Regulatory obligations of a sponsor
The responsibilities of the sponsor are as follows:
- Obtain Clinical Trial Authorisation (CTA), or acceptance of Clinical Trial Notification (CTN), of the clinical trial
- Obtain approval for, or acceptance of notification of, substantial amendments to the clinical trial
- Notify us of trial status, suspension, termination and conclusion, and submit final report within stipulated timelines
- Ensure information in the Investigator’s Brochure (IB) is concise, objective and kept up to date
- Ensure that the clinical trial is conducted under supervision of qualified PI
- Ensure that the clinical trial is conducted at specified locations
- Carry out functions of the sponsor in accordance with principles of Good Clinical Practice (GCP)
- Put and keep in place arrangements to ensure compliance with principles of GCP
- Notify us of serious breaches and urgent safety measures taken to protect subjects against immediate hazard within stipulated timelines
- Keep adequate essential documents
- Ensure appropriate investigational and auxiliary product labelling
- Report unexpected serious adverse drug reactions and medical devices adverse reactions within the stipulated timelines
Note: Even though the sponsor may delegate or outsource any of the above responsibilities to another company, the sponsor is still ultimately responsible for the conduct of the clinical trial.
Additional sponsor responsibilities for multi-sponsor investigator-initiated trials
For multi-sponsor investigator-initiated trials, where a clinical trial on a single protocol is conducted at more than one local trial site, the lead sponsor and participating site sponsor have additional responsibilities beyond the sponsor responsibilities mentioned above.
The lead sponsor must ensure the following:
- Regulatory submissions and notifications to us (e.g. CTA/CTN/CTC applications, amendments, serious breaches, trial status reports, final reports, etc)
- Ongoing safety evaluation of study drugs administered to subject
- Prompt notification to all participating site investigators/institutions of findings that could adversely affect subject safety or impact conduct of trial
- Notification of unexpected serious adverse drug reactions, and serious breaches to us
The participating site sponsor must ensure the following:
- Report immediately to lead sponsor any Serious Adverse Event (SAE) at the participating site, or any finding that could adversely affect subject safety or impact conduct of trial
- Provide all relevant information to lead sponsor that is necessary for the lead sponsor to perform trial-related regulatory submissions and notifications to us
Refer to our Guidance on Multi-sponsor Investigator-initiated Trials360 KB for more details.
Transfer of local sponsorship for ongoing clinical trial
For transfer of local sponsorship for an ongoing clinical trial to another locally registered company, the new local sponsor should submit a new clinical trial application to us.
The new clinical trial application must contain the following:
- All currently-approved study documents as required for a new clinical trial application
- Letter from the current local sponsor indicating transfer of local sponsorship to the new local sponsor. This letter should be copied to the new local sponsor and the respective trial site PI and IRB
Upon receipt of the clinical trial authorisation (CTA), acceptance of notification (CTN) or approval of (CTC) the clinical trial, the current local sponsor should submit a Trial Status Report to indicate the change of local sponsor. This can be done by indicating the trial status as “premature site closure” and providing the reason as change of local sponsor.
Change in contact person
The contact person of the local sponsor is the applicant who had submitted the most recent PRISM application for that clinical trial (excluding safety reports). It is essential to inform us of a change in the contact person, as e-mail reminders for the submission of Trial Status Report are sent to this individual.
The change of local sponsor contact person may be made through the submission of a Trial Status Report or any other application (excluding safety reports). Subsequent regulatory correspondences would thereafter be directed to the new local sponsor contact person after the submission has been processed by us.
Change in company address
The local sponsor may update the new company dress through the Amend Company Information module via PRISM, and should inform us via our online feedback form.