Launching human studies in multiple institutions is complicated and can sometimes take many months. There are many contributors to these time delays, but a prime cause is the review and negotiation process for various agreements associated with research activities. For each new study that a researcher or sponsor proposes, several agreements may need to be reviewed, e.g., a confidential disclosure agreement, a clinical trial agreement, a data use agreement, a material transfer agreement. The Accelerated Research Agreements Initiative provides agreements that are acceptable to participating institutions and organizations; when used, these will expedite the study initiation process.
With the use of the Accelerated Confidential Disclosure Agreement template, protocols can be obtained by participating sites without confidentiality agreement negotiation delays, placing those sites at an advantage to initiating trials earlier than current processes permit.
Institutions and Industries can use the Accelerated Clinical Trial Agreement for sponsor-initiated multi-site trials. This streamlined process will allow sites to participate in clinical trials earlier in the process without undue delays in contract negotiations.
The CTSA-DTUA (Clinical and Translational Science Award – Data Transfer and Use Agreement) was developed to help facilitate a more streamlined process for transfer and use of data between sites.
A sub-award template for federally funded clinical trials negating the need for tedious negotiations. Approved for use by the CTSA stakeholders, the NIH, and the FDP.