Clinical Trial Contracts: Everything You Need to Know
Clinical trial contracts stipulates the obligations, roles, responsibilities, terms, and conditions of each party involved in a clinical trial.3 min read
Clinical trial contracts are agreements that stipulate the obligations, roles, responsibilities, terms, and conditions of each party involved in a clinical trial. In most cases, a study will not begin until the clinical trial agreement (CTA) is fully executed and signed by all parties.
Types of CTAs
- Industry-sponsored CTAs can be sponsored by either the principal investigator (PI) or research sponsor. In many cases, the sponsor must initiate the CTA in an industry-sponsored clinical trial in which the sponsor provides funding and/or a study drug or device. When the investigator initiates the trial, the investigator-sponsored CTA is required.
- Academic institution CTAs are typically used for subcontracts or subawards in which the lead trial site seeks the assistance of a subsidiary site.
Most institutions require specific documents to begin CTA review, including but not limited to a clinical trials synopsis form, informed consent form, and study protocol. When an amendment to the contract is required, that must also be provided for review.
Language and Limitations
Trials overseen by the U.S. Food and Drug Administration (FDA) require the creation of a CTA agreement between the clinical research organization (CRO) and site sponsor. The language of these contracts is often complex, so it's important to understand commonly used terms or seek the assistance of legal counsel where necessary to avoid accidental contract breach and subsequent consequences.
CTA agreements can be written in plain language rather than legal jargon and will still be binding. The ideal agreement is clear to all parties and thoroughly details the tasks, deliverables, and responsibilities of each party.
Goals of a sponsor include:
- Collecting data that supports their marketing application for FDA approval
- Protecting confidential information and IP
- Complying with all laws and regulations
Site goals include:
- Fair compensation for its work
- The right to publish the results of the study
- Compensation for subject injury
When reading a CTA, note the words you don't understand and ask for definitions. The contract should include a section defining unfamiliar words. Also take note of capitalized words, which are important and may be used in an unfamiliar way.
Be aware of limiting language, which includes terms such as without limitations, all, or any. Stipulations with these words require the site to drop everything to deal with issues and questions from the sponsor. Instead of limiting language, the contract should include detailed expectations of both the site and the sponsor.
For example, the site should not be required to drop everything to alleviate an unexpected issue; instead, they should be required to promptly notify the sponsor about the issue and take steps to investigate and make a report within a reasonable amount of time, such as 7 to ten business days.
Language such as best efforts should be changed to reasonable efforts. Reasonable discretion is preferable to sole discretion.
Reasonable Site Protections
Study staff that have been debarred from conducting investigations by the FDA may not participate in a clinical trial. Avoid signing a contract that places the onus on the site to report anyone at the institution in any capacity who has been debarred. This would require you to report all debarred staff to the FDA even if they are not working directly on this study.
Avoid signing a contract in which the sponsor has editorial control over PI publications. The sponsor should be given a reasonable timeline, such as 60 days, to review only for the purpose of removing confidential information.
Avoid signing a contract in which the site will be responsible for storing and maintaining study records indefinitely. Two years is a reasonable duration unless the sponsor can provide reasonable justification for storing site data longer.
The sponsor must be responsible for payments due to the site even if the contract research organization (CRO) does not make payments to the sponsor as agreed. Avoid contract language that indicates that site payments are tied to case report review, as this could delay payment for weeks or months.
Confidential information should be clearly identified by the sponsor in the contract. This should include specific documents so the site can effectively avoid accidentally sharing confidential information. Confidential information that can be shared verbally but not in writing should be marked as such.
The PI's main responsibility is ensuring that subjects are safe from injury and that their diagnosis and treatment costs are paid for. The contract should indicate that the PI, not the sponsor, makes the determination about whether subject injury has occurred.
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