investigator-agreement

name	investigator-agreement
title	Investigator Agreement
description	Drafts Investigator Agreements for FDA-regulated clinical trials between sponsors and principal investigators. Covers 21 CFR Parts 50, 56, 312/812, ICH GCP E6(R2), IRB governance, data integrity, IP, indemnification, financial terms, and termination. Use when preparing clinical trial investigator agreements, site agreements, PI agreements, or sponsor-investigator contracts for drug, biologic, or device studies.
author	CaseMark
author_url	https://github.com/CaseMark/skills/tree/main/skills/legal/investigator-agreement
license	Apache-2.0
version	0.1.0
execution_mode	open
jurisdiction	us
practice	life-sciences
language	en

Investigator Agreement

Drafts a legally enforceable agreement governing the sponsor–principal investigator relationship for FDA-regulated clinical research.

Prerequisites

Gather before drafting:

1. Protocol — number, version, phase, design, investigational product, indication, enrollment target, endpoints, special populations
2. Parties — sponsor type (pharma/biotech/device/academic/government), CRO if any, PI credentials, institution legal name and type, governing state
3. Contracting structure — PI individually, institution as primary with PI signatory, or joint
4. Site personnel — sub-investigators, coordinators, specialists
5. Prior agreements/templates — mandatory provisions, indemnification policies, payment processing
6. Budget — per-subject, per-procedure, or hybrid; fair market value basis
7. Single-site vs. multi-center — affects publication rights, data ownership, oversight

Quick Start

1. Collect all prerequisites above
2. Draft each section below, adapting to institutional type and study specifics
3. Replace all bracketed [X] placeholders with client-specific values
4. Run through the Drafting Checks at the end
5. 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