Extract clauses from a clinical-trial agreement
Key facts
- Human involvement
- YellowClose supervision
- How AI is used
- Quote the clauses on data, publication, injury, and confidentiality, with the page. Note if the agreement says the research is federally supported. Do not compare the agreement to a standard form.
- What the lawyer must review
- You decide whether the agreement is acceptable. No standard clinical-trial form was opened, so there is nothing in this check to match it against. If the research is human-subjects research conducted, supported, or regulated by a federal department that has made 45 CFR § 46.101 applicable, that section says the institution and the reviewing board must comply with the policy. The exemptions in § 46.104 were not opened. 45 CFR § 164.502 limits use and disclosure of health information. Formal Opinion 512 applies to the agreement.
- Written for / version
- United States versionUS
Who does what
| Role | What they do |
|---|---|
| Assistance | Potential support includes organising research leads and preparing preliminary structure or wording. Confirm the tool’s capability and permitted scope. |
| Lawyer | Set the scope, supervise the work closely, verify every part relied on, resolve omissions and exceptions, and approve the exact output. |
Checklist
- Review operative clauses in the complete document, including definitions, cross-references, schedules and inconsistencies with the instructions.
- Verify the applicable jurisdiction and the version of each relevant law, rule or instrument in force at the material time.
- Confirm the output against the client’s instructions and the complete relevant source material, including omissions or contradictions.
- Resolve exceptions and record the responsible lawyer’s approval of the exact output and intended use.