Project Summary for Drug Stability Reporting (eStability)
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Project Details
Number | 275 View Ballot Items List (with NIBs) |
---|---|
Name | Drug Stability Reporting (eStability) |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | |
Steering Division | Clinical |
Description | The project scope is to ballot a HL7 V3 Drug Stability Reporting (eStability) Release 2 Draft Standard for Trial Use (DSTU) message and the Implementation Guide (IG). The HL7 V3 Drug Stability Reporting (eStability) Release 1 is an approved HL7 and ANSI standard. Based on information gathered during the FDA pilot of Release 1 the message and IG were revised and Release 2 was proposed to be balloted as a DSTU. The scope includes: - Completion of DSTU testing and incorporation of changes or new requirements identified through DSTU testing. - Completion of IG. |
Project Facilitator | Norman Gregory |
Status | Archived |
SD Approval Date | Mar 28, 2006 |
TSC Approval Date | Apr 21, 2008 |
Type | Ballot - Normative (no STU) |
Objectives / Deliverables | The goal of this project is to develop a method to provide stability data in a standard electronic format so that it may be viewed as it appears on paper or electronic paper by regulatory agencies and industry. Target: Normative Ballot of Release 2 January 2009 |
Next Milestone Date | 2012 September WGM |
Project End Date | 2012 September WGM |
Project Intent | Revise Current Standard |
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Dependancies | This project will strive to maintain consistency and harmonize with existing or new standards under development. These include: - Structured Product Labeling Standard - Pharmacy Medications DMIM |
Project Document Repository |
http://wiki.hl7.org/index.php?title=Drug_Stability_Reporting; http://www.estability.org/ |
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External Pjt Collaborators | This project will be sponsored by the US FDA. |
Realm | - Choose One - |
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Ballot Cycle Info | 2011 May Ballot Cycle Info: INFORMATIVE Ballot results: Met basic vote requirements. 0 Negatives to reconcile Document Name: HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 2 Ballot ID: V3_IG_DSRR2_R2_I2_2011MAY NIB Submitted By: Edward Tripp 2010 Sept Ballot Cycle Info: INFORMATIVE Ballot results: Met basic vote requirements. 1 Negative votes to reconcile Document Name: HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 2 Last Ballot Code: V3_IG_DSRR2_R2_TBD NIB Submitted By: Edward Tripp 2010 May Ballot Cycle Info: NORMATIVE Ballot results: Met basic vote requirements for approval. 2 Negative votes to reconcile Document Name: HL7 Version 3 Standard: Drug Stability Reporting (eStability), Release 2 Ballot Code: V3_DSR_R2_D2_2009JAN NIB Submitted By: Edward Tripp |
Misc Notes | Sept 2012: 2012 NE published. Archived project. Feb 2012: PMO set status to Ready for NE (only HQ work remains; the project team is reviewing the updated Product Brief Lynn sent them but doesn't have any other work to do for this project) Dec 2011: TSC approved the request for publication. Nov. 2011: a request for the publication of an informative document that will be coming to the TSC for approval. HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 2 at TSC Tracker # 2125. August 2011: Don published; noted that it is R2. Archiving project. June 2011: received ANSI approval. PMO changed status to "Ready for NE". No more work necessary from the Project Team; remaining work is HL7 HQ work. April 2011: submitted to ANSI for approval. Nov 2010: The TSC approved the following request to publish an Informative Document: HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 2, for RCRIM WG, at TSC Tracker # 1682. Based on information gathered during the FDA pilot of Release 1 the message and IG were revised and Release 2 was balloted as a DSTU last May. 2010July: updated project repository URLs Feb 28, 2010 - DSTU Expired for: HL7 Version 3 Standard: Drug Stability Reporting (eStability), Release 2 |
U.S. Govt Interest? | |
USRSC Approval | |
FMG Approval | |
ARB Approval | |
Start Date | Mar 24, 2008 |
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