Clinical Trial Agreements
Weill Medical College
of Cornell University
Institute for Clinical Research
Office of Clinical Trials Administration
Weill Medical College Clinical Trial Agreements 1
of Cornell University Updated September 15, 2006
Outline: The best way to work
with ICR
Who negotiates contracts for my department?
Where is the ICR located?
When do I contact ICR?
What is a Clinical Trial Agreement (CTA)?
Why is it important to have a CTA?
Sections Contained in a Typical CTA
Challenges in Negotiating a CTA
Other Types of Agreements
Confidentiality Disclosure Agreement (CDA), Non-Disclosure Agreement
(NDA)
Registry Agreement
Retrospective Studies
Sponsored Research Agreement (SRA)
Material Transfer Agreement (MTA)
How do I work most effectively with OCTA?
Weill Medical College Clinical Trial Agreements 2
of Cornell University Updated September 15, 2006
Who negotiates contracts for my
department?
Vanessa L. Blau vlb2003@med.cornell.edu 212.746.7636
-All divisions of Pediatrics
-Medicine—Hem/Onc -Pharmacology
-Ophthalmology -Public Health
Drew Davis abd2001@med.cornell.edu 212.746.7655
-All divisions of Medicine, excluding Hem/Onc
-Anesthesiology -Neurology & Neuroscience
-Cell & Developmental Biology -Otorhinolaryngology
-Genetic Medicine -Surgery—Vascular
M. Eugenia (Gina) Vergara mev2001@med.cornell.edu 212.746.7645
-All divisions of Surgery, excluding Vascular
-Biochemistry -Pathology
-Burn Center -Physiology
-Complimentary & Integrative Medicine -Psychiatry
-Dermatology -Radiology
-Microbiology & Immunology -Transplantation
-Neurosurgery -Trauma Center
-OB/GYN -Urology
Weill Medical College Clinical Trial Agreements 3
of Cornell University Updated September 15, 2006
Is there any easy way to determine
which office handles my project?
By using the 4 IHOP Criteria.
I-Intervention
H-Human Interaction
O-Outcomes
P-Prospective
Does your project meet all four
criteria?
Weill Medical College Clinical Trial Agreements 4
of Cornell University Updated September 15, 2006
Where is OCTA?
Office of Clinical Trials
Administration (OCTA)
is the grants & contracts
subdivision of the Institute
for Clinical Research (ICR),
a division of Research And Sponsored
Programs (RASP).
OCTA is currently located at 1300 York Avenue,
Box 305.
Our offices are located in room A-131.
Weill Medical College Clinical Trial Agreements 5
of Cornell University Updated September 15, 2006
When do I contact OCTA?
As soon as the sponsor contacts
you.
We help you to understand working with
the Sponsor, with previous contracts,
templates and master agreements with
each sponsor.
Submit a
Clinical Trial Synopsis Form.
Weill Medical College Clinical Trial Agreements 6
of Cornell University Updated September 15, 2006
What is a Clinical Trial Agreement?
A legally binding agreement that manages the
relationship between the Sponsor [typically
Industry] who may be providing:
Study Drug or Device
Financial Support
Proprietary Information
And the Institution [Weill Cornell] who may
be providing:
Data and/or Results
Publication, Input into Publication
Input into further Intellectual Property
Weill Medical College Clinical Trial Agreements 7
of Cornell University Updated September 15, 2006
Other Types of Agreements
Confidentiality Disclosure Agreements/Non-
Disclosure Agreements (CDA/NDA)
Agreements to ensure confidentiality of
proprietary data that Company gives to
Investigator in order to make a determination as
to whether or not he/she will participate in the
trial/research.
WCMC prefers that CDAs be between Company
& Investigator only
However, many companies request that CDAs be
between Company and WCMC.
Weill Medical College Clinical Trial Agreements 8
of Cornell University Updated September 15, 2006
Why is it important to have a CTA?
