casemark/clinical-trial-agreement
skills/legal/clinical-trial-agreement/SKILL.md
Drafts U.S. clinical trial agreements governing sponsor–site–investigator relationships under FDA rules (21 CFR Parts 50, 56, 312) and ICH-GCP E6(R2). Use when drafting or negotiating CTAs, sponsor research agreements, or protocol-specific contracts for investigational drugs, devices, or biologics.
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SKILL.md
- name:
- clinical-trial-agreement
- language:
- en
- description:
- >-
Clinical Trial Agreement
Draft a protocol-specific CTA governing study conduct, compliance, data rights, payments, and risk allocation.
Quick Start
Gather before drafting:
- Final or near-final protocol (number, version, phase, endpoints, schedule of events)
- Investigator Brochure or device manual with current safety profile
- Draft budget with FMV rationale and payment schedule
- Site policies on contracting, IP, publication, and indemnification
- Regulatory status: IND/IDE holder, IRB process, DSMB plan if any
Intake
Complete and confirm all fields before drafting.
| Field | Req | Notes | |---|---|---| | Sponsor name/address | Y | Include parent or funding affiliate | | Institution name/address | Y | Include hospital/academic entity | | Principal Investigator | Y | Note if individual signature needed | | Protocol title/number/version | Y | Attach as Exhibit A | | Phase and design | Y | Randomized, blinded, placebo, etc. | | Site enrollment target | Y | Min, max, or good-faith estimate | | IND/IDE holder and number | Y | Sponsor vs institution | | Investigational product | Y | Drug/device/biologic and comparators | | Central lab and vendors | If appl. | Include data flows | | Privacy model | Y | HIPAA auth vs waiver; de-ID plan | | Insurance limits | Y | Sponsor and institution coverage | | Publication plan | Y | Single-site vs multicenter | | Governing law/venue | Y | State selection | | Compensation model | Y | Per-subject, milestone, hybrid | | Closeout and retention | Y | Record retention period |
Agreement Sections
| Section | Required Content | |---|---| | Parties and Recitals | All parties; protocol reference; regulatory framework | | Definitions | Study, Protocol, Investigational Product, AE/SAE (21 CFR 312.32), GCP, Study Data, Confidential Information | | Study Conduct | Protocol incorporation; amendment process; investigator independence; facilities/staffing | | Sponsor Obligations | Product supply; training; monitoring; regulatory submissions; safety updates | | Site/Investigator Obligations | IRB approval; informed consent (21 CFR 50.27); records; protocol adherence; safety reporting | | Data and Records | Source data access; CRF completion; retention period | | Budget and Payment | FMV structure; invoicing; screen failures; early withdrawals; withholding rights | | Confidentiality and Privacy | Exceptions; HIPAA (45 CFR Parts 160, 164); de-identification | | IP and Publications | Data/invention ownership; review windows; multicenter restrictions | | Indemnification and Insurance | Mutual indemnity; product liability; limits; additional insureds | | Term and Termination | For cause/convenience; subject safety; wind-down; survival | | Dispute Resolution | Negotiation → mediation → arbitration/courts; injunctive relief | | Admin | Notices, assignment, amendment, severability, independent contractor |
Compliance Checklist
- [ ] IRB approval before study start and for amendments
- [ ] Informed consent meets 21 CFR Part 50
- [ ] IRB requirements per 21 CFR Part 56
- [ ] IND/IDE responsibilities per 21 CFR Part 312
- [ ] SAE reporting timelines defined; sponsor notification within 24 hours
- [ ] GCP reference to ICH E6(R2)
- [ ] Record retention ≥ 2 years after FDA approval or discontinuation
- [ ] HIPAA minimum necessary disclosure
- [ ] Conflict disclosure and exclusion/debarment status
- [ ] Anti-kickback and Stark Law compliance for compensation
Risk Tailoring
- [ ] High-risk product → higher insurance limits + enhanced safety monitoring
- [ ] Vulnerable populations → explicit consent safeguards
- [ ] Invasive procedures → explicit injury and compensation language
Exhibits
- A: Protocol
- B: Budget and payment schedule
- C: Schedule of events/procedures (if separate)
Pitfalls
- Use exact protocol identifiers and dates — do not paraphrase protocol constraints.
- Define AE/SAE per 21 CFR 312.32. Mark
[VERIFY]if deviating. - Never promise sponsor control over investigator medical judgment.
- Keep publication review windows time-bounded (30–60 days).
- Compensation must be FMV, not tied to outcomes or referrals.
- If state law mandates clinical trial injury coverage, add state-specific language.
[VERIFY]if unsure. - Preserve subject safety obligations post-termination (follow-up and reporting).
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