1a. Project Name

Vulcan - Schedule of Study Activities IG

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

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



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?

No

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR