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Investigator Agreement

Draft Clinical Trial Investigator Agreements in Minutes

14 minutes with CaseMark

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Investigator Agreement

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Investigator Agreement

Overview

CaseMark's Investigator Agreement skill drafts comprehensive, FDA-compliant contracts governing the sponsor–principal investigator relationship for clinical research. It covers the full spectrum of regulatory, financial, and operational provisions required for drug, biologic, and device studies, producing a ready-to-review agreement in minutes rather than the hours or days typically required for manual drafting.

Drafting Investigator Agreements for FDA-regulated clinical trials is one of the most complex contracting tasks in life sciences law. Each agreement must weave together obligations from multiple regulatory frameworks—21 CFR Parts 50, 56, 312, and 812, plus ICH GCP E6(R2)—while addressing site-specific financial terms, institutional policies, and study design variables. Manual drafting is time-intensive, error-prone, and creates bottlenecks that delay trial activation.

CaseMark's AI-powered Investigator Agreement skill automates the drafting process by analyzing your protocol, party details, and financial terms to generate a comprehensive, regulation-mapped agreement. Every investigator obligation is tied to its specific regulatory citation, financial provisions reflect fair market value standards, and the output adapts to your exact contracting structure—delivering a polished draft ready for review and negotiation.

How it works

  1. 1. Upload your clinical trial protocol, party details, and budget information

  2. 2. AI analyzes regulatory requirements and drafts a comprehensive Investigator Agreement

  3. 3. Review and customize provisions for your specific study type, phase, and institutional structure

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

What you get

  • Recitals & Definitions

  • Investigator Obligations & Regulatory Compliance Table

  • Sponsor Obligations & Oversight

  • IRB Governance & Informed Consent Provisions

  • Data Integrity, Records & Reporting Requirements

  • Investigational Product Accountability

  • Confidentiality & Publication Rights

  • Intellectual Property Ownership

  • Financial Terms & Payment Schedule

  • Indemnification & Insurance

  • Term, Termination & Post-Study Obligations

  • Signature Blocks & Exhibits

What it handles

  • Comprehensive regulatory compliance mapping across 21 CFR Parts 50, 56, 312, and 812

  • ICH GCP E6(R2) obligation tables with delegation and oversight provisions

  • Customizable financial terms with fair market value budget structures

  • IRB governance, informed consent, and adverse event reporting clauses

  • IP accountability, data integrity, and publication rights provisions

  • Indemnification, insurance, and termination frameworks tailored to study type

Required documents

  • Clinical Trial Protocol

    The study protocol including phase, design, investigational product, indication, enrollment targets, and endpoints

    .pdf, .docx

  • Party and Site Details

    Legal names, PI credentials, institutional information, governing state, CRO involvement, and contracting structure

    .pdf, .docx, .xlsx

  • Budget and Financial Terms

    Payment structure (per-subject, per-procedure, or hybrid), fair market value documentation, and payment processing requirements

    .pdf, .docx, .xlsx

Supporting documents

  • Prior Agreements or Templates

    Existing institutional templates, mandatory provisions, or indemnification policies to incorporate

    .pdf, .docx

  • Site Personnel List

    Sub-investigators, study coordinators, and specialists who will be involved in the trial

    .pdf, .docx, .xlsx

  • Institutional Policies

    Relevant institutional policies on IP ownership, publication, insurance, or conflict of interest

    .pdf, .docx

Why teams use it

Ensures comprehensive regulatory compliance with automated mapping to 21 CFR and ICH GCP requirements

Reduces drafting time from hours or days to minutes while maintaining legal precision

Adapts seamlessly to different sponsor types, contracting structures, and study phases

Produces consistent, high-quality agreements with built-in drafting checks and placeholder tracking

Questions

What types of clinical trials does this Investigator Agreement cover?

CaseMark's Investigator Agreement skill supports drug, biologic, and device studies across all phases. It adapts to IND (21 CFR 312) and IDE (21 CFR 812) regulatory frameworks, covering single-site and multi-center trial structures.

How does the agreement handle FDA regulatory compliance?

CaseMark automatically maps investigator obligations to specific regulatory citations including 21 CFR Parts 50, 56, 312, and 812, as well as ICH GCP E6(R2) requirements. Each obligation is tied to its regulatory basis and core requirement for full traceability.

Can I customize the financial and indemnification terms?

Absolutely. CaseMark generates customizable financial provisions supporting per-subject, per-procedure, or hybrid payment models based on fair market value. Indemnification clauses are tailored to your sponsor type and institutional policies.

Does the agreement address different contracting structures?

Yes. CaseMark adapts the agreement for PI-individual contracts, institution-as-primary-party with PI signatory arrangements, or joint contracting structures. It also accommodates pharma, biotech, device, academic, and government sponsor types.

How does CaseMark handle IRB and informed consent provisions?

CaseMark drafts comprehensive IRB governance clauses covering initial and continuing review, protocol amendments, and adverse event reporting. Informed consent provisions align with 21 CFR Part 50 requirements and ICH GCP standards.

Can I use this for multi-center clinical trials?

Yes. CaseMark addresses multi-center considerations including publication rights, data ownership, central vs. local oversight structures, and coordination obligations that are critical for multi-site study agreements.

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