Master Clinical Trial Agreement

When researchers often collaborate with a particular sponsor of the OUHSC, the ORA often suggests that the industry sponsor use previously negotiated clinical trial agreements as „models“ for future studies. When an industry sponsor agrees to use „models,“ both parties always have the option of renegotiating each language that requires revision because of the diversity of study, change or business guidelines, etc. In many cases, the need to renegotiate conditions is quite low, resulting in a much shorter period of time for the conclusion of the clinical trial agreement. Each sponsor in the industry is unique and, ultimately, each sponsor decides whether or not to allow the use of master-templates. The use of Master Clinical Trial Agreements is an important tool to start studies as quickly and easily as possible. We now have MCTAs with more than 40 commercial sponsors, and the ARU is constantly working on revisions, renewals and/or new agreements. The team of authors recognized differences between national and local laws, as well as organisational guidelines, by setting the minimum threshold of 90% for the accepted MCTA EFS. In order to ensure additional efficiency for the remaining 10% (or less) of the MCTA negotiations of the sponsor and the institution of the EFS, The team of authors recommends focusing legal resources on the following MCTA sections and/or addressing specific test points in a corresponding working statement (SOW): 1st Section 11.5: Record Retention Master Clinical Trial Agreements (MCTA) provides agreed conditions for the basic relationship between the university and a sponsor. Once an MCTA is in place, a supplement or study letter is usually generated for each new study to be conducted under the MCTA. The addendum lists the points that are, in particular, for a specific study, such as. B budget and payment conditions, calendar details, protocol name and senior controller.

These Addenda are attached to the MCTA. This reduces the need to negotiate the main terms of the agreement, since most of the terms have been agreed and only details need to be negotiated. The use of Master Template Agreement can significantly expedite the conclusion of contract negotiations for a clinical trial. Master`s agreements generally require intensive negotiations, as their conditions must be acceptable for all clinical trials submitted to them. A master`s contract can take years to negotiate and conclude, but it is generally valid three (3) to five (5) years after signing. It is very difficult to change the terms of a master`s contract after being executed by all parties.