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Investigator Agreement

Investigator Agreement Template for England and Wales

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Key Requirements PROMPT example:

Investigator Agreement

"I need an Investigator Agreement for a Phase II clinical trial of a new cancer drug, where our pharmaceutical company will engage three principal investigators across different NHS hospitals in London, with the trial scheduled to begin in March 2025."

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Document background
The Investigator Agreement serves as the cornerstone document for clinical trials in England and Wales, establishing the legal framework between sponsors and investigators. This contract type is essential when initiating clinical research, ensuring compliance with UK Clinical Trials Regulations, GCP guidelines, and data protection laws. It details the investigator's obligations, study protocols, patient safety measures, data handling requirements, and compensation terms. The agreement is particularly crucial for maintaining regulatory compliance and protecting all parties' interests throughout the clinical trial process.
Suggested Sections

1. Parties: Details of the sponsor/CRO and investigator

2. Background: Context of the clinical trial and purpose of the agreement

3. Definitions: Key terms used throughout the agreement

4. Services: Detailed description of investigator's responsibilities

5. Study Protocol Compliance: Requirements for adherence to study protocol

6. Confidentiality: Handling of confidential information

7. Data Protection: Compliance with data protection laws

8. Payment Terms: Compensation and payment schedule

9. Term and Termination: Duration and termination provisions

Optional Sections

1. Publication Rights: Terms for publishing study results - used when academic institutions are involved

2. Equipment Provision: Terms for supplied equipment - used when sponsor provides specific equipment

3. Sub-investigator Terms: Requirements for additional investigators - used when multiple investigators are involved

Suggested Schedules

1. Payment Schedule: Detailed breakdown of payments and timing

2. Protocol Summary: Key elements of the study protocol

3. Study Timeline: Key milestones and deadlines

4. Data Protection Requirements: Specific data handling procedures

5. Required Documentation: List of necessary certifications and documents

Authors

Alex Denne

Head of Growth (Open Source Law) @ ¶¶Òõ¶ÌÊÓƵ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co
Relevant legal definitions







































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Industries

Clinical Trials Regulations: The Medicines for Human Use (Clinical Trials) Regulations 2004, UK Clinical Trials Regulations (post-Brexit), and Human Medicines Regulations 2012 governing the conduct of clinical trials

Data Protection Laws: UK General Data Protection Regulation (UK GDPR), Data Protection Act 2018, and Privacy and Electronic Communications Regulations (PECR) for handling personal and research data

Healthcare Research Governance: Health Research Authority (HRA) requirements, NHS Research Governance Framework, Good Clinical Practice (GCP) guidelines, and ICH guidelines for research conduct

Professional Standards Regulations: GMC guidelines, Medical Act 1983, and various healthcare professional regulatory bodies' requirements for medical professionals

Health and Safety Legislation: Health and Safety at Work Act 1974 and Control of Substances Hazardous to Health Regulations 2002 for workplace safety

Contract Law: English common law principles, Unfair Contract Terms Act 1977, and Consumer Rights Act 2015 governing contractual relationships

Employment Law: Employment Rights Act 1996 and Working Time Regulations 1998 for employment-related aspects of the investigation

Intellectual Property Law: Patents Act 1977, Copyright, Designs and Patents Act 1988, and Trade Marks Act 1994 for protecting research innovations and data

Ethics and Research Laws: Human Tissue Act 2004, Mental Capacity Act 2005, and Research Ethics Committee requirements for ethical research conduct

Insurance and Liability Requirements: Professional indemnity requirements and clinical negligence schemes for protecting all parties involved in the research

Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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