Difference between revisions of "Drug Stability Reporting"
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The intent of this page is to have a repository of documents or artifacts associated with the Drug Stability Reporting (eStability)project. | The intent of this page is to have a repository of documents or artifacts associated with the Drug Stability Reporting (eStability)project. | ||
==Project== | ==Project== | ||
| − | Drug Stability Reporting (eStability) | + | '''Drug Stability Reporting (eStability)''' |
| − | ''Project Number'' | + | ''Project Number'' '''275''' |
| − | ''Project Sponsor(s)'' | + | ''Project Sponsor(s)'' [[Regulated Clinical Research Information Management|RCRIM Work Group]] |
| − | + | ===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. | 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. | ||
Revision as of 17:44, 12 December 2008
Return to RCRIM Page Regulated Clinical Research Information Management
The intent of this page is to have a repository of documents or artifacts associated with the Drug Stability Reporting (eStability)project.
Project
Drug Stability Reporting (eStability)
Project Number 275
Project Sponsor(s) RCRIM Work Group
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
SD Approval Date Mar 28, 2006
TSC Approval Date Apr 21, 2008
PMO Approval Date Apr 23, 2008
Project Type Ballot - DSTU
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
Project Intent Revise Current Standard
Project Intent Notes It is possible that eStability could support the exchange of stability data for drug substances and drug products, including devices, internationally. Collaboration Efforts This project will be sponsored by the US FDA. Dependancies This project will strive to maintain consistency and harmonize with existing or new standards under development. These include: o Structured Product Labeling Standard o Pharmacy Medications DMIM
