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Good Clinical Practices
  Can EC give approval without reviewing clinical study agreement?,   January 03, 2019
  MBBS physician cannot become investigator for phase I study,   December 04, 2018
  Sponsor should obtain EC related documents from investigator,   October 31, 2018
  EC shall inform licensing authority about cases approved,   October 04, 2018
  Investigator is responsible for rights, health of study subjects,   September 05, 2018
  Material transfer agreement must as per ICMR guidelines,   August 01, 2018
  GDPR regulation enshrines principles of privacy protection,   July 05, 2018
  ICH E6 R2 defines certified copy as a copy of original record,   June 05, 2018
  Indian GCP mandates sponsor should perform audit,   May 02, 2018
  Electronic medical record is a source record,   April 04, 2018
  FDA investigator usually do not review CTA during inspection,   February 28, 2018
  DCGI approval not required for clinical trial of herbal products,   January 31, 2018
  Investigator should not transfer essential documents to sponsor,   January 03, 2018
  Sponsor not responsible for compliance of ethics committee,   December 06, 2017
  Impartial witness is a person who will not be influenced,   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,   September 07, 2017
  Ethics Committee does not work on behalf of sponsor,   August 02, 2017
  As per CDSCO regulation BA/BE data required for new drugs,   July 05, 2017
  Study on behavioral therapy does not require DCGI approval,   May 31, 2017

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