Investigator Agreement Template for Nigeria

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Key Requirements PROMPT example:

Investigator Agreement

"I need an Investigator Agreement under Nigerian law for a Phase II clinical trial of a new diabetes medication, where our pharmaceutical company will engage three principal investigators across different teaching hospitals in Lagos, with the study scheduled to commence in March 2025."

Document background
The Investigator Agreement is a crucial document used in clinical research settings in Nigeria when engaging medical professionals to conduct clinical trials or medical research studies. This agreement establishes the legal framework for the relationship between the research sponsor or institution and the investigator, ensuring compliance with Nigerian regulations including the National Health Act 2014, NAFDAC requirements, and NHREC guidelines. It covers essential aspects such as protocol adherence, subject safety, data protection, reporting obligations, and intellectual property rights. The agreement is particularly important in the Nigerian context due to specific local regulatory requirements and the need to ensure proper oversight of medical research activities while protecting both study subjects and research integrity.
Suggested Sections

1. Parties: Identification of the research institution/sponsor and the investigator

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

3. Definitions: Key terms used throughout the agreement including Study, Protocol, Study Site, Study Subject, etc.

4. Scope of Services: Detailed description of the investigator's responsibilities and services to be provided

5. Compliance with Laws and Regulations: Obligations to comply with Nigerian laws, regulations, and guidelines including NHREC and NAFDAC requirements

6. Protocol Adherence: Requirements for following the study protocol and making any protocol amendments

7. Study Site and Personnel: Requirements for study site facilities and qualification of study personnel

8. Subject Recruitment and Informed Consent: Procedures for subject recruitment, screening, and obtaining informed consent

9. Data Collection and Reporting: Requirements for data collection, recording, and reporting, including adverse events

10. Confidentiality: Obligations regarding confidential information and data protection

11. Intellectual Property: Rights and obligations regarding study results, inventions, and publications

12. Payment Terms: Compensation structure, payment schedule, and related financial terms

13. Term and Termination: Duration of agreement and circumstances for termination

14. Insurance and Indemnification: Insurance requirements and indemnification obligations

15. General Provisions: Standard contractual provisions including notices, assignment, governing law, etc.

Optional Sections

1. Study Drug Management: Include when the study involves investigational products, covering storage, handling, and accountability

2. Equipment and Supplies: Include when sponsor provides specific equipment or supplies for the study

3. Publication Rights: Include detailed publication terms when academic institutions are involved

4. Sub-investigator Obligations: Include when multiple investigators are involved in the study

5. Biological Samples: Include when study involves collection and handling of biological samples

6. Quality Assurance: Include detailed quality control measures for complex studies

7. Data Protection Officer: Include when processing large amounts of personal data requiring DPO appointment under NDPR

Suggested Schedules

1. Schedule 1 - Protocol: The approved study protocol including any amendments

2. Schedule 2 - Budget and Payment Schedule: Detailed breakdown of payment terms, amounts, and timing

3. Schedule 3 - Timeline: Study timeline including key milestones and deliverables

4. Schedule 4 - Required Documentation: List of required regulatory and ethical approvals

5. Schedule 5 - Personnel and Responsibilities: List of key study personnel and their specific responsibilities

6. Schedule 6 - Data Protection Requirements: Specific data protection and privacy requirements under NDPR

7. Schedule 7 - Equipment Inventory: List of equipment provided by sponsor (if applicable)

8. Appendix A - Form of Informed Consent: Template informed consent form

9. Appendix B - Quality Assurance Requirements: Detailed quality control and assurance procedures

Authors

Alex Denne

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

Relevant legal definitions
Clauses
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Academic Research

Healthcare Technology

Life Sciences

Relevant Teams

Legal

Clinical Operations

Medical Affairs

Research Administration

Compliance

Regulatory Affairs

Clinical Research

Contracts Administration

Ethics Committee

Data Protection

Relevant Roles

Principal Investigator

Clinical Research Director

Medical Director

Research Coordinator

Legal Counsel

Compliance Officer

Clinical Operations Manager

Research Ethics Officer

Medical Affairs Manager

Contract Manager

Chief Medical Officer

Research Administration Director

Data Protection Officer

Clinical Trial Manager

Industries
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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