Center for Research Excellence (PU-CRE)

Application and Report Submission

All investigators must obtain PU-IRB approval BEFORE commencing with any studies. Research guidelines can be found here. Researchers are responsible for ensuring that all forms are filled completely and accurately, and all applications and reports are submitted in a timely manner. Please contact PU-RMC Manager, Dr. Sathiya Maran ([email protected]) if you require assistance or clarification with the forms and approval procedure.

1. New Study Application

For any study that is being considered for initial review and approval.

1. Application for Initial Review (PU-211)
2. Consent Document (PU-502)
3. Investigator Protocol (PU-503)
4. Request for Determination that Research Does NOT Involve Human Subjects (PU-574)
5. Request for Exemption from Continuous Review (for Research Involving Human Subjects) (PU-575)
6. Application Form for IRB Approval of Research Projects Involving Animals (PU-701)
7. Application Form for Scientific Merit Review – Animal Research (PU-702)
8. Attending Veterinarian (AV) Approval Form – Animal Research (Appendix A)

2. Modifications to Secure Approval

Made when PU-IRB has responded requesting for a modification to the research before approval can be finalised.

• Modifications Required to Secure Approval of Human Research (PU-215)

3. Amendment Application

This is to request for approval of any changes to the currently approved protocol. These are only considered after a study has received an initial review and approval as a new study.

• Modification of Approved Research (PU-213)

4. Continuing Review Application

This is also referred to as “Renewal” of approved protocol. Applicants are requested to submit a completed form within 30 days of study closure for the approval. Failure to do so will cause the protocol approval to expire.

• Continuing Review Progress Report (PU-212)

5. Study Closure Report

This is submitted when the investigator would like to close the study.

• Continuing Review Progress Report (PU-212)

Note: Applications for PU-IRB approval shall be submitted through the Perdana University-Research Management Centre (PU-RMC). Applicants are requested to submit one (1) original copy to the Manager of PU-RMC and one (1) electronic copy via [email protected].

Committee Members

Human Subject Research Training

The Perdana University investigators and staffs who conduct human subject research must complete the following training initiatives before submitting an application to PU-IRB:

National Institutes of Health (NIH) Protecting Human Research Participants (PHRP) Training

The NIH-PHRP training consists of four sections, a quiz will be given at the end of each sections. Prior to submission of the quiz, a score will be given. Once the quiz has been completed with a satisfactory score, a check mark will appear next to the score on the main page. If the obtained score is lower than the required benchmark score, then the section should be reviewed and the quiz should be retaken until a satisfactory score has been attained.

Once the training has been successfully completed, a link will appear on the main menu allowing access to your “Certificate of Completion”. This certificate should be printed and submitted to the Manager of PU-RMC, as a prove of completion of the training.

PU-IRB Meeting Dates

The closing date for submission of ethical review application is the first day of each month, or the next working day if the first day falls on a Saturday, Sunday or a public holiday. If submitted by this date, researchers can expect a response within 1 month unless full committee reviews required. Full committee review is required for: research involving vulnerable populations such as prisoners, children, decisionally impaired individuals, pregnant women, foetuses, and neonates, all medical education research involving students, and all animal research. If full committee review is required, please submit the application no less than 3 weeks before the meeting date. However, the earlier the better as if there are multiple applications the PU-IRB may need to review them over 2 meetings.