1---2name: clinical-trial-investigator-agreement3description: Drafts U.S. clinical trial Investigator Agreements between sponsors/CROs and principal investigators or institutions for FDA-regulated drug, biologic, or device studies. Enforces 21 CFR Parts 50, 56, 312/812, ICH GCP E6(R2), HIPAA, IRB requirements, FMV/AKS payment compliance, data integrity, publication rights, IP ownership, indemnity, and audit access. Use when drafting investigator agreements, PI agreements, clinical trial site agreements, or sponsor-PI contracts; trigger keywords: investigator agreement, clinical trial agreement, PI agreement, FDA, IND, IDE, IRB, GCP, clinical research agreement, site agreement.4license: Apache-2.05---67# Clinical Trial Investigator Agreement89Drafts a sponsor–PI/site agreement that operationalizes FDA, IRB, and GCP obligations for a specific clinical trial.1011## Prerequisites12131. Protocol number, title, version date, phase, endpoints, enrollment target.142. Investigator's brochure or device manual; investigational product handling requirements.153. Sponsor identity, CRO involvement, contracting structure (institution, PI, or both).164. Site legal name, state law, institutional policies, and any required template language.175. PI credentials, sub-investigators, study team roles.186. Budget and payment model (per subject, per visit, milestones); invoicing rules.197. IRB details, consent/assent forms, recruitment materials, vulnerable population plan.208. Data ownership, publication expectations, IP posture, sample handling.219. Insurance positions and indemnity constraints (public entities, academic limits).2223## Output Structure / Process24251. **Intake** — targeted questions; confirm drug/biologic (21 CFR 312) vs device (21 CFR 812) track.262. **Draft** — follow the section order below, incorporating site-specific policies.273. **Exhibits** — attach and incorporate by reference.284. **Verify** — run compliance checks using the tables and checklist below.2930### Regulatory Baseline3132| Topic | Authority |33|---|---|34| Informed consent | 21 CFR Part 50; LAR, assent where required |35| IRB | 21 CFR Part 56; 45 CFR 46 when institution requires |36| Drugs/Biologics | 21 CFR Part 312; IND obligations flow down |37| Devices | 21 CFR Part 812; IDE obligations flow down |38| GCP | ICH GCP E6(R2) |39| Financial disclosure | 21 CFR Part 54 |40| Privacy | HIPAA and state privacy laws |41| Vulnerable populations | 45 CFR 46 Subparts B, C, D |4243### Agreement Sections4445| Section | Must Include |46|---|---|47| Parties and Definitions | Sponsor, institution, PI; define Study, Protocol, Investigational Product, SAE, Confidential Information |48| Study Description | Protocol incorporated by reference; scope; single vs multi-center |49| Investigator Responsibilities | Conduct per protocol; no deviations except to eliminate immediate hazard; amendment approval workflow |50| IRB and Approvals | No study activities before written IRB approval; continuing review; submissions shared with sponsor |51| Informed Consent | Current IRB-approved forms; qualified designee; no coercion; LAR and assent as applicable |52| Study Personnel | Delegation of authority log; training documentation; PI retains ultimate responsibility |53| Investigational Product | Receipt only from sponsor; storage conditions; accountability logs; no off-protocol use; return/destroy per sponsor |54| Safety Reporting | AE/SAE definitions; sponsor reporting timelines; IRB reporting for unanticipated problems |55| Data Integrity | ALCOA+; source data verification; correction rules; EDC audit trail |56| Records and Retention | Essential documents per ICH GCP § 8; retention per 21 CFR 312.62(c) / 812.140(d), or longer per law/policy |57| Monitoring and Access | Reasonable advance notice; direct source access; HIPAA minimum necessary; corrective actions |58| Regulatory Inspections | Notify sponsor within 24 hours; provide FDA 483 or correspondence within 5 business days |59| Confidentiality | Scope; permitted disclosures to IRB/regulators; term and return/destruction |60| Data and IP Ownership | Sponsor owns study data and results; invention assignment; sample ownership with institutional carve-outs |61| Publications | Sponsor review window; patent delay; multicenter coordination; ICMJE authorship standards |62| Compensation and Budget | FMV/AKS compliance; invoicing; screen fail and early withdrawal rules; startup/closeout costs |63| Financial Disclosure/COI | 21 CFR Part 54 disclosures; update obligations; conflict management |64| Indemnification | Sponsor product liability indemnity; carve-outs for PI/site negligence or noncompliance |65| Insurance | Sponsor clinical trial liability; site professional liability; certificate requirements |66| Term and Termination | For cause and convenience; subject safety wind-down; payment of earned fees |67| Governing Law/Disputes | State law selection; venue or negotiation/mediation steps |68| Compliance | FCPA/UK Bribery Act; export control/OFAC; Sunshine Act reporting |6970### Exhibits7172- [ ] Protocol and amendments73- [ ] Budget and payment schedule74- [ ] Study team roster and qualifications75- [ ] Financial disclosure forms76- [ ] Informed consent/assent forms77- [ ] Institutional policies incorporated by reference78- [ ] Publication policy (if separate)7980### Default Timelines8182Adjust to protocol/IRB policy.8384| Event | Default |85|---|---|86| Sponsor notification of SAE | Within 24 hours of awareness |87| IRB submission of unanticipated problems | Per IRB policy, prompt reporting |88| Publication review by sponsor | 45–60 days before submission |89| Patent delay after review | Up to 60–90 days |9091### Final Checks9293- [ ] Parties and governing law match site and sponsor94- [ ] All regulatory citations align with drug/biologic vs device track95- [ ] Consent and privacy requirements align with site policy96- [ ] Payment terms are FMV and AKS compliant97- [ ] Indemnity/insurance reflect institutional limits98- [ ] Every unverified citation marked `[VERIFY]`99100## Troubleshooting101102| Issue | Resolution |103|---|---|104| Unclear whether drug or device track applies | Confirm IND (21 CFR 312) vs IDE (21 CFR 812) with sponsor; combination products follow primary mode of action |105| Institution requires its own template | Merge sponsor terms into institutional template; flag conflicts for negotiation |106| Public entity cannot indemnify | Carve out sovereign immunity; shift to insurance-only model with higher certificate minimums |107| PI holds multiple roles (e.g., also sponsor-investigator) | Apply 21 CFR 312.50–312.70 sponsor obligations in addition to investigator duties |108| Budget exceeds FMV benchmarks | Document FMV analysis methodology; adjust per AAMC/PhRMA guidelines to avoid AKS risk |109110## Guidelines111112- Apply the most stringent requirement among federal law, state law, and institutional policy.113- No study activity before IRB approval and full execution if required by the institution.114- Keep confidentiality and publication clauses consistent with multi-center coordination.115- Preserve a clear audit trail for data corrections and monitoring access.116- Flag any unclear regulatory citation with `[VERIFY]`.117118---
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