Drafting investigator agreements for clinical trials is a complex, time-intensive process requiring deep knowledge of GCP regulations, FDA requirements, and IRB protocols. Attorneys spend hours ensuring every regulatory obligation is properly documented while coordinating details between sponsors, investigators, and institutions. Manual drafting increases the risk of missing critical compliance provisions that could jeopardize the entire trial.
Clinical trial investigator agreements require intricate knowledge of FDA regulations, ICH-GCP standards, institutional policies, and complex liability provisions. Manually drafting these agreements takes 12+ hours of attorney time, coordinating multiple regulatory frameworks while balancing sponsor needs against institutional requirements and investigator academic freedom.
CaseMark automates investigator agreement drafting by analyzing your protocol, institutional requirements, and regulatory framework to generate comprehensive, FDA-compliant contracts in minutes. Our AI incorporates 21 CFR compliance, ICH-GCP requirements, fair market value provisions, and institution-specific policies into ready-to-negotiate agreements.
This workflow is applicable across multiple practice areas and use cases
Healthcare attorneys at academic medical centers and hospitals regularly negotiate investigator agreements for clinical trials, requiring compliance with both FDA regulations and institutional healthcare policies.
Clinical trial agreements are core healthcare law documents that intersect with patient care, medical research, and institutional compliance. Healthcare lawyers frequently draft and review these agreements for hospital systems and medical institutions.
Investigator agreements define the employment or consulting relationship between sponsors and principal investigators, including compensation, duties, confidentiality, and publication rights.
These agreements establish contractual relationships with investigators who may be employees or independent contractors, requiring careful drafting of compensation terms, obligations, and intellectual property provisions typical of employment/consulting agreements.
Clinical trial investigator agreements contain critical IP provisions regarding data ownership, publication rights, and licensing of study results between sponsors and research institutions.
These agreements routinely address intellectual property ownership, data rights, and publication restrictions that are central to IP licensing practice, particularly regarding research data and potential patent rights arising from clinical trials.
In-house corporate counsel at pharmaceutical, biotech, and medical device companies use investigator agreements as essential commercial contracts for product development and regulatory approval processes.
Corporate legal departments at life sciences companies regularly manage portfolios of investigator agreements as part of their product development strategy, requiring standardized contract management and compliance oversight.
The agreement incorporates comprehensive FDA compliance under 21 CFR Parts 50 (informed consent), 56 (IRB requirements), and 312 (IND regulations for drugs/biologics) or Part 812 (IDE for devices). It also implements ICH Good Clinical Practice E6(R2) standards, HIPAA privacy protections, financial disclosure requirements under 21 CFR Part 54, and applicable state laws governing human subjects research. All regulatory obligations are translated into specific, enforceable contractual duties.
CaseMark analyzes any institutional templates or previous agreements you provide to identify mandatory provisions, non-negotiable policies on indemnification and liability, institutional payment processing requirements, and unique compliance obligations. The system adapts the agreement structure for academic medical centers (which typically prohibit indemnifying sponsors), community hospitals, or private research sites, ensuring compatibility with institutional policies while protecting sponsor interests.
The agreement includes comprehensive confidentiality provisions protecting the protocol, investigator's brochure, study data, and proprietary information, with appropriate exceptions for IRB submissions and regulatory disclosures. Data ownership clauses establish the sponsor's exclusive rights to all study data, results, and discoveries. Publication provisions balance the investigator's academic freedom with the sponsor's rights to review manuscripts, request confidential information removal, and delay publication to file patent applications.
The agreement includes detailed budget exhibits itemizing compensation for each protocol activity (screening, visits, procedures, adverse event management) with amounts based on time, effort, complexity, and market rates. All payments include representations that they constitute fair market value for services provided and are not intended to induce prescribing or purchasing. The structure ensures compliance with the Anti-Kickback Statute, state laws, and institutional policies, with appropriate financial disclosure requirements under 21 CFR Part 54.
The agreement provides comprehensive termination provisions including the sponsor's right to terminate for convenience with 30-60 days' notice or immediately for cause (protocol violations, regulatory non-compliance, loss of IRB approval). It details wind-down obligations including subject notification, completion of enrolled subjects when feasible, final data submission, investigational product return, and confidential information destruction. Payment provisions ensure compensation for completed work and reasonable wind-down costs while protecting enrolled subjects' safety and welfare.
The agreement includes sophisticated indemnification provisions where the sponsor indemnifies for product-related claims (design defects, manufacturing issues, product liability) while the investigator or institution covers claims arising from negligence, protocol deviations, or regulatory non-compliance. For academic institutions that cannot provide indemnification, the agreement relies on professional liability insurance. Insurance requirements specify minimum coverage amounts, and detailed claim procedures ensure proper coordination between parties and their insurers.