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Good Clinical Practices
  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
  Investigator should follow trial's randomization procedures,   May 03, 2017
  US FDA do not prohibit use of MS Excel for data management,   April 05, 2017
  EC approval needed for content of recruitment website,   March 01, 2017
  Lay person should fit criteria provided by ICMR norms,   February 01, 2017
  AV consent should be maintained by investigator for record,   January 04, 2017
  How long a participant should be monitored for AE/SAE?,   November 30, 2016
  In paediatric clinical studies EC should include paediatrician,   November 02, 2016
  In Indian regulations, there is no provision for alternative to face-to-face consent,   October 05, 2016

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