You can find the complete set of relevant documentation and forms available for download here
OR You can download the individual documents and forms here:
- PIEC Application Form
- Form Annex A - Placebo Usage
- Form Annex B - Conflict of Interests Declaration
- Form Annex C - Biological Materials Storage
- Form Annex D - Industry Sponsored Studies
- Form Annex E - Waiver of Informed Consent
- Form Annex F - Research involving Pregnant Women, Foetuses and Neonates
- Form Annex G - Research involving Children
- PIEC Project Status Report Form
- PIEC Protocol Amendment Cover Note
- PIEC Application Form (Exempt)
- PIEC UPIRTSO Report Form
- Form Annex A - Multiple Studies Reporting
- PIEC Protocol Deviation Report
Any queries you have may be directed to piec@gleneaglescrc.com
The Parkway Independent Ethics Committee is the only independent ethics committee in Singapore, formed to govern the conduct of the clinical research studies in the
ParkwayHealth group of Hospitals, and can also review clinical trials for Private General Practitioners and Private Medical Institutions that do not have an in-house Ethics
Committee.
The PIEC is an ICH-GCP compliant independent ethics committee constituted of medical / scientific professionals and non-medical / non-scientific members, whose
responsibility is to ensure the protection of the rights, safety and wellbeing of human subjects involved in trials.
To this end, the Parkway Independent Ethics Committee reviews and approves / provides favorable opinion on the trial protocol, the suitability of the investigator(s),
facilities and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
The Committee meets as necessary, and the submission deadline is the last working day of the month.
Submissions to the PIEC must include the
- PIEC Application Form for Research Involving Humans (IEC-SOP-F-01),
- Protocol,
- Informed Consent Form,
- Subject Information Statement,
- Subject recruitment procedures such as advertisement and
- other documents as specified in the application form
- If the translated informed consent form is available, this should be submitted together with the supporting translation certificates to PIEC for acknowledgement, otherwise at a later date when ready.
- The submission should be accompanied by a cover letter printed on appropriate institutional letterhead from the principal investigator. Written correspondences with the PIEC should be done by the principal investigator, and not through the Sponsor.
For full review, 1 original, 14 copies and 1 soft copy of the clinical research proposal need to be submitted to PIEC.
For expedited review, one (1) original copy will suffice. Studies are eligible for review through the expedited review procedure if the proposed study involves no more than minimal risk to human subjects.
Important:
(1) Always download the Forms from our website to ensure that you are using the latest version.
(2) Please do not bind your Application Forms. Please submit them in either 3inch Arch Files or ‘A4 Clear view folders’.
(3) Please note that the PIEC will be unable to release the Approval Letters if payment has not been received.
| PIEC Fee Structure (Excluding GST) | |
| Categories | SGD |
| Industry Sponsored_Phase I | |
| Initial Application (Full-Board Review) | 3000 |
| Continuing Review (Full-Board Review) | 2000 |
| Protocol Amendments (Full-Board Review) | 500 |
| Industry Sponsored_Phase II-IV | |
| Initial Application (Full-Board Review) | 2700 |
| Continuing Review (Full-Board Review) | 2000 |
| Protocol Amendments (Full-Board Review) | 500 |
| Initial Application (Expedited Review) | 1000 |
| Continuing Review (Expedited Review) | 700 |
| Protocol Amendments (Expedited Review) | 300 |
| PI-Initiated_Phase II-IV | |
| Initial Application (Full-Board Review) | 1200 |
| Continuing Review (Full-Board Review) | 1000 |
| Protocol Amendments (Full-Board Review) | 500 |
| Initial Application (Expedited Review) | 600 |
| Continuing Review (Expedited Review) | 600 |
| Protocol Amendments (Expedited Review) | 300 |
| Cellular Therapy | |
| Initial Application (Full-Board Review) | 3000 |
| Continuing Review (Full-Board Review) | 2000 |
| Protocol Amendments (Full-Board Review) | 500 |
| With Effect from 01 July 2008 | |