Clinical Trial Agreement Template

CLINICAL TRIAL AGREEMENT TEMPLATE FAQ

What is a clinical trial agreement?

A Clinical Trial Agreement (CTA) is a contract between a study Sponsor and a research site (often a hospital, university, or clinic) that sets the legal and operational rules for running a clinical study. It covers who does what, how participants are protected, how the site is paid, how data is handled, and what happens if the study changes or ends early.

Who usually signs a clinical trial agreement?

Most CTAs are signed by the Sponsor and the Institution/Site. The Principal Investigator (PI) may also sign to confirm certain responsibilities, depending on the Institution’s policy. If a CRO manages the study for the Sponsor, the CRO may be referenced or included, but the Sponsor typically remains responsible for core obligations.

What should be included in a clinical trial agreement?

Common sections include the protocol reference, regulatory and IRB requirements, site and sponsor responsibilities, monitoring/audit access, safety reporting rules, budget and payment schedule, subject injury and reimbursement terms, confidentiality, data ownership and publication rules, intellectual property, privacy/HIPAA expectations (if applicable), insurance/indemnification, and termination/close-out steps.

How do payments usually work in a CTA?

Payments are often tied to milestones (start-up, per-subject visits, close-out) and may include pass-through costs (labs, imaging, pharmacy) plus overhead. A good CTA clearly defines what is billable, how screen failures and early withdrawals are paid, invoicing frequency, and when payment is due.

Who owns the data and can the site publish results?

Often, the Sponsor controls study-level data and regulatory reporting, while the Site retains its own records and may publish results after the Sponsor gets a limited review period to protect confidential information and potential patents. The agreement should include clear timelines so publication is not delayed indefinitely.

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