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Template Usage Information:

  1. Project Name and ID



Enter the name of the project here: Single Institutional Review Board Project (sIRB)

Project ID: 1540

Complete this section for all “Direct to Normative” ballot projects and when a project proceeds from “Informative to Normative” or “STU to Normative”.

Forward PSS to the TSC (via tscpm@HL7.org); this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.

 

TSC Notification:  Informative/STU to Normative 

Date:  Submission date


- or -                     Direct to Normative (no STU) (includes reaffirmations)       

 

Identify ISO, IEC or ISO/IEC standard to be adopted in text box below

Enter info here if an ISO, IEC, or ISO/IEC Standard is to be adopted as an American National Standard; Enter the designation of the standard(s) to be adopted:

Includes text from ISO, IEC or ISO/IEC standard: Check here if this standard includes excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption.

Yes

 

No

Select the unit of measure used in the standard; if no measurements are in the standard, select N/A

 

N/A

x 

U.S.

Metric

 

Both

 

Investigative Project (aka PSS-Lite)

Date : 

Check this box when the project is investigative or exploratory in nature, which allows limited project scope definition. Sections 1-Project Name, 2-Sponsoring Group(s)/Project Team, 3a-Project Scope, 3b-Project Need, 3e-Project Objectives/Deliverables/Target Dates, 3i-Project Document Repository, 6b-[Realm, if known], and 6d-[applicable Approval Dates] are required for Investigative Project. Investigative Project specific instructions are highlighted in yellow. An investigative project must advance in two WGM cycles, requiring a full scope statement. Otherwise the project will be closed.

2. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

Primary Sponsor/Work Group
(1 (And Only 1) Allowed)

Biomedical Research and Regulation (BR&R)

2.b. Co-sponsor Work Group(s)

Co-sponsor Work Group(s):

(Enter co-sponsor approval dates in Section 6.d Project Approval Dates)

Clinical Interoperability Council (CIC)

FHIR Infrastructure

Indicate the level of involvement that the co-sponsor will have for this project:
? Request formal content review prior to ballot
X Request periodic project updates. Specify periodMonthly & WGS
 Other Involvement. Specify details here: 

2.c. Project Team

All names should have confirmed their role in the project prior to submission to the TSC.

Project facilitator (1Mandatory)

Ed Hammond

Other interested parties and their 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

Multi-disciplinary project team (recommended)


FHIR FacilitatorEd Hammond (Jean Duteau)

     Modeling facilitator

Michael Rutherford

     Publishing facilitator

James Topping

     Vocabulary facilitator

Julie James

     Domain expert rep

Meredith Zozus

     Business requirement analyst

James Topping

     Conformance facilitator (for IG projects)

Michael Rutherford

     Other facilitators (SOA, etc)




Implementers (2Mandatory for STU projects)

FHIR Project Note: The implementer requirement will be handled by the “balloting” project.  Therefore work groups do not fill out the above section.  However, feel free to list implementer specific to your work group’s resources if you know of any.

1) Duke University

2) University of Arkansas for Medical Sciences

3) Vanderbilt University

3. Project Definition

3.a. Project Scope


Describe the project; include what is expected to be accomplished/delivered along with specified features and functions. Include whether the deliverable(s) are universal, realm specific or applicable to various realms. Be sure to spell out all acronyms as these are carried forward to the NIB (Notice of Intent to Ballot) for ballot announcements..

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 Determination Letter 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.

3.b. Project Need


This information is required by ANSI for all ballots. Briefly explain the reason behind the need for this project. This may be related to legislative requirements, industry need, or similar justifications.
.

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)

3.c. Security Risks


Will this project produce executable(s), for example, schemas, transforms, style sheets, executable program, etc.  If so the project must review and document security risks. Refer to the Cookbook for Security Considerations for additional guidance, including sample spreadsheets that may be used to conduct the security risk assessment. 

Yes

X

No

Unknown


3.d. External Drivers


Describe any external schedules or calendars which may not be known outside of the project team that are driving target dates for this project..

Federal Policy Change- The Common Rule

3.e. Project Objectives / Deliverables / Target Dates

Within each row, enter the explicit work product(s) / objective(s).  Indicate their target date at the right in WGM/Ballot Cycle format. 
Include the project end date as the last objective (for standards projects, the end date will be the projected ANSI approval date). 

Target Date(in WGM or ballot cycle format, e.g.
‘2017 Sept WGM’ or
‘2017 Jan Ballot’)

Submit Project Scope Statement

2019 May 23

Gap analysis between needs and existing standards

2020 February

Development of Implementation Guide/s

2020 March

Host Connect-a-thon2020 May

Notification of Intent to STU Ballot of Implementation Guide

2020 July

Ballot Implementation Guide STU

2020 July

Ballot Reconciliation

2020 July/August

Request for Publication

2020 Oct

Project End Date (all objectives have been met)
Note:  For PSS-Lite/Investigative Project, End date must be no more than two WGM cycles, e.g. project initiated at January WGM must complete investigation by September WGM.

2020 Oct


3.f.   Common Names / Keywords / Aliases


What common name does your group use to refer to the product(s) produced?  What alternative names, aliases and keywords does your group use to refer to the product(s) that will be produced?  Some examples: C-CDA, LRI, eDOS. 

sIRB Project

3.g. Lineage


If your project creates a Post-Release 1 version; indicate the name of the prior product and if it is supplanting, replacing or coexisting with a previous release:

n/a

3.h. Project Dependencies


Enter any dependencies or the name & Project Insight ID of project(s) that this project is dependent upon to achieve its objectives:
 

Projects and their Project Insight IDs can be found via http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?ref=common

n/a

3.i.   HL7-Managed Project Document Repository Location


Projects must adhere to the TSC's guidelines (which were approved on 2016-04-04 and summarized in Appendix A).

A template to create a Project Page on the HL7 Wiki is available at: http://wiki.hl7.org/index.php?title=Template:Project_Page.

Enter the SPECIFIC URL of the HL7-MANAGED SITE where supporting project documents, deliverables, ballot reconciliation work and other project information will be kept. 
sIRB Project Page


3.j.   Backwards Compatibility


Are the items being produced by this project backward compatible?


Yes


No


Unknown

X

N/A

If you check 'Yes' please indicate the earliest prior release and/or version to which the compatibility applies:


For V3, are you using the current data types? 

(Refer to TSC position statement on new projects using R2B for more information on the current V3 data types)


Yes


No


Unknown

X

N/A



If you check no, please explain the reason:

If desired, enter additional information regarding Backwards Compatibility.


3.k. External Vocabularies


Will this project include/reference external vocabularies?


Yes


No

X

Unknown


N/A

If Yes, please enter the vocabularies:


4. Products (check all that apply)



Arden Syntax


V2 Messages – Administrative


Clinical Information Modeling Initiative (CIMI)


V2 Messages - Clinical


Clinical Context Object Workgroup (CCOW)


V2 Messages - Departmental


Domain Analysis Model (DAM)


V2 Messages – Infrastructure


Electronic Health Record (EHR) Functional Profile


V3 Domain Information Model (DIM / DMIM)

X

FHIR Extensions


V3 Documents – Administrative (e.g. SPL)

X

FHIR Implementation Guide (enter FHIR product version below)


V3 Documents – Clinical (e.g. CDA)

X

FHIR Profiles (enter FHIR product version below)


V3 Documents - Knowledge


FHIR Resources


V3 Foundation – RIM


Guidance (e.g. Companion Guide, Cookbook, etc)


V3 Foundation – Vocab Domains & Value Sets


Logical Model


V3 Messages - Administrative


New/Modified/HL7 Policy/Procedure/Process


V3 Messages - Clinical


New Product Definition (please define below)


V3 Messages - Departmental


New Product Family (please define below)


V3 Messages - Infrastructure


Non Product Project - (Educ. Marketing, Elec. Services, etc.)


V3 Rules - GELLO

X

White Paper


V3 Services – Java Services (ITS Work Group)


Creating/Using a tool not listed in the HL7 Tool Inventory


V3 Services – Web Services (SOA)

If you checked New Product Definition or New Product Family, please define below:


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

R4


5. Project Intent (check all that apply)




Create new standard


x

Supplement to a current standard


Revise current standard (see text box below)


x

Implementation Guide (IG) will be created/modified


Reaffirmation of a standard



Project is adopting/endorsing an externally developed IG:


New/Modified HL7 Policy/Procedure/Process



Specify external organization in Sec. 6 below;





Externally developed IG is to be (select one):


White Paper (select one):



Adopted  - OR -


Endorsed



Balloted Informative OR

X

Non-balloted WG White Paper



N/A  (Project not directly related to an HL7 Standard)











If revising a current standard, indicate the following:


-    Name of the standard being revised:
-    Date it was published (or request for publication, or ANSI designation date)
-    Rationale for revision
-    The relationship between the new standard and the current standard (is it designed to replace the current standard, a supplement to the current standard, etc.)


