[14.] Kaur S, Choy CY (2014) Ethical considerations in clinical trials: a critique of the ICH-GCP
According to the ICH-GCP
, researchers and pharmaceutical sponsors must abide by the laws of the country and other applicable local and international guidelines when conducting their research.
The questionnaire consisted of twenty multiple-choice questions type on basic principles of Good Clinical Practice in clinical research methodology based on the 1990 European GCP guidelines particularly ICH-GCP
The other declared its loyalty for Health Canada, which dwelled in the land of ICH-GCP. It implored for more placebos.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use's Guideline for Good Clinical Practice (ICH-GCP) permits use of placebo controls except where permanent or serious harm is anticipated.
Accordingly, the FDA now considers it sufficient that a trial performed outside USA soil adhere to the Good Clinical Practices of the International Conference of Harmonization (ICH-GCP).
The 2008 revision of the DoH (5) is more ethically demanding than the ICH-GCP, and addresses moral issues that the ICH-GCP guidelines do not.
Not all CROs, however, are strict on sticking to every detail of ICH-GCP
norms, especially the ones operating within the boundaries of the country.
The trial is an open-label Phase II ICH-GCP
compliant trial involving 30 patients with anemia, across 6 trial centres in India.
For instance, more information on good clinical practice can be found in "Good Clinical Practices" (GCP) guideline, also known as the ICH-GCP
Guideline, which Health Canada introduced into its framework as a "guidance document".