cess. To streamline the lengthy negotiation process, the IOM Drug Forum commissioned the development of templates for both CTAs and material transfer agreements (MTAs).5 The templates, which are intended for widespread use, incorporate language considered acceptable to key stakeholders. Where companies and universities tend to have significant differences, the templates annotated the standard language to highlight and provide context for those differing positions. Alving described CTSA program efforts to disseminate the CTA and MTA templates to the CTSA consortium and to educate academic health centers on how they can be used effectively. The National Cancer Institute (NCI) also has created template agreements to facilitate contract negotiations. The NCI templates—Standard Terms of Agreement for Research Trial (START) Clauses—are based on the results of a survey of all NCI cancer centers.

Alving also described the following programs supporting CTSA institutions and other clinical research programs:

  • Research Electronic Data Capture (RedCap)6 gives research teams an easy way to collect, disseminate, and protect the privacy of study data. It comprises two secure Web-based applications and provides software and support to partners (CTSA institutions, General Clinical Research Centers, Research Centers in Minority Institutions, and other institutions) at no charge in exchange for participation in the consortium. Alving reported that 3,000 researchers currently use RedCap across 56 institutions and 22 countries.

  • CTSApedia7 will be a comprehensive online resource for those seeking courses in clinical and translational research. This resource will be available to both CTSA and non-CTSA institutions.

  • Researchmatch.org, launched in October 2009, is a Web-based patient recruitment registry connecting willing clinical trial volunteers with researchers. It currently supports the CTSA consortium of institutions.8

5

The CTA and MTA templates can be found at http://iom.edu/~/media/Files/Activity%20Files/Research/DrugForum/April27-28/TemplateCTA%2042209.ashx and http://iom.edu/~/media/Files/Activity%20Files/Research/DrugForum/April27-28/TemplateMTA%2042209.ashx.

6

Additional information on RedCap can be found at http://www.project-redcap.org/.

7

Additional information on CTSApedia can be found at http://www.ctspedia.org/do/view/CTSpedia/WebHome.

8

Additional information on the Research Match Network can be found at https://www.researchmatch.org/partners/.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement