The sponsor is a company, institution, or organisation that takes responsibility for the initiation, management and/or financing of a clinical trial.
The sponsor should be a locally registered business entity registered with the Accounting and Corporate Regulatory Authority (ACRA) in Singapore.
Regulatory obligations of the local sponsor
The regulatory obligations of the local sponsor are as follows:
- Obtain Clinical Trial Authorisation (CTA), acceptance of Clinical Trial Notification (CTN) or Clinical Trial Certificate (CTC) for the clinical trial
- Obtain approval for, or acceptance of notification of, substantial amendments to the clinical trial
- Ensure that information in the Investigator’s Brochure (IB) is concise, objective and kept up to date
- Ensure that the clinical trial is conducted by or under the supervision of a qualified PI
- Ensure that the clinical trial is conducted at location(s) specified in the clinical trial application
- Carry out functions of the sponsor, and ensures any person to whom the sponsor has delegated to carry out the functions of the sponsor carries out their respective functions, in accordance with the principles of Good Clinical Practice (GCP)
- Put and keep in place arrangements to ensure compliance with the principles of GCP
- Ensure appropriate investigational and auxiliary product labelling
- Keep adequate essential trial documents
- Notify us of the trial status (including the suspension, termination and/or conclusion of the trial) within the stipulated timelines
- Notify us of serious breaches within the stipulated timelines
- Notify us of urgent safety measures taken to protect trial participants against immediate hazard within the stipulated timelines
- Report unexpected serious adverse drug reactions and medical devices adverse events within the stipulated timelines
- Submit final report within the stipulated timelines
Note: The sponsor may delegate or outsource any of the above responsibilities to another company, but any such arrangement does not affect the responsibility of the sponsor.
Additional sponsor responsibilities for multi-sponsor investigator-initiated trials
For multi-sponsor investigator-initiated trials, where the same clinical trial is conducted at more than one local trial site, the lead sponsor and participating site sponsor(s) have additional regulatory obligations in addition to the sponsor regulatory obligations described above.
The additional regulatory obligations of a lead sponsor are as follows:
- Coordinate all regulatory submissions and notifications to us (e.g. CTA/CTN/CTC applications, amendments, serious breaches, unexpected serious adverse drug reactions, trial status reports, final reports, etc)
- Conduct safety evaluation of the investigational drug on an ongoing basis during the trial
- Promptly notify all participating site sponsors and all principal investigators of any information or findings that could adversely affect trial participants’ safety or impact conduct of trial
The additional regulatory obligations of a participating site sponsor are as follows:
- Provide all relevant information to the lead sponsor that is necessary for the lead sponsor to perform trial-related regulatory submissions and notifications to us
- Report immediately to the lead sponsor any serious adverse event (SAE) at the participating site, or any finding that could adversely affect trial participant safety or impact conduct of trial
Refer to our Guidance on Multi-sponsor Investigator-initiated Trials257 KB for more details.
Requirement for regulatory submissions
All regulatory submissions should be done online via PRISM. The sponsor should have the following credentials before accessing the e-service:
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 new clinical trial application from the new local sponsor, 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 address through the Amend Company Information module via PRISM, and should inform us via email to HSA_CT@hsa.gov.sg.