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Good Clinical Practices
  Sponsor is responsible for validation of clinical trial processes,   January 31, 2024
  US FDA guidance says volunteers for clinical evaluation should be free from abnormalities,   January 03, 2024
  Digital Personal Data Protection Act impacts many trial conduct processes,   December 06, 2023
  Clinical trials for medical devices are different from clinical trials of drugs,   November 01, 2023
  There is no regulatory ban against an investigator’s family member participating in a clinical trial,   October 04, 2023
  It is essential for investigator to obtain HMSC clearance,   September 06, 2023
  EC should consider unapproved proposals as new proposals and review thoroughly,   August 02, 2023
  EC should review content of evaluation instruments,   July 04, 2023
  GCP norms recommend sponsor should notify regulatory authority,   May 31, 2023
  EC review should focus on all potential ethical issues,   May 04, 2023
  Sponsor can analyse sample collected prior to withdrawal of consent,   April 05, 2023
  Using 1 central EC for non-interventional study would be non-compliance,   March 01, 2023
  IEC member reviews study without prior knowledge of the study,   February 01, 2023
  Certified copy of original record is a copy that has been verified,   January 04, 2023
  Use of e-mail in place of correspondence is acceptable practice,   November 30, 2022
  EC should advise investigator against recruitment of family member,   November 02, 2022
  EC should review information contained in advertisements and mode of communication,   October 05, 2022
  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

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