Table 6: Recent Initiatives by CDSCO for Promoting Ethical Clinical Research

  • Review of proposal- Time lines
  • Phase 0, Phase-1 and Micro dosing trial- initiatives
  • Guidance on Clinical Trial Inspection-November 2010
  • Rule 122 DAB : Registration of CROs for conducting clinical trials- Jan 2011
  • Draft guidelines for reporting Serious Adverse Event- May 2011