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Confidential Disclosure Agreements (CDA)
What is a Confidential Disclosure Agreement (CDA)?
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
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
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
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.