The CTA is required when a material is being brought into NINDS specifically with human research as an ultimate goal of the research. Preclinical work is often part of the CTA, but the end research goal of any CTA is human research. Many look upon the CTA as a “human research MTA” but it is in fact much more expansive and defining. Like the MTA, however, the CTA cannot promise intellectual property rights to the “partner” nor can it be utilized for materials that are commercially available.

The primary components of a CTA are:

• Clarification of provider and recipients roles in the research
• Development, design, and approval of the clinical trial protocol
• IND ownership and FDA governed responsibilities
• Data ownership and exchange
• Publication rights and responsibilities
• Termination and assurance of patient rights