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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

2b. Co-Sponsor WG 2

Patient Care

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

2b. Co-Sponsor WG 3

FHIR Infrastructure

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Mike Ward (HL7 member?)

2e. Other Interested Parties (and roles)

2f. Modeling Facilitator

Geoff Low (HL7 member?)

2g. Publishing Facilitator

2h. Vocabulary Facilitator

2i. Domain Expert Representative

Mike Ward (HL7 member?) Others ??

2j. Business Requirements Analyst

??

2k. Conformance Facilitator

??

2l. Other Facilitators

2m. Implementers

??
??

3a. Project Scope

1) Representation of activities in Regulated clinical trials of medicinal products in human subjects
2) Linkage of the planned activities to actual patient treatment plans and records

Attachments

3b. Project Need

Currently each software package used in the study holds its own representation of that schedule. This leads to repeated entry of the schedule frequently leading to differences in naming for a given event and omission of other events. Management and reporting of data during a study and subsequent aggregation of data are made more difficult.

Adoption of a FHIR based representation of the schedule will introduce consistency and avoid repeated data entry.

3c. Security Risk

No

3d. External Drivers

Vulcan Accelerator Project

3e. Objectives/Deliverables and Target Dates

First review WGM May 2022

3f. Common Names / Keywords / Aliases:

SoA IG

3g. Lineage

??

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/Vulcan-schedule-ig

3j. Backwards Compatibility

No

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

Yes

3n. List of Vocabularies

TBD - there are established vocabularies for some of the stages of a study that may be appropriate

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

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles

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

R4 and above

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

STU to Normative

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

Regulatory Agency

6f. Other Stakeholders

EHR and Trial Management system vendors

6g. Vendors

Pharmaceutical, EHR, PHR, Clinical Decision Support Systems, Other

6g. Other Vendors

Trial management system vendors

6h. Providers

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

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

Modify Date

Jun 23, 2021 16:49

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

2b. Co-Sponsor WG 2

Patient Care

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

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Mike Ward (HL7 member?)

2f. Modeling Facilitator

Geoff Low (HL7 member?)

2i. Domain Expert Representative

Mike Ward (HL7 member?) Others ??

2j. Business Requirements Analyst

??

2k. Conformance Facilitator

??

2m. Implementers

??
??

3a. Project Scope

1) Representation of activities in Regulated clinical trials of medicinal products in human subjects
2) Linkage of the planned activities to actual patient treatment plans and records

3b. Project Need

Currently each software package used in the study holds its own representation of that schedule. This leads to repeated entry of the schedule frequently leading to differences in naming for a given event and omission of other events. Management and reporting of data during a study and subsequent aggregation of data are made more difficult.

Adoption of a FHIR based representation of the schedule will introduce consistency and avoid repeated data entry.

3c. Security Risk

No

3d. External Drivers

Vulcan Accelerator Project

3e. Objectives/Deliverables and Target Dates

First review WGM May 2022

3f. Common Names / Keywords / Aliases:

SoA IG

3g. Lineage

??

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/Vulcan-schedule-ig

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

N/A

3m. External Vocabularies

Yes

3n. List of Vocabularies

TBD - there are established vocabularies for some of the stages of a study that may be appropriate

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles

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

R4 and above

5a. Project Intent

Implementation Guide (IG) will be created/modified

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

No

5b. Project Ballot Type

STU to Normative

6f. Stakeholders

Regulatory Agency

6f. Other Stakeholders

EHR and Trial Management system vendors

6g. Vendors

Pharmaceutical, EHR, PHR, Clinical Decision Support Systems, Other

6g. Other Vendors

Trial management system vendors

6h. Providers

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

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR