Do not launch ANY of the links while your are in create or edit mode. There is a good chance all of your work will be gone.
Template Usage Information:
- Submit template change requests to PMO@HL7.org
- For Reaffirmations, please refer to the FAQ in Hl7 Project Scope Statement Instructions for a list of which sections and fields should be completed
Project Name and ID
Enter the name of the project here: Single Institutional Review Board Project (sIRB)
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.
Select the unit of measure used in the standard; if no measurements are in the standard, select N/A
Investigative Project (aka PSS-Lite)
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
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)
|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 period||Monthly & 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)
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 Facilitator||Ed Hammond (Jean Duteau)|
Domain expert rep
Business requirement analyst
Conformance facilitator (for IG projects)
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.
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.
Target Date(in WGM or ballot cycle format, e.g.
Submit Project Scope Statement
2019 May 23
Gap analysis between needs and existing standards
Development of Implementation Guide/s
|Host Connect-a-thon||2020 May|
Notification of Intent to STU Ballot of Implementation Guide
Ballot Implementation Guide STU
Request for Publication
Project End Date (all objectives have been met)
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.
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:
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
3.i. HL7-Managed Project Document Repository Location
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?
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)
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?
If Yes, please enter the vocabularies:
4. Products (check all that apply)
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)
V3 Documents – Administrative (e.g. SPL)
FHIR Implementation Guide (enter FHIR product version below)
V3 Documents – Clinical (e.g. CDA)
FHIR Profiles (enter FHIR product version below)
V3 Documents - Knowledge
V3 Foundation – RIM
Guidance (e.g. Companion Guide, Cookbook, etc)
V3 Foundation – Vocab Domains & Value Sets
V3 Messages - Administrative
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
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?
5. Project Intent (check all that apply)
Create new standard
Supplement to a current standard
Revise current standard (see text box below)
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 -
Balloted Informative OR
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)
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?
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 ? :
Is this a hosted (externally funded) project? (not asking for amount just if funded)
- OR -
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.
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
Clinical and Public Health Laboratories
Clinical and Public Health Laboratories
Quality Reporting Agencies
Local and State Departments of Health
Health Care IT
Medical Imaging Service
Standards Development Organizations (SDOs)
Clinical Decision Support Systems
Healthcare Institutions (hospitals, long term care, home care, mental health)
Other (specify in text box below)
Other (specify in text box below)
Other (specify below)
Other: Indicate other stakeholders, vendors or providers not listed above.
Academic Medical Centers (clinical sites),
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
Administrative review – in parallel with Work Group Approval
Co-Sponsor Group Approval Date
List each Co-Sponsor and their Approval Date
Family Management Group Approval Date(s)
CIMI Projects: CIMI Management Group
CIMI MG Approval Date
CDA Projects: CDA Management Group
CDA MG Approval Date
FHIR Projects: FHIR Management Group
FMG Approval Date
V2/Publishing Projects: V2 Management Group
V2 MG Approval Date
US Realm Projects: US Realm Steering Committee Approval
USRSC Approval Date
Affiliate Specific Projects: Affiliate Approval Date
Affiliate Approval Date
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
ARB and Steering Division approval may be in parallel
Architectural Review Board Approval Date:
(required for externally developed content)
ARB Approval Date
If applicable, TSC has received a Joint Copyright/Distribution Agreement (containing the verbiage outlined within the SOU),
Technical Steering Committee Approval Date:
TSC Approval Date