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Good Clinical Practices
  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
  Real World Evidence studies need review by Ethics Committee,   November 04, 2020
  Serious adverse event occurs to trial subject during clinical trial,   September 30, 2020
  During COVID-19 pandemic, monitor can review source documents if the site can set up remote viewing portal,   September 02, 2020
  During pandemic, regulator allows changes to investigational plan without prior review to eliminate hazard for the participants,   August 06, 2020
  Indian investigator can conduct international survey approved by EC,   July 02, 2020
  ICMR allows use of electronic process during COVID-19 pandemic,   June 06, 2020
  Protection of rights & safety of trial subjects are important,   May 08, 2020
  Investigator should maintain essential documents,   March 04, 2020
  US FDA prescribes situations for black box warning,   February 05, 2020
  No limit on number of clinical trials one investigator can do,   December 31, 2019
  Clinical trial on herbal extract could be conducted using classical preparations,   December 04, 2019

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