ICH Good Clinical Practice (GCP) E6(R2)
(Redirected from ICH Good Clinical Practice E6 R2)
Jump to navigation
Jump to search
A ICH Good Clinical Practice (GCP) E6(R2) is a Good Clinical Practice proposed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- See: ALCOA+.
REferences
2020
- https://www.ich.org/page/efficacy-guidelines
- QUOTE: ... The first version of the ICH E6 Good Clinical Practice (GCP) Guideline was finalised in 1996 describing the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCP covers aspects of monitoring, reporting and archiving of clinical trials, and incorporates addenda on the Essential Documents and on the Investigator's Brochure.
This Harmonised Guideline has been amended in 2016 with an integrated Addendum to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting, while continuing to ensure human subject protection and reliability of trial results. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated. ...
- QUOTE: ... The first version of the ICH E6 Good Clinical Practice (GCP) Guideline was finalised in 1996 describing the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCP covers aspects of monitoring, reporting and archiving of clinical trials, and incorporates addenda on the Essential Documents and on the Investigator's Brochure.