Amendments to Protocol / Communications Protocol


  • 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 project.
  • 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 Amendments
  • 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 the project.