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
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 Decision Support
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 Update Periods
Monthly
2d. Project Facilitator
Hugh Glover
2e. Other Interested Parties (and roles)
This is a Vulcan Accelerator project
2f. Modeling Facilitator
TBD
2g. Publishing Facilitator
Hugh Glover
2h. Vocabulary Facilitator
TBD
2i. Domain Expert Representative
TBD
2j. Business Requirements Analyst
TBD
2k. Conformance Facilitator
TBD
2l. Other Facilitators
2m. Implementers
1. TBD
2. TBD
3a. Project Scope
FHIR Representation of planned activities in a Regulated Clinical Study- what are usually described as "visits" in the approved protocol for the study
Attachments
3b. Project Need
Without an IG there are multiple ways that might be adopted for representation of the planned activities. This would be a problem for interoperability.
3c. Security Risk
No
3d. External Drivers
This is a Vulcan Accelerator project
3e. Objectives/Deliverables and Target Dates
3f. Common Names / Keywords / Aliases:
3g. Lineage
3h. Project Dependencies
3i. HL7-Managed Project Document Repository URL:
3j. Backwards Compatibility
No
3k. Additional Backwards Compatibility Information (if applicable)
3l. Using Current V3 Data Types?
3l. Reason for not using current V3 data types?
3m. External Vocabularies
3n. List of Vocabularies
3o. Earliest prior release and/or version to which the compatibility applies
4a. Products
4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?
4c. FHIR Profiles Version
4d. Please define your New Product Definition
4d. Please define your New Product Family
5a. Project Intent
Implementation Guide (IG) will be created/modified
5a. White Paper Type
5a. Is the project adopting/endorsing an externally developed IG?
No
5a. Externally developed IG is to be (select one)
5a. Specify external organization
5a. Revising Current Standard Info
5b. Project Ballot Type
5c. Additional Ballot Info
5d. Joint Copyright
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
6b. Content Already Developed
6c. Content externally developed?
6d. List Developers of Externally Developed Content
6e. Is this a hosted (externally funded) project?
6f. Stakeholders
6f. Other Stakeholders
6g. Vendors
6g. Other Vendors
6h. Providers
6h. Other Providers
6i. Realm
Universal
7d. US Realm Approval Date
7a. Management Group(s) to Review PSS
FHIR
7b. Sponsoring WG Approval Date
7c. Co-Sponsor Approval Date
7c. Co-Sponsor 2 Approval Date
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
7g. V2 MG Approval Date
7h. Architecture Review Board Approval Date
7i. Steering Division Approval Date
7j. TSC Approval Date
Show Changes
Version
1
Modifier
Hugh Glover
Modify Date
Feb 17, 2021 20:23
1a. Project Name
Vulcan - Schedule of Study Activities IG
1c. Is Your Project an Investigative Project (aka PSS-Lite)?
No
1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?
No
2a. Primary/Sponsor WG
Biomedical Research & Regulation
2b. Co-Sponsor WG
Clinical Decision Support
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 Update Periods
Monthly
2d. Project Facilitator
Hugh Glover
2e. Other Interested Parties (and roles)
This is a Vulcan Accelerator project
2f. Modeling Facilitator
TBD
2g. Publishing Facilitator
Hugh Glover
2h. Vocabulary Facilitator
TBD
2i. Domain Expert Representative
TBD
2j. Business Requirements Analyst
TBD
2k. Conformance Facilitator
TBD
2m. Implementers
1. TBD
2. TBD
3a. Project Scope
FHIR Representation of planned activities in a Regulated Clinical Study- what are usually described as "visits" in the approved protocol for the study
3b. Project Need
Without an IG there are multiple ways that might be adopted for representation of the planned activities. This would be a problem for interoperability.
3c. Security Risk
No
3d. External Drivers
This is a Vulcan Accelerator project
3j. Backwards Compatibility
No
5a. Project Intent
Implementation Guide (IG) will be created/modified
5a. Is the project adopting/endorsing an externally developed IG?