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.
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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."
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
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
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
Relevant legal definitions
Agreement
Adverse Event
Applicable Laws
Background IP
Case Report Form (CRF)
Clinical Investigation
Clinical Investigation Plan
Confidential Information
Data Protection Laws
Device
Effective Date
Ethics Committee
Foreground IP
Good Clinical Practice
Institution
Investigation Site
Investigator
Medical Device Regulations
Monitor
Party/Parties
Personal Data
Principal Investigator
Protocol
Regulatory Authority
Research Staff
Serious Adverse Event
Source Documents
Sponsor
Study
Study Completion Date
Study Data
Study Subject
Study Team
Sub-Investigator
Term
Territory
Trial Master File
Adverse Event
Applicable Laws
Background IP
Case Report Form (CRF)
Clinical Investigation
Clinical Investigation Plan
Confidential Information
Data Protection Laws
Device
Effective Date
Ethics Committee
Foreground IP
Good Clinical Practice
Institution
Investigation Site
Investigator
Medical Device Regulations
Monitor
Party/Parties
Personal Data
Principal Investigator
Protocol
Regulatory Authority
Research Staff
Serious Adverse Event
Source Documents
Sponsor
Study
Study Completion Date
Study Data
Study Subject
Study Team
Sub-Investigator
Term
Territory
Trial Master File
Clauses
Obligations of Principal Investigator
Study Conduct
Protocol Compliance
Device Management
Patient Safety
Adverse Event Reporting
Record Keeping
Data Protection
Confidentiality
Intellectual Property
Publication Rights
Regulatory Compliance
Ethics Committee Approval
Financial Arrangements
Compensation
Insurance
Indemnification
Term and Termination
Study Suspension
Force Majeure
Assignment
Governing Law
Dispute Resolution
Monitoring and Auditing
Quality Assurance
Documentation Requirements
Device Training
Subject Recruitment
Informed Consent
Study Reporting
Warranties
Notices
Entire Agreement
Amendments
Severability
Survival
Study Conduct
Protocol Compliance
Device Management
Patient Safety
Adverse Event Reporting
Record Keeping
Data Protection
Confidentiality
Intellectual Property
Publication Rights
Regulatory Compliance
Ethics Committee Approval
Financial Arrangements
Compensation
Insurance
Indemnification
Term and Termination
Study Suspension
Force Majeure
Assignment
Governing Law
Dispute Resolution
Monitoring and Auditing
Quality Assurance
Documentation Requirements
Device Training
Subject Recruitment
Informed Consent
Study Reporting
Warranties
Notices
Entire Agreement
Amendments
Severability
Survival
Relevant Industries
Relevant Teams
Relevant Roles
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