| name | clinical-trial-agreement |
| title | Clinical Trial Agreement |
| description | 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. |
| author | CaseMark |
| author_url | https://github.com/CaseMark/skills/tree/main/skills/legal/clinical-trial-agreement |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | life-sciences |
| language | en |
| tags | ["agreement","drafting","regulatory"] |
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
