Project Summary for 5-year expiration approaching: HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2 (PSS in Confluence)
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Project Details
Number | 1665 View Ballot Items List (with NIBs) |
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Name | 5-year expiration approaching: HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2 (PSS in Confluence) |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | |
Steering Division | None |
Description | Expiration Date: 2021-06-09
Work Group CoChairs need to let HL7 HQ know which of the following actions will be taken: - Reaffirm artifact - Begin work on a new version of the artifact - Withdraw artifact Work Group will reaffirm the artifact. |
Project Facilitator | BRR Co-Chairs |
Status | Archived |
SD Approval Date | Apr 19, 2021 |
TSC Approval Date | Aug 30, 2021 |
Type | Ballot - Normative (no STU) |
Objectives / Deliverables | Expiration Date: 2021-06-09 Work Group CoChairs need to let HL7 HQ know which of the following actions will be taken: - Reaffirm artifact - Begin work on a new version of the artifact - Withdraw artifact Work Group will reaffirm the artifact. |
Next Milestone Date | 2022 January WGM |
Project End Date | 2022 January WGM |
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Project Document Repository |
PSS: https://confluence.hl7.org/display/BRR/HL7+Version+3+Standard%3A+Pharmacovigilance+-+Individual+Case+Safety+Report%2C+Part+2%3A+Human+Pharmaceutical+Reporting+Requirements+for+ICSR%2C+R2 ANSI Standards approaching expiration confluence page: https:... |
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Joint Copyright? | No |
External Pjt Collaborators | |
Realm | Universal |
HL7 Affiliate | |
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Ballot Cycle Info | 2021 Sept Ballot Cycle Info: NORMATIVE Ballot results: Met basic vote requirements. 0 Negatives to reconcile Document Name: Reaffirmation of HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2 |
Misc Notes | 2021 Nov: Received ANSI approval for HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, Release 2. No further work needed from project team. PMO archiving project. 2021 March: BBrodsky: BRR will reaffirm artifact in the Sept 2021 ballot cycle. |
U.S. Govt Interest? | |
USRSC Approval | |
FMG Approval | |
ARB Approval | |
Start Date | Nov 12, 2020 |
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Visit the Projects, Ballots and Standards Metrics Excel Report to view projects that are behind 120+ days along with other ballots and standards requiring a Work Group's attention.
Visit the Projects, Ballots and Standards Metrics Excel Report to view projects that are behind 120+ days along with other ballots and standards requiring a Work Group's attention.