Master Clinical Trial Agreement
Clinical trial start-up time is one of the key considerations when performing site selection for clinical trials. It includes time taken for clinical trial agreement negotiations, IRB approval, regulatory approval and site startup. The time taken for negotiating the clinical trial agreements can go up to six (6) months.
To address the slow contracting time due to legal issues, cost negotiations and response time, NCO has developed a master clinical trial agreement (MCTA) template for sponsored trials together with the Singapore Association for Pharmaceutical Industries (SAPI) and the three (3) public sector healthcare clusters (Singapore Health Services, National Health Group and National University Health System) to shorten contract review time. The terms and conditions in the MCTA template have been pre-negotiated between SAPI and the three (3) public sector healthcare clusters.
Who should be using the MCTA?
Sponsors interested in conducting clinical trials with public institutions across healthcare clusters will find the MCTA to be very useful as it contains pre-negotiated terms and conditions agreed by the healthcare clusters. The MCTA is also useful as a guide for biotechs and new start-ups.
How to use the MCTA?
The MCTA is a live document that can be downloaded in editable form. Users can use the MCTA as is or can adopt the individual clauses into existing agreements. If users are using the MCTA as is, additional requirements to the study can be added to the SCHEDULE, which can be found at the end of the MCTA document.
What should you do if you have any feedback?
If you have any questions or if you would like to provide feedback about the MCTA, please email contact@scri.cris.sg. Our team will be on hand to address any queries.