Clinical Trial Investigator Agreement

Draft Investigator Agreements in Minutes, Not Hours

14 minutes with CaseMark

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14 minutes with CaseMark

What you'll need

Study Protocol
Investigator's Brochure or Device Manual
Budget and Payment Schedule

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

Workflow

Overview

CaseMark's Clinical Trial Investigator Agreement skill uses AI to draft comprehensive, FDA-compliant agreements between sponsors or CROs and principal investigators or institutions for regulated drug, biologic, and device studies. It automates the complex process of weaving together regulatory obligations from 21 CFR Parts 50, 56, 312, and 812, ICH GCP E6(R2), HIPAA, and Anti-Kickback Statute requirements into a single, cohesive contract with integrated exhibits and compliance verification.

Drafting clinical trial investigator agreements is one of the most time-consuming bottlenecks in study startup. Each agreement must reconcile a dense web of FDA regulations, ICH GCP guidelines, HIPAA privacy rules, IRB requirements, financial compliance mandates, and institution-specific policies—often requiring days of attorney time and multiple revision cycles that delay enrollment.

CaseMark automates the entire drafting process by intelligently mapping your protocol details, site information, and budget terms against the full regulatory landscape. The AI generates a comprehensive, compliance-verified agreement with all required sections and exhibits, dramatically reducing drafting time while ensuring no critical obligation is overlooked.

How it works

1. Upload your protocol documents, investigator brochure, site details, and budget terms
2. AI identifies the regulatory track (drug/biologic vs. device) and applies all applicable FDA, GCP, and HIPAA requirements
3. Review and customize the fully drafted agreement with integrated compliance checks
4. Export the finalized investigator agreement and exhibits in your preferred format (DOCX, PDF)

What you get

Parties and Definitions
Study Description and Protocol Incorporation
Regulatory Obligations (FDA, IRB, GCP, HIPAA)
Investigator Responsibilities and Delegation of Duties
Informed Consent and Vulnerable Population Protections
Budget, Payment, and Financial Disclosure Provisions
Confidentiality, Data Ownership, and Publication Rights
Intellectual Property and Sample Handling
Indemnification, Insurance, and Liability
Audit Access and Monitoring Rights
Term, Termination, and Survival Provisions
Exhibits (Protocol, Budget, Delegation Log, Insurance Certificates)
Compliance Verification Checklist

What it handles

Automatic regulatory track selection for drug/biologic (21 CFR 312) vs. device (21 CFR 812) studies
Built-in compliance checks for ICH GCP E6(R2), HIPAA, IRB, and financial disclosure requirements
FMV/Anti-Kickback Statute payment compliance with per-subject, per-visit, and milestone models
Comprehensive IP ownership, publication rights, and data integrity provisions
Indemnification and insurance clauses tailored to academic, public, and private institutions
Auto-generated exhibits including protocol references, budget schedules, and delegation logs

Required documents

Study Protocol
The clinical trial protocol including protocol number, title, version date, phase, endpoints, and enrollment target
.pdf, .docx
Investigator's Brochure or Device Manual
The investigator's brochure (for drugs/biologics) or device manual (for devices) with investigational product handling requirements
.pdf, .docx
Budget and Payment Schedule
The proposed budget model, payment schedule, per-subject/per-visit rates, milestones, and invoicing rules
.pdf, .docx, .xlsx

Supporting documents

Institutional Template or Required Language
Any institution-mandated contract template, required clauses, or policy documents that must be incorporated
.pdf, .docx
IRB Approval and Consent Forms
IRB approval letters, informed consent/assent forms, and recruitment materials for reference
.pdf, .docx
Insurance Certificates
Current certificates of insurance for sponsor and/or institution to inform indemnification and liability provisions
.pdf
PI Credentials and Study Team Roster
Principal investigator CV, medical license, sub-investigator qualifications, and study team delegation details
.pdf, .docx

Why teams use it

Reduce agreement drafting time from days to minutes while maintaining full regulatory compliance across FDA, GCP, HIPAA, and financial disclosure frameworks

Eliminate the risk of missing critical regulatory provisions with automated compliance checks against 21 CFR Parts 50, 56, 312/812, and ICH GCP E6(R2)

Standardize investigator agreements across your clinical trial portfolio while preserving flexibility for site-specific institutional requirements

Accelerate study startup timelines by generating execution-ready drafts with all exhibits, schedules, and cross-references built in

Questions

Does this handle both drug/biologic and medical device clinical trials?

Yes. CaseMark automatically detects whether your study falls under 21 CFR Part 312 (drugs/biologics with IND obligations) or 21 CFR Part 812 (devices with IDE obligations) and tailors every regulatory provision accordingly.

How does CaseMark ensure payment terms comply with Anti-Kickback Statute and Fair Market Value requirements?

CaseMark structures payment provisions around recognized FMV and AKS compliance frameworks, including per-subject, per-visit, and milestone-based models. It flags payment structures that may raise regulatory concerns and incorporates 21 CFR Part 54 financial disclosure requirements.

Can I customize the agreement for academic medical centers or public institutions?

Absolutely. CaseMark accommodates institutional template language, sovereign immunity constraints, academic indemnity limitations, and public entity insurance requirements. You can input site-specific policies during the drafting process.

Does the output include all required exhibits and attachments?

Yes. CaseMark generates the core agreement along with exhibits incorporated by reference, including protocol summaries, budget schedules, delegation of authority logs, and insurance certificate placeholders—all cross-referenced within the agreement body.

How does CaseMark handle IRB and informed consent requirements?

CaseMark drafts provisions covering 21 CFR Part 50 informed consent obligations, legally authorized representative and assent requirements, 21 CFR Part 56 IRB oversight, and 45 CFR 46 Subparts B, C, and D protections for vulnerable populations.

Is the generated agreement ready to execute as-is?

CaseMark produces a comprehensive, compliance-checked draft that substantially reduces attorney drafting time. However, we recommend legal review to confirm alignment with your specific institutional policies, state law requirements, and negotiated business terms before execution.