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Investigator Agreement For Device Studies

Investigator Agreement For Device Studies Template for England and Wales

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Key Requirements PROMPT example:

Investigator Agreement For Device Studies

"I need an Investigator Agreement For Device Studies for a multi-site clinical investigation of a Class III medical device in London and Manchester, with specific provisions for data sharing between institutions and additional safety monitoring requirements, to be implemented by March 2025."

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Document background
The Investigator Agreement For Device Studies is a crucial document used when conducting clinical investigations of medical devices in England and Wales. It establishes the legal framework between sponsors, investigators, and institutions, ensuring compliance with UK Medical Device Regulations, GDPR, and clinical research requirements. This agreement is essential for protecting all parties' interests, maintaining study integrity, and ensuring proper documentation of responsibilities in device investigations. It typically includes provisions for device handling, data collection, confidentiality, and regulatory compliance.
Suggested Sections

1. Parties: Identification of the sponsor, investigator, and institution

2. Background: Context of the study and purpose of the agreement

3. Definitions: Key terms used throughout the agreement

4. Study Conduct: Requirements for conducting the study in accordance with protocol

5. Investigator Obligations: Key responsibilities and commitments of the investigator

6. Device Handling: Procedures for device receipt, storage, use, and return

7. Data Collection and Reporting: Requirements for data management and submission

8. Confidentiality: Protection of confidential information

9. Intellectual Property: Ownership and rights to study-related IP

10. Term and Termination: Duration and termination provisions

Optional Sections

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

2. Subject Injury: Compensation provisions for study-related injuries - included when required by institutional policies

3. Insurance: Specific insurance requirements - included when additional coverage is needed beyond standard policies

Suggested Schedules

1. Schedule 1 - Study Protocol: Detailed protocol for the device study

2. Schedule 2 - Budget and Payment Schedule: Financial terms and payment milestones

3. Schedule 3 - Device Description: Technical specifications of the medical device

4. Schedule 4 - Data Protection Requirements: Specific data handling and protection procedures

5. Schedule 5 - Reporting Requirements: Templates and procedures for required reports

6. Schedule 6 - CV and Qualifications: Investigator's credentials and experience

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈË°æ | 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

UK Medical Devices Regulations: Primary legislation governing medical devices in the UK including the Medical Devices Regulations 2002 (as amended) and The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Clinical Research Regulations: Includes Medicines for Human Use (Clinical Trials) Regulations 2004, Good Clinical Practice (GCP) requirements, and ICH-GCP guidelines

Data Protection Legislation: UK General Data Protection Regulation (UK GDPR), Data Protection Act 2018, and Privacy and Electronic Communications Regulations (PECR)

Healthcare Regulations: Key healthcare legislation including Health and Social Care Act 2012, NHS Act 2006, and Human Rights Act 1998

Professional Standards: Guidelines and requirements from GMC (General Medical Council) and other healthcare professional regulatory bodies

Research Ethics Framework: Research Ethics Committee requirements and Health Research Authority (HRA) guidelines for conducting medical device studies

Contract Law: English Contract Law principles and common law principles relevant to commercial agreements in medical research

Employment Law: Employment Rights Act 1996 and Working Time Regulations 1998, particularly relevant to investigator status and obligations

Health and Safety Regulations: Health and Safety at Work Act 1974 and Control of Substances Hazardous to Health Regulations 2002

Intellectual Property Law: Patents Act 1977 and Copyright, Designs and Patents Act 1988, governing IP rights in medical device 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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