Clinical Research Review
Ramsay Sime Darby Health Care’s mission is to promote the very best clinical research. As such our Independent Ethics Committee assesses each application individually and on its own merits. We aim to work closely with study applicants through the entire application process.
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/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.
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