Submission Letter for Serious Adverse Effects for Research Project


  • All serious adverse effects related to the project must be informed immediately in writing to the IEC HR.
  • The communication must be made in Triplicate.
  • The assigned IEC No., Sponsor name ( if applicable ), the Abbreviated Trial Name and the Principal Investigator Name shall be incorporated as footnote on each and every page of the Serious Adverse Effects submission  
  • Acknowledgement of the submission must be obtained immediately from the SRS office