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