IEC review procedure
The IEC Secretary will schedule complete applications for an IEC meeting. Study documents will be circulated to IEC members before the scheduled meeting.
IEC members present at the meeting will decide on an individual study, and a decision will be communicated to the investigator. The decision may be:
- Study is approved or rejected
- Revision to the study outline may be required
- Additional or amended study documents are needed
In the event of a request for additional or amended documentation, updated study documents must be submitted by the investigator.
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/favorable 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.
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
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 7 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.