Any study which involves a systemic investigation designed to develop or contribute to generalizable knowledge is considered a research. If a research study involving human subjects is conducted in ParkwayHealth group of Hospitals, Private General Practitioners or Private Medical Institutions that do not have an in-house Ethics Committee, an ethics approval is required from PIEC before the research study is initiated.
DHHS Guidelines (45 CFR Part 46.101 (b)) define the type of research that can be exempted from IRB review. The research study should involve no risk to the subject. Examples are survey or interview research in which subject will be anonymous (subject cannot be identified, directly or indirectly through identifiers linked to the subject). The study still has to be submitted to PIEC for screening for exempt status. Please use the PIEC Application Form (Exempt) for submission.
Yes. The exemption from PIEC review is only applicable to the current protocol. Any proposed change to the exempted study has to be reviewed by PIEC before implementation. Please submit the PIEC Protocol Amendment Note together with a tracked changes and clean copy of the document.
A new study submission can be subjected to expedited or full-board review by assessing the level of potential risk to subjects involved. To qualify for an expedited review, the PIEC reviewer must determine that a research proposal presents no more than minimal risk to research subjects. A study that involves greater than minimal risk requires a full-board review. Both expedited and full-board review will require submission of the PIEC Application Form and all necessary documents. The final determination of the review type will be made by the PIEC upon receipt of the submission dossier.
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 CV (signed and dated) and a GCP or CITI certificate.
SGGCP Guidelines (Section 6) presents 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 at email@example.com for guidance on drafting the ICF.
The Investigator’s Brochure (IB) is a compilation of the clinical and non-clinical data on the investigation product(s) that are relevant to the study of the product(s) in human subjects. The IB must be submitted if the research study involves investigation product(s) in human subjects. Its purpose is to provide information of the investigation product to the investigator and others involved in the trial. If a marketed product is being studied for a new indication, an IB to that new indication has to be prepared. Article 7.2 and 7.3 of the SGGCP delineates the minimum information that should be in included in an IB.
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.
Minor amendment and administrative amendment to the Protocol or ICF is subjected to expedited review. Major amendment to the Protocol or Informed Consent Form that increase the overall risk benefit ratio is subjected to a full-board review. Please submit the PIEC Protocol Amendment Note together with a tracked changes and clean copy of the document.
UPIRTSO stands for Unanticipated Problems that May Involve Risks to Subjects or Others. It refers to problems, in general, to include any incident, experience or outcome which in the opinion of the local investigator was unexpected, at least possibly related to the research procedures and suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized.
If a local death is involved, whether related or not, it should be reported to PIEC immediately, within 24 hours after first knowledge by study investigator. All other UPIRTSO should be reported as soon as possible but not later than 7 calendar days after first knowledge by study investigator. Please complete and submit the PIEC UPIRTSO Report Form together with the CIOMS/MedWatch form.
If the overseas adverse event is unexpected and related to the study procedures (e.g. study drug), you should report to the PIEC using the PIEC UPIRTSO Report Form together with the CIOMS/MedWatch form.
Please complete the PIEC Project Status Report Form and submit to PIEC. For completed study, please also submit the Clinical Study Report once available to PIEC for reference.
The full-board review of complete submissions should usually take up to 30 days from the monthly deadline. For expedited review, the process usually takes between 2-4 weeks upon receipt of your applications.
If a research proposal is approved as submitted with no change required to any document, the Principal Investigator will receive an approval letter from PIEC. If there are queries pertaining to the study, the Principal Investigator will receive an email requesting for clarification or information by the PIEC coordinator. If the Principal Investigator 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 Principal Investigator will receive a non-approval letter with the reasons for the decision.
Please kindly make the cheques payable to “Gleneagles CRC Pte Ltd” and submit the cheque together with your applications.
Please refer to the PIEC Fee Structure on the PIEC website. The review fee is the price stated plus the prevailing GST. Please note that the PIEC will be unable to release the approval letter if payment has not been received.
The mailing address is Parkway Independent Ethics Committee, c/o Gleneagles CRC Pte Ltd, ParkwayHealth Day Surgery and Medical Centre, 363 Balestier Road, Level 4, Singapore 329784.
Any queries can be directed to PIEC secretariat via email at firstname.lastname@example.org or phone at 6737 3642.
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