lev-os Investigator Agreement
Drafts a legally enforceable agreement governing the sponsor–principal investigator relationship for FDA-regulated clinical research.
Prerequisites
Gather before drafting:
- Protocol — number, version, phase, design, investigational product, indication, enrollment target, endpoints, special populations
- Parties — sponsor type (pharma/biotech/device/academic/government), CRO if any, PI credentials, institution legal name and type, governing state
- Contracting structure — PI individually, institution as primary with PI signatory, or joint
- Site personnel — sub-investigators, coordinators, specialists
- Prior agreements/templates — mandatory provisions, indemnification policies, payment processing
- Budget — per-subject, per-procedure, or hybrid; fair market value basis
- Single-site vs. multi-center — affects publication rights, data ownership, oversight
Quick Start
- Collect all prerequisites above
- Draft each section below, adapting to institutional type and study specifics
- Replace all bracketed
[X]placeholders with client-specific values - Run through the Drafting Checks at the end
- For detailed regulatory tables and reference material, see references/REGULATORY.md
Agreement Sections
1. Recitals & Definitions
- Full legal names and roles for all parties
- Define: Protocol, Investigational Product, Study Site, Confidential Information, Study Data, Serious Adverse Event, Effective Date, Study Completion
2. Investigator Obligations
Key regulatory obligations to address:
| Obligation | Regulatory Basis | Core Requirement |
|---|---|---|
| Protocol compliance | 21 CFR 312.60 / 812.110 | Absolute; deviations only for immediate hazard; report within 24 hrs |
| Delegation | ICH E6(R2) §4.2 | Signed delegation log; PI retains ultimate responsibility |
| IP accountability | 21 CFR 312.62 / 812.140 | Receipt, storage, dispensing, return/destruction records |
| Informed consent | 21 CFR 50; ICH E6(R2) §4.8 | Written consent before any study procedure; current IRB-approved form |
| Vulnerable populations | 45 CFR 46 Subparts B/C/D | Additional protections; immediate notification for status changes |
| HIPAA | 45 CFR 164 | PHI authorization; coded CRF identifiers; breach reporting |
3. IRB Governance
- Initial submission: Complete package before any subject contact
- Continuing review: Per IRB schedule with enrollment counts, AE summary, deviations
- Amendments: IRB + sponsor approval before implementation; exception for immediate hazard (document, notify within 24 hrs)
- Reporting: SAEs (unexpected + possibly related), unanticipated problems, deviations increasing risk
- Lapse: Cease all activities; exception for enrolled subject safety monitoring
- Document flow: IRB submissions/correspondence to sponsor within 5 business days
4. Data Integrity & Documentation
- Apply ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Available, Consistent, Enduring, Traceable)
- All CRF entries verifiable against source documents
- Corrections: single line-through (paper) or audit trail (EDC); date, initial, reason
- Essential documents per ICH E6(R2) §8 — FDA 1572, financial disclosures, IRB correspondence, signed ICFs, delegation log, IP records, protocol versions, lab certifications
- Retention: longest of — 2 years post-marketing approval (or 2 years post-discontinuation + FDA notification), institutional policy, or state law; notify sponsor before destruction
5. Adverse Event Reporting
| Category | Timeline | Recipient |
|---|---|---|
| All AEs | Document regardless of severity/causality | Study file |
| SAEs | Within 24 hours of awareness | Sponsor |
| Unanticipated problems involving risk | Per IRB policy | IRB |
| Sponsor safety reports | Review + submit per IRB policy | IRB |
6. Monitoring & Inspection
- Sponsor monitoring: Business hours; ≥1 week notice (except urgent); direct source document access; PI responds promptly to findings
- Regulatory inspections: Notify sponsor within 24 hours of FDA/authority contact; cooperate fully; provide copies of FDA 483, EIR, warning letters within 5 business days
- Corrective actions: Collaborative development with sponsor; document implementation
7. Confidentiality & IP
- Scope: Protocol, IB, CRFs, study data, product formulation, regulatory strategy, all non-public sponsor information
- Duration: Study term + [3–5] years post-termination or until publicly available
- Permitted disclosures: IRB, regulators, study personnel (bound by equivalent obligations), legal counsel
- Return/destruction: Upon request or termination; retain one regulatory copy; certify electronic deletion
- Data ownership: Sponsor owns all data, results, discoveries, inventions; survives termination
