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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."
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.
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
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
Applicable Law
Approval
Clinical Trial
Confidential Information
Contract Research Organization (CRO)
Data Protection Laws
Effective Date
Ethics Committee
Good Clinical Practice (GCP)
Institution
Intellectual Property Rights
Investigational Product
Investigator
Investigator Site
NAFDAC
NHREC
Patient Data
Personal Data
Principal Investigator
Protocol
Regulatory Authority
Research Staff
Serious Adverse Event
Sponsor
Study
Study Completion
Study Data
Study Documents
Study Personnel
Study Site
Study Subject
Sub-Investigator
Subject Information
Term
Trial Master File
Informed Consent Form
Study Timeline
Study Budget
Quality Standards
Research Results
Background IP
Foreground IP
Study Materials
Compliance Requirements
Documentation
Medical Records
Protocol Deviation
Safety Reporting
Study Procedures
Definitions
Scope of Services
Compliance
Study Protocol
Research Standards
Regulatory Obligations
Site Management
Personnel Requirements
Subject Recruitment
Informed Consent
Data Collection
Record Keeping
Confidentiality
Data Protection
Intellectual Property
Publication Rights
Payment Terms
Compensation
Quality Assurance
Safety Reporting
Insurance
Indemnification
Term
Termination
Force Majeure
Assignment
Subcontracting
Audit Rights
Representations and Warranties
Dispute Resolution
Governing Law
Notices
Entire Agreement
Amendments
Severability
Waiver
Counterparts
Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Clinical Research
Academic Research
Healthcare Technology
Life Sciences
Legal
Clinical Operations
Medical Affairs
Research Administration
Compliance
Regulatory Affairs
Clinical Research
Contracts Administration
Ethics Committee
Data Protection
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
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