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 Premier Research India
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Good Clinical Practices
  Patients’ travel expenses need review and approval from Ethics Committee,   September 01, 2022
  Review of source data is critical to ensure quality of trial conduct,   August 03, 2022
  It is mandatory to notify CDSCO about protocol deviations,   June 01, 2022
  Non-interventional study for active surveillance needs CDSCO nod,   May 04, 2022
  It is not mandatory to provide results of clinical trial in CTRI,   April 06, 2022
  Investigator can archive records at a location outside institution,   March 01, 2022
  No specific norms describe family volunteering in a clinical trial,   February 01, 2022
  Usability studies assess ability of future participants for using DHT,   January 05, 2022
  Investigational product should be suitable for delivery to participant,   December 01, 2021
  Regulatory GCP inspections identify many gaps in clinical trial contracts,   November 03, 2021
  Investigator can allow for remote SDV by ensuring proper measures,   October 06, 2021
  Signature of sponsor is not essential on clinical trial agreement,   September 01, 2021
  Ethics Committee approval is required for all real-world studies,   August 04, 2021
  Documents on e-TMF should remain complete and legible,   June 30, 2021
  Sharing of raw data by Indian PI with foreign agency not permitted,   June 02, 2021
  Source data includes info in original records, certified copies of findings,   May 05, 2021
  Effectiveness of a vaccine is capability to produce desired effect,   March 31, 2021
  Bioequivalence study should not be conducted in illiterate volunteers,   March 03, 2021
  Plant-based extracts are not considered as new drugs,   February 03, 2021
  ICMR guidelines are applicable for investigator initiated studies,   December 02, 2020

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