Good Clinical Practice
The tripartite harmonised ICH Guideline was finalised under Step 4 in May 1996. This Good Clinical Practices document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCPs cover aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator’s Brochure which had been agreed earlier through the ICH process.
Step 5
EU:
Adopted by CPMP, July 1996, issued as CPMP/ICH/135/95/Step5, Explanatory Note and Comments to the above, issued as CPMP/768/97
MHLW:
Adopted March 1997, PAB Notification No. 430, MHLW Ordinance No. 28
FDA:
Published in the Federal Register, 9 May 1997, Vol. 62, No. 90, p. 25691-25709
Interested in learning whether current clinical programs, research developments, or emerging therapeutic approaches may be relevant to your situation?
Educational and research information only. Individual medical decisions should be made in consultation with qualified healthcare professionals.
0 Comments