ICH-GCP refers to Guideline E6(R1): Good Clinical Practice : Consolidated Guideline, prepared by the International Conference of Harmonisation.
It was finalised in May 1996 and describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs (ethics committees). GCPs cover aspects of monitoring, reporting and archiving of clinical trials, and Essential Documents.
Revision1
yes
yes
E6 refers to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Good Clinical Practice (GCP). This guideline sets out the standards for designing, conducting, recording, and reporting clinical trials involving human subjects. It ensures that the rights, safety, and well-being of trial participants are protected, and that the data generated is reliable and credible.
ICH has its guidelines divided into 4 categories. The 4 categories are Quality Guidelines, Safety Guidelines, Efficacy Guidelines and Multidisciplinary Guidelines.
the same guidelines for method validation
no
GMP as per ICH guidelines Good Manufacturing Practices .
Adrian homer
It depends you guys is there a GCP in your state.
Ich bin was ich bin = I am what I am.
ich bin ich bin ich makes little sense but translates as I am I am me.