Step 5: Progress report and final report to be submitted to the committee (This applies to internally and externally funded proposals).
Review of amendments to the originally approved protocol.
Amendments made to protocols shall not be implemented until reviewed and approved by the IEC. Expedited review is possible if amendments are for administrative reasons or amendments do not alter the participant rights, safety and wellbeing. In all other situations full Committee review of the amendments shall be done.
Pl has to submit hard copies of the already approved documents and amended documents and soft copy to the Secretariat.