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Clinical Trial Investigator Agreement

Draft Investigator Agreements in Minutes, Not Hours

14 minutes with CaseMark

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Clinical Trial Investigator Agreement

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Workflow

Clinical Trial Investigator Agreement

Overview

CaseMark's Clinical Trial Investigator Agreement skill drafts comprehensive, FDA-compliant agreements between sponsors or CROs and principal investigators or institutions for regulated drug, biologic, and device studies. The AI handles the full complexity of clinical trial contracting—from regulatory flow-down obligations and IRB requirements to payment compliance, publication rights, and indemnification—producing a ready-to-review agreement in minutes.

Drafting clinical trial investigator agreements is one of the most time-consuming bottlenecks in study startup. Each agreement must weave together complex FDA regulations, ICH GCP standards, HIPAA requirements, institutional policies, and financial compliance rules—often requiring multiple rounds of legal review and negotiation that delay enrollment by weeks or months.

CaseMark automates the drafting of investigator agreements by intelligently assembling regulatory-compliant provisions based on your study's specific parameters. The AI identifies the correct regulatory track, incorporates site-specific policies and institutional constraints, and produces a comprehensive agreement with built-in compliance verification—dramatically accelerating study startup while reducing legal risk.

How it works

  1. 1. Upload your protocol documents, sponsor/site details, and budget information

  2. 2. AI identifies the regulatory track (drug/biologic vs. device) and drafts a fully structured agreement

  3. 3. Review the agreement with built-in compliance checks against FDA, GCP, HIPAA, and IRB requirements

  4. 4. Export the finalized investigator agreement in your preferred format (DOCX, PDF)

What you get

  • Parties and Definitions

  • Study Description and Protocol Reference

  • Regulatory Obligations (FDA, IRB, GCP)

  • Informed Consent and Vulnerable Population Provisions

  • Financial Disclosure and Payment Terms

  • Data Ownership, Publication Rights, and IP

  • Confidentiality and HIPAA Compliance

  • Indemnification and Insurance

  • Audit Access and Record Retention

  • Termination and Survival

  • Exhibits and Attachments

  • 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 FDA, ICH GCP E6(R2), HIPAA, and IRB requirements

  • FMV/Anti-Kickback Statute payment compliance and budget structuring

  • Publication rights, IP ownership, and data integrity provisions

  • Indemnification, insurance, and audit access clauses tailored to institutional constraints

  • Exhibit generation with protocol, budget, and regulatory document references

Required documents

  • Study Protocol

    The clinical trial protocol including protocol number, title, version date, phase, endpoints, and enrollment target

    .pdf, .docx

  • Sponsor and Site Information

    Details on sponsor identity, CRO involvement, site legal name, PI credentials, sub-investigators, and contracting structure

    .pdf, .docx, .txt

  • Budget and Payment Schedule

    Per-subject, per-visit, or milestone-based payment model with invoicing rules and financial terms

    .pdf, .docx, .xlsx

Supporting documents

  • Investigator's Brochure or Device Manual

    Product-specific safety and handling information for the investigational product

    .pdf, .docx

  • Institutional Template or Required Language

    Any mandatory contract language or template provisions required by the institution

    .pdf, .docx

  • IRB Approval and Consent Forms

    IRB details, approved informed consent/assent forms, and recruitment materials

    .pdf, .docx

  • Insurance and Indemnity Documentation

    Insurance certificates, indemnity constraints, or coverage limitations for the site or institution

    .pdf, .docx

Why teams use it

Reduce agreement drafting time from days to minutes while maintaining regulatory rigor across FDA, GCP, HIPAA, and IRB requirements

Minimize compliance risk with automated checks against 21 CFR Parts 50, 54, 56, 312/812, ICH GCP E6(R2), and Anti-Kickback Statute standards

Ensure consistency across multi-site trials with standardized yet customizable agreement templates

Accelerate study startup timelines by eliminating bottlenecks in investigator agreement negotiation and execution

Questions

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

Yes. CaseMark automatically identifies 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 clause accordingly.

How does CaseMark ensure Anti-Kickback Statute and Fair Market Value compliance?

CaseMark structures payment provisions to align with FMV principles and AKS safe harbors. The AI flags payment models that may raise compliance concerns and ensures financial disclosure obligations under 21 CFR Part 54 are addressed.

Can I customize the agreement for academic institutions or public entities?

Absolutely. CaseMark accommodates institutional policies, academic indemnity limitations, public entity constraints, and required template language. You can specify these details during the intake process.

Does the agreement address publication rights and intellectual property?

Yes. CaseMark drafts detailed publication rights provisions including review periods, delay rights for patent filings, and IP ownership clauses that balance sponsor and investigator interests based on your specified posture.

How does CaseMark handle HIPAA and state privacy requirements?

CaseMark incorporates HIPAA-compliant data handling provisions and flags applicable state privacy law considerations. The agreement includes appropriate authorization language and data use limitations for protected health information.

What compliance verification does CaseMark perform?

CaseMark runs the drafted agreement against a comprehensive checklist covering 21 CFR Parts 50, 54, 56, 312/812, ICH GCP E6(R2), HIPAA, IRB requirements, and financial compliance standards, highlighting any gaps before finalization.

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