Buena práctica clínica
The tripartite harmonised ICH Guideline was finalised underPaso 4 En Mayo 1996. Este documento de Buenas Prácticas Clínicas describe las responsabilidades y expectativas de todos los participantes en la realización de ensayos clínicos., 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.
Paso 5
UE:
Adopted by CPMP, Julio 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 Puede 1997, Vol. 62, No. 90, p. 25691-25709
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