Good Clinical Practices

ICH E6 R2 defines certified copy as a copy of original record

Dr Arun Bhatt | June 05, 2018

Indian GCP mandates sponsor should perform audit

Dr Arun Bhatt | May 02, 2018

Electronic medical record is a source record

Dr Arun Bhatt | April 04, 2018

FDA investigator usually do not review CTA during inspection

Dr Arun Bhatt | February 28, 2018

DCGI approval not required for clinical trial of herbal products

Dr Arun Bhatt | January 31, 2018

Investigator should not transfer essential documents to sponsor

Dr Arun Bhatt | January 03, 2018

Sponsor not responsible for compliance of ethics committee

Dr Arun Bhatt | December 06, 2017

Impartial witness is a person who will not be influenced

Dr Arun Bhatt | November 08, 2017

AV recording of ICP mandatory for vulnerable subject in trials

October 05, 2017

AV recording cannot be discontinued for vulnerable subject in clinical trials

Dr Arun Bhatt | September 07, 2017

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