Vulcan - Schedule of Study Activities IG

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