Amendments to Protocol / Communications Protocol
INSTRUCTIONS TO APPLICANTS
- Amendments to protocol / Communications will be
submitted to the SRS office in duplicate.
- The change Amendments to
protocol / Communications must be referenced to the IEC no of the
- 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 submitted Communications or
- Acknowledgement of the submission must be obtained
immediately from the SRS office.
- The amendment to the Protocol or
the Communication will be put up to the IEC.
- Only after the IEC
approves the communication / amendment to the protocol changes can be made to