Frequently Asked Questions
DHHS Guidelines (45 CFR Part 46.101 (b)) define the type of research that can be exempted from IRB review. It is the responsibility of the Principal Investigator (PI) to apply for exemption from the PIEC. Only studies that have official approval from PIEC for exemption will qualify as exempted studies. To apply for an exemption approval, the PI is required to use PIEC Exemption Application Form for submission.
Yes. The exemption from PIEC review is only applicable to the current protocol. Any proposed changes to the exempted study has to be reviewed by PIEC before implementation. Please submit the PIEC Study Amendment Cover Note together with tracked and clean copies of the document.
It means the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Yes. All investigators need to submit their latest CV and a GCP certificate.
SGGCP Guidelines (Section 6) present the topics that should be included in a clinical trial protocol. Please use the SGGCP as a guide in drafting your study protocol.
SGGCP Guidelines (Section 4.8.10) provide a list of elements to be included in the Informed Consent Form (ICF). You may wish to contact us for guidance on drafting the ICF.
It is not mandatory to follow a specific guideline. However, it is recommended for you to adopt the Association of the British Pharmaceutical Industry (ABPI) guidelines, relating to compensation for injury arising in the course of clinical trials.
If a research proposal is approved as submitted with no change required to any document, the Principal Investigator (PI) will receive an approval letter from PIEC. If there are queries pertaining to the study, the PI will receive an email requesting for clarification or information by the PIEC Secretariat. If the PI is unable to provide a response within 6 months, re-submission of PIEC Application Form is required to resume PIEC review. If a study is not approved, the PI will receive a non-approval letter with the reasons for the decision.
For studies requiring full board review, please observe the Submission Deadlines in order not to miss the review meeting scheduled for a particular month. For studies qualifying for expedited review, the application may be submitted to PIEC on any business day.
The full board review of complete submissions should usually take up to 30 days from the submission deadline. For expedited review, the process usually takes between 2-4 weeks upon receipt of your applications.
Yes, as long as there are research activities, including data analysis, the study requires a valid approval to continue.
However for multi-centre studies, the study is deemed “completed‟ when no further data will be collected from the sites, regardless of the status of global study.
- PIEC Application Form
- PIEC Application Form Annex A - Placebo Usage
- PIEC Application Form Annex B - Conflict of Interests Declaration Form
- PIEC Application Form Annex C - Biological Materials Storage
- PIEC Application Form Annex D - Industry Sponsored Studies
- PIEC Application Form Annex E - Waiver of Informed Consent
- PIEC Application Form Annex F - Research Involving Pregnant Women, Fetuses and Neonates
- PIEC Application Form Annex G - Research Involving Minors
- PIEC Application Form Annex H - Indemnity Form
- PIEC Study Status Report Form
- PIEC Study Amendment Cover Note
- PIEC UPIRTSO Report Form (Internal)
- PIEC UPIRTSO Report Form (External)
- PIEC Noncompliance Report Form
- PIEC Application Form (Additional Signature Page for PI)