Investigator Agreement

Draft Clinical Trial Investigator Agreements in Minutes

14 minutes with CaseMark

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14 minutes with CaseMark

What you'll need

Clinical Trial Protocol
Party and Site Information
Budget and Financial Terms

SOC 2 Type II · HIPAA compliant · $5 free credit

Workflow

Overview

CaseMark's Investigator Agreement skill automates the drafting of legally enforceable contracts governing the sponsor–principal investigator relationship for FDA-regulated clinical research. The AI maps every investigator obligation to its specific regulatory basis across 21 CFR and ICH GCP frameworks, producing comprehensive agreements that cover protocol compliance, IRB governance, data integrity, intellectual property, indemnification, and financial terms. What traditionally takes hours of manual drafting and regulatory cross-referencing is completed in minutes with full compliance coverage.

Drafting Investigator Agreements for FDA-regulated clinical trials is a complex, time-intensive process requiring deep knowledge of overlapping regulatory frameworks, institutional policies, and trial-specific requirements. Legal and regulatory teams must manually cross-reference 21 CFR provisions, ICH GCP guidelines, IRB requirements, and financial compliance standards—often spending hours or days on a single agreement while risking gaps that could jeopardize study compliance or delay site activation.

CaseMark's AI-powered Investigator Agreement skill transforms this process by automatically generating comprehensive, regulation-mapped agreements from your protocol and party details. The AI cross-references applicable FDA regulations and ICH GCP requirements, drafts all necessary provisions from investigator obligations to termination clauses, and includes built-in compliance checks—delivering a complete, review-ready agreement in approximately 14 minutes.

How it works

1. Upload your clinical trial protocol, party details, and budget terms
2. AI analyzes regulatory requirements and drafts a comprehensive Investigator Agreement
3. Review and customize provisions for your specific trial structure and institutional policies
4. Export the finalized agreement in your preferred format (DOCX, PDF)

What you get

Recitals & Definitions
Investigator Obligations & Regulatory Compliance Table
Sponsor Obligations
IRB/IEC Governance Provisions
Data Integrity & Record Retention
Intellectual Property & Publication Rights
Confidentiality & Non-Disclosure
Financial Terms & Payment Schedule
Indemnification & Insurance
Termination & Post-Study Obligations
Representations & Warranties
General Provisions & Signature Blocks

What it handles

Generates fully structured agreements covering recitals, definitions, and all regulatory obligations
Maps investigator duties to specific FDA regulations (21 CFR Parts 50, 56, 312, 812) and ICH GCP E6(R2)
Drafts comprehensive IP accountability, data integrity, and confidentiality provisions
Builds customizable financial terms with per-subject, per-procedure, or hybrid budget structures
Includes indemnification, insurance, termination, and post-study obligations
Produces built-in drafting checks for regulatory completeness and compliance

Required documents

Clinical Trial Protocol
The study protocol including protocol number, version, phase, design, investigational product details, indication, enrollment targets, and endpoints
.pdf, .docx
Party and Site Information
Legal names, addresses, and credentials for the sponsor, principal investigator, institution, and any CRO involvement, including governing state and contracting structure
.pdf, .docx, .xlsx
Budget and Financial Terms
Payment structure details including per-subject or per-procedure rates, fair market value documentation, and payment processing requirements
.pdf, .docx, .xlsx

Supporting documents

Institutional Templates or Policies
Any mandatory institutional provisions, indemnification policies, or template requirements that must be incorporated
.pdf, .docx
Delegation Log and Site Personnel List
List of sub-investigators, study coordinators, and other site personnel with qualifications and roles
.pdf, .docx, .xlsx
Prior Agreements or Amendments
Existing agreements or templates from prior studies that inform preferred terms or required provisions
.pdf, .docx

Why teams use it

Eliminate hours of manual drafting with AI that automatically maps obligations to FDA regulations and ICH GCP requirements

Reduce compliance risk with built-in regulatory checks covering 21 CFR Parts 50, 56, 312/812 and ICH E6(R2)

Standardize agreement quality across your clinical trial portfolio while maintaining flexibility for site-specific customization

Accelerate study startup timelines by generating ready-to-review agreements in minutes instead of days

Questions

What FDA regulations does the Investigator Agreement cover?

CaseMark's AI drafts agreements that address 21 CFR Parts 50 (informed consent), 56 (IRB), 312 (IND drugs/biologics), and 812 (IDE devices), as well as ICH GCP E6(R2) guidelines. Each investigator obligation is mapped to its specific regulatory basis.

Can the agreement handle different contracting structures?

Yes. CaseMark supports agreements where the PI contracts individually, where the institution is the primary party with the PI as signatory, or joint contracting arrangements. The AI adapts the agreement structure based on your specific setup.

Does it work for both drug and device clinical trials?

Absolutely. CaseMark generates Investigator Agreements for drug, biologic, and medical device studies, automatically referencing the appropriate regulatory framework (21 CFR 312 for drugs/biologics or 21 CFR 812 for devices).

How does CaseMark handle financial terms and fair market value?

CaseMark drafts financial provisions supporting per-subject, per-procedure, or hybrid payment structures. The AI incorporates fair market value considerations and generates payment schedules aligned with your budget inputs.

Can I customize the agreement for multi-center trials?

Yes. CaseMark adapts provisions for single-site and multi-center studies, adjusting publication rights, data ownership, oversight responsibilities, and coordination requirements accordingly.

How long does it take to generate a complete Investigator Agreement?

CaseMark typically generates a comprehensive, regulation-mapped Investigator Agreement in approximately 14 minutes. You can then review, customize, and export the final document immediately.