Clinical Research Review

How to submit protocol amendments?

• During the trial, the investigator should provide to the IEC all documents that are subject to review. These include amendments made to the study protocol, patient information sheet, informed consent, advertisements, investigator’s brochure, etc.
• No deviations from, or changes of, the protocol should be initiated without prior written IEC approval/favourable opinion on an appropriate amendment, except where necessary to eliminate immediate hazards to the subjects or when the change(s) involve only logistical or administrative aspects of the trial, e.g., change of monitor(s), telephone number(s), etc.
  Download Protocol Amendment Form ( FORM - Protocol Amendment Application Form 2023 01)

For clinical trials, the investigator should promptly report the following changes to the IEC:

• Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects
• Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial
• New information that may affect adversely the safety of the subjects or the conduct of the trial
• All adverse drug reactions (ADRs) that are both serious and unexpected affecting the subject
  Download Protocol Deviation Reporting Form 

Serious Adverse Event (SAE)/Serious Unexpected Adverse Event Reaction (SUSAR) reporting

In the occurrence of a serious adverse event, or serious unexpected adverse event reaction, the following processes must be strictly adhered to.

SAE/SUSAR -fatal/life threatening:

Initial report should be submitted as soon as possible, but no later than seven calendar days from awareness of the event by the investigator, followed by a complete report within 8 additional calendar days.

All other SUSARs/SAEs – non-fatal or non-life-threatening:

No later than 15 calendar days from awareness of event by the investigator. For more detailed information, please contact the IEC Secretariat.

Download Serious Adverse Events Reporting Form ( FORM - IEC RSDHC Serious Adverse Event (SAE) report 2023 01) 

IEC Submission Timelines

IEC Submission Type	Timeline
New applications	IEC will review a new application and give its decision within 60 working days from date of receipt of a valid and complete application
Resubmission of modifications	To be submitted within 60 days of IEC decision letter
Amendments application	For amendments which meet expedited criteria, IEC shall give an opinion within a maximum of 30 days of the date of receipt of the valid and complete proposed amendment submitted. For amendments affecting significantly, it will be tabled at the next scheduled IEC meeting
Disapproved applications	Timeline for appeal submission is within 40 days of the disapproval letter.
SAE/SUSAR -fatal/life threatening	Initial report should be submitted as soon as possible, but no later than seven calendar days from awareness of the event by the investigator, followed by a complete report within 8 additional calendar days.
All other SUSARs/SAEs – non-fatal or non-life-threatening:	No later than 15 calendar days from awareness of event by the investigator. For more detailed information, please contact the IEC Secretariat.
Annual Progress Report	To be submitted at least 30 days before expiry
Research Study Closure Report	To be submitted within 90 days after study completion/closure/termination