clinical-trial-investigator-agreement

name	clinical-trial-investigator-agreement
title	Clinical Trial Investigator Agreement
description	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.
author	CaseMark
author_url	https://github.com/CaseMark/skills/tree/main/skills/legal/clinical-trial-investigator-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 Investigator Agreement

Drafts a sponsor–PI/site agreement that operationalizes FDA, IRB, and GCP obligations for a specific clinical trial.

Prerequisites

1. Protocol number, title, version date, phase, endpoints, enrollment target.
2. Investigator's brochure or device manual; investigational product handling requirements.
3. Sponsor identity, CRO involvement, contracting structure (institution, PI, or both).
4. Site legal name, state law, institutional policies, and any required template language.
5. PI credentials, sub-investigators, study team roles.
6. Budget and payment model (per subject, per visit, milestones); invoicing rules.
7. IRB details, consent/assent forms, recruitment materials, vulnerable population plan.
8. Data ownership, publication expectations, IP posture, sample handling.
9. Insurance positions and indemnity constraints (public entities, academic limits).

Output Structure / Process

1. Intake — targeted questions; confirm drug/biologic (21 CFR 312) vs device (21 CFR 812) track.
2. Draft — follow the section order below, incorporating site-specific policies.
3. Exhibits — attach and incorporate by reference.
4. Verify — run compliance checks using the tables and checklist below.

Regulatory Baseline

Topic	Authority
Informed consent	21 CFR Part 50; LAR, assent where required
IRB	21 CFR Part 56; 45 CFR 46 when institution requires
Drugs/Biologics	21 CFR Part 312; IND obligations flow down
Devices	21 CFR Part 812; IDE obligations flow down
GCP	ICH GCP E6(R2)
Financial disclosure	21 CFR Part 54
Privacy	HIPAA and state privacy laws
Vulnerable populations	45 CFR 46 Subparts B, C, D

Agreement Sections

Section	Must Include
Parties and Definitions	Sponsor, institution, PI; define Study, Protocol, Investigational Product, SAE, Confidential Information