Recently GCP training is mandated for all researchers proposing to do clinical research? Who could impart GCP training? is there any official document specifying the qualifications of the trainer and the topics to be covered in training?
Now a days it is mandatory to have GCP training if you are involved in conducting clinical trials. Your roles and responsibilities may varies for example as PI, Sub-I or CRC. To the best of my knowledge it is not mentioned anywhere who can impart GCP training but ideally it should be provided by experienced and qualified professional. In the same way, GCP training should includes all relevant major sections pertaining to E6 guidelines as ICF process, safety reporting, Investigator's responsibilities, ethics committee, protocol compliance, IP, medical care of trial subjects etc.
I do not know your training options in India. In the U.S., the FDA provides GCP training and uses various organizations to conduct GCP training. I insert below a link to the FDA webpage listing workshops and meetings specific to GCP training. My hope is that you can find an organization that includes your country.
Many training programs have been cancelled or postponed due to the coronavirus impact on many countries. If I can locate a training program in India, or a company with qualified trainers willing to travel to India, I will contact you further. Good luck! --cc
https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/workshops-and-meetings
I cannot direct you to a document specific to India, but I located an organization in India that provides GCP training. See the link below.
https://igmpiindia.org/good-clinical-practices.html
To my knowledge there are no specific guidelines on the requirements for a GCP trainer. GCP training should include contents of ICHE6- R2 guidelines. It would be worth looking at the transcelerate minimum criteria on the GCP Training.
http://www.transceleratebiopharmainc.com/wp-content/uploads/2017/03/GCP-MR-Minimum-Criteria-R2_FINAL.pdf
- Badges
- Science topic
- Similar topics
- Geoscience
- Asia
- India