Table 2.
Agreements developed by the CTSA/Trial Innovation Network as part of the accelerated research agreements initiative
| Template Name | Function | Level of adoption | Last revision date |
|---|---|---|---|
| Accelerated Confidential Disclosure Agreement (ACDA) | Support sharing of protocols across participating sites in a multicenter trial | > 80 research sites (e.g., academic medical centers, universities, hospitals, industry sponsors) have registered | February 2016 |
| Contract Research Organization ACDA (CRO-ACDA) | ACDA adapted for use with Contract Research Organizations (CROs). | Registration not tracked | February 2016 |
| Federal Demonstration Partnership Clinical Trials Subaward Agreement (FDP-CTSA) | Sub-award template for federally funded clinical trials. | 12 research sites (e.g., academic medical centers, universities, hospitals, industry sponsors) have registered | July 2016 |
| Contract Research Organization ACTA (CRO-ACTA) | ACTA adapted for use with Contract Research Organizations (CROs). | Registration not tracked | October 2016 |
| Data Transfer and Use Agreement (CTSA-DTUA) | Developed to facilitate transfer and use of data between sites. | Registration not tracked | August 2017 |
| Investigator-Initiated ACTA (II-ACTA) | Agreement for use in studies initiated, designed, developed and managed by the sponsor. | Registration not tracked | August 2017 |
| Trial Innovation Network Confidential Disclosure Agreement (CDA) | Sharing TIN protocols, such that investigators and/or their designees can determine whether their site would be interested in participating in a Network Study. | >60 CTSA sites and 21 affiliates have executed | October 2017 |
| Non-interventional Trial Innovation Network FDP-CTSA Standard Agreement | Derived from the TIN FDP-CTSA Standard Agreement, for use with all research that is observational or does not involve an investigational drug or device but may involve, but is not limited to PHI, clinical testing or procedures, or any planning/lab/clinical service in support of such clinical research. | Sites not required to register for this template, derived from the previously agreed upon terms in the FDP-CTSA Trial Innovation Network Standard Agreement and represents an atypical use case | January 2018 |
| VA-specific Trial Innovation Network Confidential Disclosure Agreement (CDA) | Adapted for VA sites interested in sharing TIN protocols, such that investigators and/or their designees can determine whether their site would be interested in participating in a Network Study. | Sites not required to executes as it is VA-specific and used as a “one off” agreement | January 2018 |
| Accelerated Clinical Trial Agreement (ACTA) | Agreement for use in industry-sponsored multicenter study. | > 350 research sites (e.g., academic medical centers, universities, hospitals, industry sponsors) have registered | December 2019 |
| International ACTA (iACTA) | Agreement for use in industry-sponsored multicenter studies involving international sites. | Registration not tracked | December 2019 |
| Trial Innovation Network FDP-CTSA Standard Agreement | Agreement developed for TIN multicenter federally funded clinical trial sub-awards. | >60 CTSA sites and 10 affiliates have registered | April 2020 |