What

When a sponsor (organization and/or person responsible for the conduct of a clinical investigation) or Contract Research Organization (CRO) reaches out to an investigator with a potential clinical trial opportunity, they may provide the investigator with a Confidential Disclosure Agreement (CDA), also referred to as Non-Disclosure Agreement (NDA). This legal agreement governs the disclosure of confidential or proprietary information as it relates to a clinical research study. Sponsors will often require an executed CDA in order to release the study protocol.

How

A Word document of the CDA must be submitted to FACTS via the MediTract (FACTS) System.

Who

The Financial Administration of Clinical Trials Services (FACTS) office is responsible for reviewing, negotiating and executing all industry sponsored CDAs on behalf of investigators at ISMMS.

The FACTS Authorized Signatory Official is Rosaria McEntee, Director of Finance.

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Department Specific Requirements

Department of Medicine: All CDA’s in the Department of Medicine must go through the CTO Administrative Director, Michele Cohen. For CDA’s being processed for Sub-Agreements, Grants, or Foundation studies, please submit to the GCO office.

Exceptions – Cardiology & Oncology Divisions

Cardiology: All CDA’s in the Cardiology Division must be submitted to the Cardiology Clinical Research Manager, Debra Fitzpatrick.

Hematology and Medical Oncology: Contact the Assistant Director of Regulatory Affairs, Tiffany Drummond, if there are questions regarding CDA submission.

CDA Signatory

ISMMS investigators may not sign a CDA prior to FACTS. CDAs are legally binding agreements and must be signed by an authorized ISMMS Signatory Official.

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