Submission Letter for Serious Adverse Effects for Research Project
INSTRUCTIONS FOR SUBMISSION
- 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