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Industry Initiated Clinical Research

Contracts & Budget Submission

What

The Financial Administration of Clinical Trials Services (FACTS) office reviews, negotiates and executes most clinical research agreements funded or supported by For-Profit (Industry) Entities.

The type of agreements FACTS manages includes:

  • Confidentiality Disclosure Agreements (CDA)
  • Clinical Trial Agreements (CTA)
  • Registry Agreements
  • Research Service Agreements
  • Consortium Agreements (if funding source is a for-profit entity)
  • Subawards and Site Agreements Incoming (when another institution holds the prime award, ISMMS is a site and the study is funded by a for-profit entity)
  • Subawards and Site Agreements Outgoing (when ISMMS holds the prime award and the study is funded by for-profit entity)
  • Amendments to existing for-profit agreements

Click here to learn more about each type of agreement.

How

All requests for review of a CTA or amendment must be submitted to FACTS through MediTract (FACTS).

When you submit your contract through MediTract, you will be asked to indicate who will be negotiating the budget. If the study team chooses to negotiate the budget, the FACTS office will reach out to the study team to obtain the final negotiated budget. For more information on the institutional resources available for budgeting, see Budget Development about Negotiation.

Note: Prior to submission, ensure the appropriate Department or Institute Specific approvals are obtained, if applicable.

When

Contract negotiation should occur concurrently with budget negotiations and IRB review.

Fees

Fees will be charged for the review of all industry funded clinical trial agreements including amendments. For more information, refer to  2022 FACTS and Institutional Fee Schedule/Industry Sponsored Clinical Trials .

Questions

Contact your FACTS Departmental Assigned Contract Specialist or call (646) 605-7251

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BRANY Exception

Contracts may be negotiated by the Biomedical Research Alliance of New York (BRANY) on behalf of ISMMS in the following circumstances:

  • BRANY Classic Studies – This term is used at ISMMS to refer to studies where the research opportunities are brought to the investigator by BRANY. BRANY provides contract negotiation, budget negotiation, IRB review, Medicare Coverage Analysis (MCA), and study invoicing services for these studies.
  • Other – To use BRANY for your study, contact the FACTS office for more details and for fee schedules.
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Agreements Signatory

These agreements must be signed by the Authorized Institutional Signatory Official in FACTS – Rosaria McEntee, Director of Finance.

Average Turnaround Time

4 to 6 Weeks

Negotiation Process Using MediTract

Resources

Research 411 Portal

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