Allocation of
Risk
Responsibility
Money
Obligations
Protection of
Rights (academic, legal, intellectual
property)
Academic Integrity
Weill Medical College Clinical Trial Agreements 9
of Cornell University Updated September 15, 2006
Sections Contained in a Typical
Clinical Trial Agreement
Preamble Indemnification
Acknowledgements & Insurance
Responsibilities Subject Injury
Term & Termination Waiver of Consequential
Payment/Reimbursement Damages
of Costs Miscellaneous
HIPAA, Patient Privacy Export Controls
Publication Governing Law
Intellectual Property Dispute Resolution/
Arbitration/Mediation
Confidentiality/
Exhibits
Proprietary Information
Weill Medical College Clinical Trial Agreements 10
of Cornell University Updated September 15, 2006
Negotiation
Sponsor supplies a
template.
Specialist redlines
the document.
Go back and forth
with sponsor until
all points are
covered.
Get to “Yes”.
Weill Medical College Clinical Trial Agreements 11
of Cornell University Updated September 15, 2006
Challenges in Negotiating a CTA
Top 4 Hurdles
Compliance with Institutional policy
Indemnification
If company will not indemnify
If company requires mutual
indemnification
Insurance
If company does not carry minimum
levels of insurance
If company cannot prove liquid assets to
cover liabilities
Publication
If company requires “approval” of
publication
If company a requires a de facto
publication restriction
Weill Medical College Clinical Trial Agreements 12
of Cornell University Updated September 15, 2006
Uncle Sam wants You…..
To Be Compliant.
Contract language
must be consistent
with Federal, State &
WCMC Laws,
policies,
requirements, and
procedures.
Weill Medical College Clinical Trial Agreements 13
of Cornell University Updated September 15, 2006
Indemnification
WCMC is a non-profit educational institution,
Devoted to research and education.
*WCMC will not incur liability on behalf of Cornell
University that is not warranted by the normal
course of our business.*
There are four specific points that WCMC requires
in standard indemnification:
Any Provision of Services in connection with
the Study
Institution’s Participation in the Study
Sponsor’s Manufacturing Defect of the Study
Drug or Device
Negligent use of data
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of Cornell University Updated September 15, 2006
Insurance
The sponsor is responsible for
the primary burden of risk,
therefore they are required to
have minimum levels of
insurance, that are set by the
Risk Management Office, before
the Institution is able to
participate in the Study:
$3Million per Occurrence
$5Million in the Annual
Aggregate
*REQUIRES RISK
ASSESSMENT*
Weill Medical College Clinical Trial Agreements 15
of Cornell University Updated September 15, 2006
Publication
Scholarly publication is the
fundamental right and
responsibility of researchers and
the Institution. Sponsors may
review manuscripts prior to
publication, but may not require
terms that allow for “approval”
by the Sponsor.
30 days for the removal of
confidential information
additional 60 days for the filing
of patent applications.
Weill Medical College Clinical Trial Agreements 16
of Cornell University Updated September 15, 2006
Additional Challenges
-If company requires poor intellectual
property clauses.
-If company requires data/results to
remain confidential or the length
of confidentiality is unreasonable.
-If company will not agree to pay
subject injury reimbursements.
-If company will not pay WCMC’s
indirect cost rate of 33%.
Weill Medical College Clinical Trial Agreements 17
of Cornell University Updated September 15, 2006
How do I work most effectively
with ICR?
Alert your specialist
ASAP
We’re here to assist
Communication is key
Ask questions
Continue to provide new
information you receive
Help us help you
Synopsis
Routing Form
Financial Disclosures
Human Res. Billing
Analysis Form
Weill Medical College Clinical Trial Agreements 18
of Cornell University Updated September 15, 2006
How to “Pump Up” our Negotiating
Standpoint.
United Front.
Clear layout of
Goals.
Know who we are
dealing with.
Understand the
Challenges.
Weill Medical College Clinical Trial Agreements 19
of Cornell University Updated September 15, 2006
Thanks for Listening…
Weill Medical College Clinical Trial Agreements 20
of Cornell University Updated September 15, 2006