How to Review a Clinical Trial Agreement: a Clause-by-Clause Checklist

How do you review a clinical trial agreement? Review a clinical trial agreement (CTA) by checking that it protects trial participants, matches the approved protocol and the regulatory rules, and allocates money, risk, data and publication fairly between the sponsor, the site and the investigator. A CTA is unusual among commercial contracts because a third group, the trial participants, bears real risk, so the review is as much about safety and ethics as about commercial terms. Read the CTA alongside the protocol, the budget and the regulatory approvals. A clause that looks fine in isolation can conflict with the protocol or the law, so cross-check the three. This article is general guidance, not legal advice. The law here varies by jurisdiction and changes over time, so have a qualified lawyer review any agreement before you rely on it. ## The clause-by-clause review checklist ### Study, protocol and approvals

• Does the CTA reference the exact protocol number and version, and require strict compliance?
• Is the start and continuation of the study tied to valid regulatory approval and a registered ethics committee?
• Is Good Clinical Practice (and ICMR guidance in India) referenced?
• Is informed consent required before any study procedure, as the protocol and rules demand? ### Money
• Is the budget clear, with defined milestones (per participant, per visit, or by milestone)?
• Is it clear that no payment depends on reaching a particular result?
• Who pays for screen failures, protocol-required procedures, and overruns?
• Are pass-through costs and taxes handled? ### Participant safety (the clause regulators care about most)
• Is the sponsor responsible for medical management of study-related injury, for as long as needed?
• Is compensation for study-related injury or death provided, matching the law and the ethics committee's assessment?
• Does the sponsor carry clinical-trial insurance, and is proof required?
• Is adverse-event and serious-adverse-event reporting defined and compliant? ### Risk allocation
• Is the indemnity from the sponsor, covering the proper conduct of the study, with carve-outs only for the site's or investigator's own negligence or protocol/law breach?
• Is there a liability cap, and does it carve out injury, indemnity and confidentiality?
• Is indirect or consequential loss handled sensibly? ### Data, records and privacy
• Who owns the study data and results, and any intellectual property arising?
• Is the data-retention period stated, matching legal requirements?
• Are monitoring, audit and regulatory inspection rights included?
• Is participant personal and health data handled under applicable data-protection law, with de-identification where appropriate? ### Publication and confidentiality
• Can the investigator publish after a defined review window?
• Is the sponsor's right limited to a short delay (to protect patents or remove its confidential information), not a right to suppress or alter results?
• For multi-site studies, is there a fair rule on first (multi-site) publication? ### Term, termination and governing law
• Are termination grounds clear, and do participant safety and required reporting continue after termination?
• Is the governing law and dispute forum appropriate, especially for a cross-border sponsor? ## Clinical trial agreement red flags - Payment tied to results. Any link between payment and a particular outcome compromises the trial and is a serious red flag.
• Weak injury compensation. A compensation or medical-management clause narrower than the law or the ethics committee requires exposes participants and the site. In India this must match the New Drugs and Clinical Trials Rules, 2019.
• Sponsor control of publication. A clause that lets the sponsor suppress, edit or indefinitely delay results, rather than take a short, defined delay to protect patents, is both an ethical and a reputational risk.
• Indemnity gaps. An indemnity that does not cover the proper conduct of the study, or that shifts product-liability risk onto the site, is a red flag.
• No or capped injury liability. A liability cap that is not carved out for participant injury and the indemnity leaves the site exposed.
• Vague data ownership or missing inspection rights. Regulators must be able to inspect; the agreement must allow it.
• Ignoring data protection. Health data is sensitive; a CTA that does not address data-protection duties is incomplete. ## A note on jurisdiction Clinical trial rules are national and strict. In India the framework is the New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, administered by CDSCO and the DCGI, with registered ethics committees, mandatory injury compensation and medical management, and ICMR ethical guidelines. The United States (FDA regulations and the Common Rule), the United Kingdom, Ireland and the EU (the EU Clinical Trials Regulation and national law), Singapore and Australia each run their own approval, consent, compensation and data regimes, and international sponsors apply ICH Good Clinical Practice. When you review a CTA, check the compensation, insurance, data-protection and ownership clauses against the law of the country where the trial actually runs, rather than assume one standard fits all. ## Where a contract workspace helps This checklist helps you review one clinical trial agreement well. The ongoing work starts after signing: keeping terms consistent across many sponsors and sites, catching a weak indemnity or publication clause before you commit, and remembering reporting duties and approval dates as the study runs. Drafting, reviewing, tracking and governing clinical trial agreements can sit in one AI workspace tuned to how your institution contracts, rather than split across a drafting tool, a spreadsheet and a shared drive. A tool like Adira is built on exactly that principle.