The Ophthalmology CRU will coordinate the review and approval process of agreements (new and amendments) with the Office of Corporate Research and Collaboration (OCRC)*.
Agreements include:
- Clinical Trial Agreements (CTA)
- Confidentiality and Nondisclosure Agreements (CDA)
- Data Transfer Agreements (DTA)
- Data Use Agreements (DUA)
- Material Transfer Agreements (MTA)
- Sponsored Research Agreements (SRA)
- All agreements (new and amendments), in Word, along with sponsor contact information, to Sarah K Jones, MS, CCRC
- All agreements (new and amendments) will be reviewed and approved by OCRC BEFORE the PI signs the document.
- A representative from Duke’s Office of Clinical Research (DOCR) will sign agreements (new and amendments) on behalf of the institution (i.e., Duke University). NOTE: An agreement is not executed (“official”) until ALL parties have signed the document and Duke receives and recognizes the fully executed agreement.
- Ophthalmology’s CRU will maintain an executed copy of the agreements and can send copies of original agreements (new and amendments) to the study team for the study regulatory binder.
The Office of Corporate Research and Collaboration (OCRC) has responsibility for research-related interactions with commercial entities including clinical trials, non-clinical sponsored research, material transfers, and other related endeavors. OCRC also has intellectual property management responsibilities, particularly those arising from, or closely associated with, commercially sponsored research projects.