Harold and Muriel Block Institute for Clinical and Translational Research at Einstein and Montefiore

Confidential Disclosures, Clinical Trial Agreements and Contracting

Confidential Disclosure Agreements (CDA)

What is a Confidential Disclosure Agreement (CDA)?
A CDA is a legal document that ensures confidentiality of proprietary information that a sponsor gives to the principle investigator. A signed, study specific CDA may be required before a sponsor will provide its proprietary information, such as the study protocol, to an Investigator.

Involved Parties of a CDA:
The Office of Clinical Trials will sign the CDA on behalf of Montefiore and Einstein College of Medicine after appropriate legal review.

Terms of the CDA:
The terms and conditions of a CDA are negotiated in accordance with Montefiore and Einstein policy.

  • OCT will negotiate with Sponsor until agreement is acceptable to both parties.
  • OCT’s review of the CDA is important since the terms negotiated in this agreement may be incorporated into the provisions for the study specific Clinical Trial Agreement.

Clinical Trial Agreements (CTA)

Clinical trial agreements are the true legally binding contract for services agreed to by the sponsor and institution. They define specifically what will be done, to whom and when, and who will be responsible for costs. They are the final common pathway for all studies, and often negotiating they are the longest step of all the processes.

The Office of Clinical Trials (OCT) will manage, negotiate and finalize contracting. All contracts by necessity include a finalized and mutually agreed upon budget as an amendment to the contract language itself.

Master Clinical Trial Agreements

The Office of Clinical Trials has an expedited track that will improve turnaround time for contract documents. A Master Clinical Trial Agreement is an umbrella agreement between a company and our institution in which both parties agree upon a set of contractual terms and conditions for future clinical trials contemplated by the agreement. This alleviates the need to negotiate contractual terms for individual clinical trials. Instead, each subsequent clinical trial is contracted for based upon an already agreed to series of terms and conditions.

Montefiore, Einstein and BRANY have a constantly changing and expanding list of Master Agreements covering clinical trials with companies; check with our office to see if your proposed sponsor has agreed to a master agreement with us.

Note: Principal Investigators do not have the authority to sign contracts on behalf of the Institution. 

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