- Biological samples: Sponsor-owned; subject to institutional policies on genetic testing/destruction
8. Publication Rights
- Eligible after study completion + database lock + primary analyses
- Review period: Submit to sponsor [45–60] days before submission/presentation
- Sponsor rights: Remove confidential information; delay [60–90] days for patent filing; request accuracy modifications
- Anti-suppression: Sponsor may not suppress legitimate scientific findings; independent expert dispute resolution
- Authorship: Per ICMJE guidelines
9. Financial Terms
- Compensation: Per-subject/per-procedure/hybrid; attach itemized budget as exhibit
- Fair market value: Based on time, effort, complexity, qualifications, local rates; Anti-Kickback Statute compliant
- Invoicing: [Monthly/quarterly]; payment within [30–45] days of compliant invoice
- Adjustments: Screen failures at [specified rate]; early withdrawals pro rata; no payment for unusable data from PI non-compliance
- Reimbursable costs: Protocol-required labs/imaging, pharmacy fees, IP storage, subject stipends/travel; pre-approval above [threshold]
- Financial disclosure: Per 21 CFR 54 — equity >$50K, prior-year compensation >$25K (excluding study payments), proprietary interests; update during study
10. Indemnification & Insurance
Sponsor indemnifies for: protocol design, IP formulation/manufacture/defects, product-related injuries when used per protocol.
Exceptions: PI negligence/willful misconduct, failure to follow informed consent, unauthorized deviations, agreement breach, regulatory non-compliance.
Insurance minimums:
| Party | Per Occurrence | Aggregate |
|---|---|---|
| Sponsor (clinical trial liability) | $[1–5]M | $[2–10]M |
| PI/Institution (professional liability) | $[1–3]M | $[3–5]M |
- Certificates of insurance required; 10-day claims notice; indemnifying party controls defense
- Academic/public institutions typically cannot indemnify — rely on professional liability insurance with specified minimums instead
11. Term & Termination
| Trigger | Notice | Effect |
|---|---|---|
| Study completion | N/A | Ends after closeout complete |
| Sponsor convenience | [30–60] days written | Payment through termination + wind-down costs |
| Sponsor for cause | Immediate | May seek damages; may report to FDA/ORI |
| PI — sponsor breach | 30-day cure period | Effective after cure period |
| PI — sponsor insurance lapse | Written notice | Effective upon notice |
Wind-down: PI ceases enrollment, notifies subjects, completes CRFs, returns IP/confidential info, submits final IRB report. Sponsor pays for completed services and reasonable wind-down costs.
12. Governing Law & Disputes
- Governing law: [Sponsor's state] for contract; site jurisdiction for research conduct/malpractice
- Escalation: project managers → institutional/sponsor executives → mediation (shared costs) → litigation
- Consider arbitration based on party preferences
13. Representations & Warranties
- Sponsor: Authority to contract; effective IND/IDE; IB contains all known safety information; will maintain insurance; IP manufactured per regulations
- PI: Authority to contract; qualified and licensed; disclosed all financial interests; adequate facilities/personnel; not debarred from clinical research
- Disclaimer: No implied warranties; investigational product is experimental
14. Compliance Provisions
- Anti-corruption: FCPA/UK Bribery Act; if PI is government official, institutional compliance review; immediate termination for violation
- Export controls/sanctions: PI not on OFAC/SDN lists; no export of IP to restricted parties
- Healthcare compliance: Anti-Kickback Statute, False Claims Act, Sunshine Act; compensation = FMV
15. Execution & Exhibits
- Signature blocks: Authorized institutional official (not just PI) for institutional agreements; PI signature for personal obligations
- Startup timeline: Allow [6–12] weeks for institutional review
- Exhibits: A: Protocol, B: Budget, C: Personnel List, D: PI CV, E: Financial Disclosures, F: Institutional Policies
- Amendments: Material changes require written amendment signed by both parties
Drafting Checks
- All
[X]placeholders replaced with client-specific values - Contracting structure and indemnification adapted to institutional type (academic centers typically cannot indemnify)
- For device studies, 21 CFR 812 substituted for Part 312 references throughout
- Publication terms include ICMJE-compliant authorship and anti-suppression language
- Financial terms withstand fair market value scrutiny under Anti-Kickback Statute
- Multi-center provisions address publication timing and data consistency coordination
- State-specific requirements checked (informed consent, medical records retention)
- All regulatory citations verified against current CFR versions