5.a. Ballot Type (check all that apply)



Comment (aka Comment-Only)



Joint Ballot (with other SDOs)

x

Informative



N/A  (project won’t go through ballot)


STU to Normative     - OR -


Normative (no STU)











If necessary, add any additional ballot information here.  If artifacts will be jointly balloted with other SDOs, list the other groups.

We are also open to doing a "Comment Only" ballot because this is a unique application and our main objective this phase is to demonstrate progress and feedback as we move forward.


5.b. Joint Copyright

Check this box if you will be pursuing a joint copyright.  Note that when this box is checked, a Joint Copyright Letter of Agreement must be submitted to the TSC in order for the PSS to receive TSC approval.

Joint Copyrighted Material will be produced?



Yes

X

No


6. Project Logistics

6.a. External Project Collaboration


Include SDOs or other external entities you are collaborating with, including government agencies as well as any industry outreach.  Indicate the nature and status of the Memorandum of Understanding (MOU) if applicable.

For projects that have some of their content already developed:

How much content for this project is already developed?

Was the content externally developed ? :

Y/N

Is this a hosted (externally funded) project?  (not asking for amount just if funded)

X

Yes


No


6.b. Realm


Universal 

- OR -

 X

Realm Specific



 

Check here if this standard balloted or was previously approved as realm specific standard

US - because this project is supported by the National Institute of Health

Enter “U.S.” or name of HL7 affiliate(s) here.  Provide explanation/justification of realm selection. For projects producing deliverables applicable to multiple realms, document those details here. "U.S." 

For Investigative projects, indicate if the project is planned to be Realm Specific or Universal, if known. Work Groups are encouraged designating project a Universal project initially, and discover which Realms can contribute to the work effort during the discovery phase of the project. Note: This status is subject to change during the investigative process.

"U.S." 


6.c. Stakeholders / Vendors / Providers

This section must be completed for projects containing items expected to be ANSI approved, as it is an ANSI requirement for all ballots

 

Stakeholders

 

Vendors

 

Providers

 

Clinical and Public Health Laboratories

 X 

Pharmaceutical

  

Clinical and Public Health Laboratories

  

Immunization Registries

  

EHR, PHR

  

Emergency Services

  

Quality Reporting Agencies

  

Equipment

  

Local and State Departments of Health

X  

Regulatory Agency

  

Health Care IT

  

Medical Imaging Service

X  

Standards Development Organizations (SDOs)

  

Clinical Decision Support Systems

 X 

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

  

Payors

  

Lab

 X 

Other (specify in text box below)

  

Other (specify in text box below)

  

HIS

  

N/A

  

N/A

  

Other (specify below)


 

 


  

N/A

 

 


Other:  Indicate other stakeholders, vendors or providers not listed above.

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









6.d. Project Approval Dates

Click here to go to HL7 Project Scope Statement Instructions#Appendix A for more information regarding this section.
Approvals are by simple majority vote of the approving body

Sponsoring Work Group Approval Date:

WG Approval Date

2019-05-21

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date


List each Co-Sponsor and their Approval Date

CIC: 2019-05-07
FHIR_I 2019-05-16

Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

CIMI MG Approval Date

N/A

CDA Projects: CDA Management Group

CDA MG Approval Date

N/A

FHIR Projects: FHIR Management Group

FMG Approval Date

2019-05-22

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date

N/A

US Realm Projects: US Realm Steering Committee Approval
(Email WG approved PSS to: tscpm@HL7.org)

USRSC Approval Date

2019-06-18

Affiliate Specific Projects: Affiliate Approval Date

Affiliate Approval Date

N/A

Submit PSS to Steering Division after all of the above approvals are received

Steering Division (of Primary Sponsor WG) Approval Date:

SD Approval Date CCYY-MM-DD

2019-11-22

Last PBS Metrics Score:

X

 Green

 Yellow

 Red

PBS Metrics Reviewed? (required for SD Approval if not green)

 Yes

 No

ARB and Steering Division approval may be in parallel

Architectural Review Board Approval Date:

(required for externally developed content)

ARB Approval Date

N/A

TSC Approval

If applicable, TSC has received a Joint Copyright/Distribution Agreement (containing the verbiage outlined within the SOU),
signed by both parties.

Yes

No

X

 N/A


Technical Steering Committee Approval Date:
(Email SD WG approved PSS to: tscpm@HL7.org)

TSC Approval Date

2019-12-02