The Health Sciences Authority (HSA) issues the regulatory approval, in the form of a Clinical Trial Certificate (CTC) to the clinical investigator. The CTC is issued in the name of the principal investigator. It is specific for each study protocol, and for each institution or site involved in the study.

Each CTC is valid for a period of two years unless otherwise stated.

If a trial is not expected to be completed before expiry of the CTC, the sponsor has to make a written request for an extension of the CTC and submit an interim clinical trial status report to support the request. Such requests should be made 3 months before the CTC expires.

Electronic applications for the extension of CTC can be made online if the initial CTC application was submitted online. Please submit a Clinical Trial Status Report online at prism@hsa. Once the status report has been acknowledged via email, you may proceed to submit the application for extension of CTC at the same link.

For CTC applications that were submitted manually, please download the Clinical Trial Status Report Form.