The document provides a 10-point checklist for contractual negotiations between sponsors and clinical research organizations. The checklist ensures that expectations are communicated and included in the contract, tasks are delegated to qualified individuals, intellectual property ownership is clear, confidentiality is addressed, data ownership and maintenance is established, procedures for non-compliance are in place, an escalation process for resolving disputes is included, protections for employees are addressed, termination terms are defined.

1. Paul G. Nardulli, Esq.
Optima Law Group, APC
9990 Mesa Rim Road, Suite 250
San Diego, CA 92121
(858) 526.6564
paul@optimalawgroup.com
Checklist for Contractual Negotiations
Between Sponsors and Clinical Research Organizations
1. Have your expectations from the relationship been communicated 
to each other and have they made their way into the contract?
2. Does the contract provide mechanisms to ensure tasks inside and
outside the CRO are delegated to qualified people?

3. Is it clear what rights the parties have to the development
Process and future use?

4. Have you adequately addressed confidentiality between the
parties and extending to involved third parties that will have
access to confidential information?

5. Have you addressed who will own resulting data and who will
maintain the data?

6. Have you put procedures/requirements in place to cover you if
the other party does not live up to obligations?

7. Have you included an escalation process to assist in resolving
Disputes early and out of court?

8. Have you included language to protect your other resources,
such as your employees?

9. Is it crystal clear who owns all intellectual property created and
what right, if any, the other party has to use it?

10. Have you addressed when termination is allowed, what notice is
required, and what timely steps must then be taken?
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