Clinical Trial Basics: Clinical Trial Agreement (CTA)

CTA definition: What is the clinical trial agreement and why is it important?

A clinical trial agreement is a legal contract that manages the working relationship between the institution where the clinical trial is to be held, i.e., the trial site, the sponsor, and relevant CROs. In the case of multicenter clinical trials, each site must have a separate CTA. [¹]

Also known as a CTA (medical abbreviation), this document lays out all the responsibilities and obligations of each party and defines all terms of the study. [¹][²]

Who develops the clinical trial agreement?

Typically, a CTA is developed by the principal investigator. However, if funding for the clinical trial is secured, the sponsor or CRO may initiate it.[³]

What is the difference between a CTA and CDA?

A confidentiality disclosure agreement (CDA) is another important legal contract that must be signed during site selection.

However, unlike a CTA, it only relates to information sharing, meaning a CDA only dictates what clinical trial information a trial site can and cannot share with a third party. It also defines when and how information can be shared and with whom.[⁴]

What are the components of a clinical trial agreement?

While a clinical trial agreement differs from trial to trial, certain sections must be included in a CTA. Clinical trial sponsors and CROs need to include the basic components listed below: [³][⁵][⁶]

• Clinical trial description: an explanation that explicitly states the purpose of the clinical study, including salient points to ensure there is no confusion or room for assumption
• Payment schedule and terms: details that clarify the sponsor, CRO, and site expectations regarding trial deliverables, trigger payments, and payment timeframes.
• Sponsor, CRO, and site responsibilities: particulars of each party’s responsibilities in compliance with the study protocol and relevant federal and state laws and regulations. Specifics in this part include all management and operation tasks.
• Data records and monitoring: mutual agreement specifics determining who owns the data collected during the trial, how often sponsors can inspect and monitor data collection, and how long the trial will store the data after study completion.
• Intellectual property and publication rights: Details on who owns the trial results, findings, and data records and when clinical trial sites can publish any study-related writing with or without the sponsor’s approval.
• Insurance and indemnification terms: documented evidence on who is responsible for compensation if a third party, such as a trial participant, is injured or harmed during the clinical trial. Note that while it is normally the sponsors, that may not always be the case, like if the trial site fails to follow the study protocol.
• Dispute resolution guidelines: define how parties will mutually resolve issues to avoid escalation. For cases of legal action, this part also specifies which jurisdiction will manage the case, as the sponsor and trial may be in different locations.
• Contract termination terms: Details when the CTA can be terminated, i.e., in cases of fraud, federal non-compliance, and the sponsor’s business strategy change in the early stages of the trial.
• Terms for amending the CTA: how the clinical trial agreements can be updated to handle any unexpected situation during trial operations.