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Good Clinical Practices
  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
  Essential documents should be retained at least 2 years,   August 31, 2016
  CDSCO rules for SAE do not differentiate between trials, study,   August 03, 2016
  EC can't review study protocol without prior registration with CDSCO,   July 06, 2016
  DCGI approval required for trial of new topical formulation,   May 31, 2016
  Judgement of investigator is final on SAE/AE,   May 04, 2016
  DCGI approval not required for clinical trial of herbal products,   April 06, 2016
  Can pharmacologist conduct BA/BE/PK study in paediatrics?,   March 03, 2016
  For clinical studies in children investigator must be paediatrician,   February 03, 2016
  Adverse events to be documented and assessed by investigator,   January 06, 2016

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