Joint Clinical Trials Office
Lee C. Stetson, J.D.
Assistant Director, Contracts and Compliance
April 2016
jcto.weill.cornell.edu
JCTO Contracts
Joint Clinical Trials Office
Updates First!
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CTA Submissions through CSEC Part A application
• All CTAs should be submitted through REDCap via the CSEC
Part A application as of March 22nd!
• The Clinical Trial Synopsis Form is no longer required.
• Part A will allow you to upload the CTA document, so when you
submit your Part A application, an email will automatically be
submitted to JCTO Contracts.
Joint Clinical Trials Office
Updates continued
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Enhanced Investigator Report
• First issued on March 4
th
.
• Features streamlined, user-friendly format for greater readability.
• Investigators can review the report easily on their mobile device,
and can contact the appropriate JCTO or OSRA contract specialist
directly from the report.
• Please let us know if you want to be added to your investigator’s
report.
Email [email protected]
Joint Clinical Trials Office
Sample Enhanced Investigator Report
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Joint Clinical Trials Office
JCTO Contracts Overview
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• Negotiate clinical trial agreements and related
clinical research contracts
• Advise research teams on matters of contract
compliance
• Produce weekly investigator reports
• Review informed consent forms to ensure
consistency with contractual subject injury
protections
• Release completed contracts to the IRB
Joint Clinical Trials Office
Types of contracts managed by the
JCTO
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• Industry-sponsored clinical trial agreements
• Investigator-initiated clinical trial agreements
• Confidentiality agreements
• Contract amendments
• Data use agreements
• Registry agreements
• Clinical material transfer agreements
• Clinical services agreements
• Master clinical trial agreements
Joint Clinical Trials Office
What is a Confidentiality Agreement?
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• Confidential Disclosure Agreement (CDA) or Non-
Disclosure Agreement (NDA) obligates one or both
parties to maintain the confidential information of the
other.
• Often required by sponsors before they disclose their
protocol to our investigator.
• JCTO Contracts needs to know whether your
investigator is disclosing information, or only receiving.
• All CDAs must be submitted to JCTO Contracts.
• If your investigator is sharing an investigator-initiated
protocol with another site or a sponsor, it is strongly
recommended that a CDA be put in place.
Joint Clinical Trials Office
What is a Clinical Trial Agreement?
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• A clinical trial agreement (“CTA”) is a legally binding document that
establishes and defines the relationship between WCM-NYPH and the
sponsor or WCM-NYPH and the sub-site, with respect to conducting a
clinical trial.
• The sponsor typically provides study drug or device, financial support,
and/or proprietary information.
• WCM-NYPH provides data, publications, intellectual property, and/or
medical expertise.
• If WCM-NYPH is the prime site, we may provide funding, drug, or
proprietary information.
Joint Clinical Trials Office
What is a CTA Amendment?
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• Simply put, an amendment is a document that changes the terms of an
existing contract.
• In the context of clinical trials, CTA amendments are used to account for
changing circumstances during a trial.
• Most often CTA amendments are issued by the sponsor, and they
involve alterations to the budget.
• JCTO Contracts should review each amendment because
amendments, like CTAs, require all parties to agree.
Joint Clinical Trials Office
How does the contract impact how I
operate my clinical trial?
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• Data Collection/case report forms
• Invoicing/Payments
• Subject enrollment
• Adverse Event Reporting
• Record retention
• Legal Ramifications
• Publication timelines
• Subject injury compensation
Joint Clinical Trials Office
What can I do while the contract is
under negotiation?
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• Complete CSEC and IRB review processes.
• Negotiate budget and payment terms and submit to JCTO Finance.
• Review weekly investigator reports for updates in the contract
negotiation process.
• Answer questions from JCTO Contracts during the course of
negotiation.
• Send the final draft informed consent form to JCTO Contracts to review
injury language.
Joint Clinical Trials Office
Key Contract Provisions: Publication
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• We must protect WCM-NYPH’s academic freedom to
publish scientific data.
• Sponsors will want the right to review manuscripts.
• Sponsors will want us to remove confidential
information.
• We may need to wait to publish until a multi-center
publication is released.
Joint Clinical Trials Office
Key Contract Provisions:
Indemnification
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• Indemnification is the process by which one party
promises to provide compensation for another party’s
loss.
• In sponsored clinical trials, the sponsor agrees to
take on substantial risk because it is manufacturing the
drug/device and initiating the trial: they should
“indemnify” WCM-NYPH for any loss experienced
during the trial.
• WCM-NYPH should also receive some limited
indemnity for investigator-initiated trials.
• WCM-NYPH does NOT indemnify!
Joint Clinical Trials Office
Key Contract Provisions: Intellectual
Property
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• When an “invention” is made during a sponsored trial
by using the sponsor’s product, the sponsor will want to
own it.
• An invention in the context of a clinical trial may be a
new use or indication of the study drug.
• Even if the sponsor insists on owning new inventions
related to their drug/device, WCM-NYPH should retain a
non-exclusive license to use the invention for academic
non-commercial purposes.
• For investigator-initiated trials WCM-NYPH should
seek ownership of inventions made using our
investigator-initiated protocol.
Joint Clinical Trials Office
Key Contract Provisions: Subject Injury
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• For sponsored trials, the sponsor should reimburse WCM-NYPH
and/or the study subject for injuries that result from participation in
the trial.
• This is distinguishable from indemnity because here the
company is directly paying for medical care, versus indemnity
where the sponsor is representing WCM-NYPH in court.
• This is considered an ethical obligation of the sponsor to take
responsibility for adverse events that result from the proper use of
their drug/device.
• It is common to not receive subject injury protection in
investigator-initiated trials because the company did not design the
protocol.
• The informed consent form must correctly advise the subject
whether or not the sponsor is providing subject injury coverage.
Joint Clinical Trials Office
Key Contract Provisions: Data
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• Sponsors will want to review study data.
• The contract will indicate that the collection,
transmission, and inspection of data will be in
accordance with the informed consent form.
• For sponsored trials, the sponsor will seek to own the
data, and WCM-NYPH will retain the right to publish
and use the data for non-commercial research.
• For investigator-initiated trials, WCM-NYPH should
own all data.
• WCM-NYPH always owns medical records.
Joint Clinical Trials Office
Contact us!
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JCTO Contracts
575 Lexington Avenue, 9
th
Floor
New York, NY 10065
646-962-8215
Lee C. Stetson, J.D.
Assistant Director, Contracts & Compliance
Ari Goldman, J.D.
Senior Contracts Specialist
Helen Martirosova, M.S.
Senior Contracts Specialist
Kerilee Tam, J.D.
Senior Contracts Specialist
Helen Barkhudaryan
Contracts Administrator
