realm Approval Date

Jun 18, 2019

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

May 21, 2019

7c. Co-Sponsor Approval Date

May 07, 2019

7c. Co-Sponsor 2 Approval Date

May 16, 2019

7c. Co-Sponsor 3 Approval Date

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

7f. FMG Approval Date

May 22, 2019

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date



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