Submission Letter for Serious Adverse Effects for Research Project
- Ethics Committee
- Introduction
- Notification
- Instructions for Research Project Submission Document Application
- Sample Project
- Amendments to Protocol / Communications Protocol
- Principal Investigator Change Protocol
- Application Letter for Release of Finances
- Submission Letter for Deposits towards Project
- Submission Letter for Serious Adverse Effects for Research Project
- Research Project & Amendments Processing Fees
- Research Project Document Submission Check List Format
- Acknowledgement Form Format
- Title Page Format
- Joint Undertaking by Principal Investigator and Sponsor Format
- Project Index page Format
- Covering Letter Format
- Project Summary Format
- Research Protocol Application Format
- Project Completion Letter Format
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