The JCTO provides dedicated personnel to negotiate contracts or agreements related to clinical trials. The negotiation process involves a dialogue between the relevant parties until an agreement is reached on the terms of the contract. These terms outline the responsibilities and conduct of each party as it relates to a clinical trial. This section describes the steps involved in negotiating and finalizing Confidential Disclosure Agreements (CDAs) and Clinical Trial Agreements (CTAs) and provides information on important contract provisions.
Negotiating a CDA
Prior to receipt of clinical trial documents the PI is often asked to sign a CDA. It is required that the JCTO reviews all CDAs prior to execution. The terms of the CDA are negotiated with specific attention to the following areas:
Confidential Information: The type of confidential information and the way in which it is treated is acceptable.
Length of confidentiality: The length of time the investigator is required to maintain confidentiality must be reasonable.
Exceptions to confidentiality: Confidential information should not include information that:
- Is at the time of disclosure, or hereafter becomes, publically available through no breach of the CDA by WCM.
- Is disclosed to WCM by a third-party entitled to disclose such information in a non-confidential manner.
- Is known to WCM prior to disclosure under the CDA.
- Can be documented to be independently developed by WCM.
- Is required by applicable law to be disclosed.
CTA supersedes CDA: The CDA must include language that ensures any subsequent clinical trial agreement supersedes the CDA.
Negotiating a CTA
Step 1. JCTO Review of Draft CTA
Upon receipt of the required documents the JCTO contracts specialist reviews the draft CTA to determine if it meets all regulatory and institutional requirements.
Step 2. Negotiations
The JCTO will draft the necessary revisions and submit them to the sponsor for review. The sponsor may accept some revisions and provide counter recommendations for others. This process continues as changes are suggested and then accepted or countered by each party until an agreement is reached.
Step 3: Finalization of CTA
Once all parties have reached an agreement the final version of the CTA is circulated for signature by the PI, WCM/NYP and the sponsor.
Step 4: Release of the fully executed CTA
The JCTO notifies the PI and IRB that the contract is fully executed.
Please note, the IRB requires notification of contract execution prior to release of initial IRB approval documents.
Status of Pending Contracts
The JCTO sends out weekly Investigator Reports. These reports provide an update on the status of all contracts currently under negotiation. For inquiries regarding your Investigator Report contact JCTOcontracts@med.cornell.edu.
Important Contract Provisions
Certain contract provisions have a significant impact on investigators and the academic integrity of the institution. The negotiation of these provisions may take longer than other provisions. Information regarding each of these provisions is provided below:
Indemnification means to compensate for loss or damage; to provide security for financial reimbursement to an individual in case of a specified loss incurred by the person.
In the case of a clinical trial, sponsor indemnification insures that our subjects and institution are appropriately covered for losses resulting from our participation in a clinical trial. WCM/NYP does not indemnify sponsors. This section of the contract is important because if we incur costs associated with subject participation these losses will be covered.
The sponsor carries the majority of the risk and is therefore required to have adequate insurance as determined by the WCM Risk Management Office before WCM/NYP will participate in a study. Sponsors must carry a significant amount of insurance against subject and institutional losses arising from participation in the clinical trial.
If a research subject is injured during the course of a clinical trial, the sponsor has an obligation to cover expenses related to the injury if it was caused by the study; it’s practices, or products, such as the investigational drug or device. Accordingly, the subject’s informed consent should reflect the protections to which the sponsor has agreed. A contracts specialist will review the informed consent form and request that adjustments be made to the language as necessary to ensure it is consistent with the CTA.
Scholarly publishing is a fundamental right and responsibility of researchers and institutions. Sponsors may review manuscripts prior to publication, but may not have final authority over approval. Publication clauses however typically grant the sponsor the ability to delay publication up to 30 days allowing for removal of confidential information as well as an additional 60 days for the filing of a patent application.
Intellectual property is property that results from original creative thought, as patents, copyright material and trademarks. During the course of a clinical trial the PI may either be the sole creator of intellectual property or a collaborator with the sponsor. The contract should set forth guidelines regarding inventions and who has ownership of them. The provision prevents the sponsor from gaining sole ownership of the investigators intellectual property.
Confidentiality is a set of rules that limits access or places restrictions on certain types of information. The contract should articulate each party’s obligations of confidentiality and explain what information is considered confidential, the length of time that the information must remain confidential and how it may be used.