The JCTO drafts, reviews and negotiates several types of clinical research agreements. This section describes the different types of agreements as well as the documents and information required to initiate and complete this process.
Confidential Disclosure Agreement (CDA)
A CDA is a contract governing the obligations of the parties who receive and/or disclose confidential information. For example, an industry sponsor may wish to disclose a study protocol to a PI for a feasibility review but the protocol may include confidential information that must be safeguarded. The types of CDAs are described below:
A Sponsor-initiated CDA is required prior to a sponsor releasing confidential information, such as a protocol, to a PI. The terms of the CDA govern the PI’s obligations of confidentiality with respect to the information disclosed. The CDA also protects WCMC/NYP when it is a party to the agreement.
Mutual Disclosure CDA
A Mutual Disclosure CDA is entered into when an industry sponsor or academic institution and WCMC/NYP exchange confidential information to determine whether one party wants the other party to participate in the conduct of a clinical trial. A PI may disclose a protocol he or she designed to an industry sponsor to see whether it will provide a drug or device for the study. An industry sponsor may want advice from a PI regarding the design or conduct of a trial.
An Investigator-initiated CDA is entered into when a PI discloses confidential information to industry or an academic institution.
To initiate the review of a CDA email the following documents to JCTOcontracts@med.cornell.edu.
- PI’s office mailing address
- Indicate whether the PI is receiving and/or providing confidential information
- Word version of the draft CDA (if available)
Clinical Trial Agreement (CTA)
A CTA is an agreement governing the terms and obligations of all parties during the conduct of a clinical trial. A CTA must be fully executed prior to study activation. WCMC, NYP and the sponsor are all parties to a CTA. The PI’s signature indicates his or her understanding of the terms. The types of CTAs are described below.
CTA with an Industry Sponsor
A CTA with industry can be sponsor or investigator initiated. A sponsor initiated CTA is required when WCMC/NYP participates in an industry-sponsored clinical trial, where the study drug or study device and/or funding are provided. An investigator initiated CTA is required when an industry sponsor is supplying a study drug or study device and or/funding for an investigator initiated trial.
CTA with an Academic Institution
A CTA with an academic institution is usually either a sub-award or subcontract. A sub-award agreement or a subcontract is a contract in which a lead site recruits a sub-site(s) to conduct a clinical trial. WCMC/NYP can serve as the lead site or a sub site.
To initiate review of a CTA email the following documents to JCTOcontracts@med.cornell.edu.
- Clinical Trials Synopsis Form (CTSF)
- Study protocol
- Informed Consent Form (draft or sponsor template is sufficient if not approved)
- Word version of the CTA template
Throughout the life of a CTA or other agreement, the budget, protocol or terms of the contract may be amended. When an amendment is received, the details of the amendment should be emailed to JCTOcontracts@med.cornell.edu for review and negotiation of its terms.
Data Use Agreement (DUA)
A DUA is a contract that governs the transfer of data outside the context of a CTA or Sponsored Research Agreement (SRA). When WCMC/NYP enters into a DUA, it shares, receives or transfers de-identified data, limited data sets or fully identifiable data.
To initiate review of a DUA email the following documents to JCTOcontracts@med.cornell.edu.
- DUA Routing Form
- Word version of the DUA template (if available)
- Protocol or description of the data being received, shared or transferred
Service Agreement (SA)
A Service Agreement is a contract used when WCMC/NYP or a PI is hired to perform a service that is not covered by a CTA or SRA. The following is an example of an arrangement that would be negotiated as an SA: an industry sponsor hires WCMC's Imaging Data Evaluation and Analytics Laboratory (IDEAL) staff to measure the diameter of certain heart valves on x-rays.
To initiate review of an SA email the following documents to JCTOcontracts@med.cornell.edu.
- Word version of the Service Agreement template (if available)
- Protocol or description of the services being performed
Registry Agreement (RA) and Subcontracts
A Registry Agreement is a contract governing situations in which patients are required to provide informed consent to have their health information recorded in a registry database.
To initiate review of an RA email the following documents to JCTOcontracts@med.cornell.edu.
- Clinical Trials Synopsis Form
- Study protocol
- Informed Consent Form (ICF) (a draft is sufficient)
- Word version of the RA template
Master Clinical Trial Agreements (MCTA)
WCMC/NYP frequently works with industry sponsors or academic institutions on multiple clinical trials. In these cases, a MCTA can be negotiated containing global contract terms. An MCTA allows the contracts specialist to negotiate a work order for the specific study. Below is a list of all active MCTAs.
- Abbott Cardiovascular Systems, Inc.
- AbbVie Inc.
- Alexion Pharmaceuticals
- Aplastic Anemia & MDS International Foundation
- Astellas Pharma Global Development (APGD)
- Biogen MA Inc.
- Biotronik Inc
- Boehringer Ingelheim Pharmaceuticals Inc (BIPI)
- Bone Marrow Transplant Network (BMTN)
- Bristol-Myers Squibb Company
- Celgene Corporation
- Cochlear Americas
- Cook Incorporated
- Genentech Inc.
- Gilead Sciences Inc.
- Immunomedics Inc
- InSightec-Image Guided Treatment Ltd
- Janssen Research and Development LLC
- MacroGenics, Inc.
- Medtronic, Inc.
- Merck Sharp & Dohme Corp.
- Millennium Pharmaceuticals
- Novartis Pharmaceuticals Corporation
- Novo Nordisk Inc.
- Onyx Pharmaceuticals
- Purdue Pharma LP
- Qi Imaging LLC
- Regeneron Pharmaceuticals Inc.
- Sanofi US Services Inc.
- Seattle Genetics Inc.
- Sideris Pharmaceuticals
- Sucampo Pharma Americas LLC
- Sunesis Pharmaceuticals Inc.
- UCB Biosciences
- Intercept Pharmaceuticals
- SC Liver Research Consortium