Confidentiality Disclosure Agreement/Non-Disclosure Agreement
A Confidential Disclosure Agreement (CDA), sometimes called a Non-Disclosure Agreement (NDA), is a legal document that ensures confidentiality or “secrecy “ of proprietary information that one party gives to another party. A signed CDA is usually required before a sponsor will provide its proprietary information, such as the study protocol, to an investigator.
The terms and conditions of a CDA are negotiated in accordance with Northwell Health’s policy. The CTO will negotiate with sponsors until the agreement is acceptable to both parties. The CTO’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.
There are two types of CDAs, one-way (receiving information, or disclosing information) and mutual (both parties are exchanging information).
CDAs are reviewed and negotiated by the Contracts Division of the CTO.
Clinical Trial Agreement
These are negotiated in the contracts division of the clinical trials office. Please email email@example.com for further inquiries.
Clinical Trial Agreements (CTAs), sometimes called Clinical Study Agreements, are the legally binding contract for services agreed to by the Sponsor and Northwell Health. They define specifically what will be done, to whom and when, and who will be responsible for costs. The CTO will manage, negotiate and finalize contracting. All contracts include a finalized and mutually agreed upon budget as an exhibit or appendix to the contract language itself. The budget will be negotiated by our finance team in the CTO.
In order to be able to assist you, we will need the following documentation:
- Consent Form
- Sponsor/CRO contract template (unless they request to use ours)
- Budget template
- Sponsor/CRO contact information for budget and contract negotiations
- Completed CTO Routing Form
*Please note that your package is considered incomplete until we receive all of these documents. We are unable to begin negotiations until we receive a complete package as we need this information to be able to do our job efficiently.
Your fully complete package should be uploaded to the IRBManager, our online submissions program. Once the CTO receives your complete package and it’s been assigned to a finance and contracts team member, we will contact you to advise who will be your point of contact for contract and budget negotiations.
Data Use Agreements
A Data Use Agreement (DUA) is a contractual document used for the transfer of data that is nonpublic or is otherwise subject to some restrictions on its use. Often, this data is a necessary component of a research project and it may or may not be human subject data from a clinical trial, or a Limited Data Set as defined in HIPAA.
Northwell Health wants to ensure that DUA terms protect confidentiality when necessary, but permit appropriate publication and sharing of research results in accordance with policies, applicable laws and regulations, and federal requirements. DUAs are similar to confidentiality agreements in that they restrict the use and disclosure of the data set, and, in some cases, a CDA format may be used as a starting point to build a DUA appropriate for the transfer of data.
DUAs are reviewed by the Contracts Division of the CTO.
All research studies that meet the definition of an applicable clinical trial must be registered on ClinicalTrials.gov. ClinicalTrials.gov is a web-based registry and results database maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH) that provides the public with easy access to information on publicly and privately funded clinical research studies.
Amanda Galvin is the main contact for those who need assistance or have any questions with ClinicalTrials.gov. Amanda can be reached at (516) 881-7033 or firstname.lastname@example.org.