lev-os 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).