1. Parties: Identification of the parties including Sponsor, Institution, Principal Investigator, and any CRO if applicable
2. Background: Context of the clinical study, including brief description of the investigational product and purpose of the study
3. Definitions: Comprehensive definitions of terms used throughout the agreement
4. Scope of Work: Detailed description of the clinical study and each party's responsibilities
5. Compliance with Laws and Regulations: Obligations to comply with Nigerian laws, NAFDAC requirements, and international GCP guidelines
6. Study Protocol: Requirements for protocol adherence and amendment procedures
7. Patient Recruitment and Informed Consent: Procedures for participant recruitment, screening, and obtaining informed consent
8. Safety Reporting: Requirements for adverse event reporting and safety monitoring
9. Data Management and Protection: Procedures for data collection, storage, and protection under NDPR requirements
10. Quality Assurance and Monitoring: Requirements for study monitoring, audits, and quality control
11. Compensation and Payment Terms: Financial terms, payment schedule, and budget details
12. Confidentiality: Provisions for protecting confidential information of all parties
13. Intellectual Property: Rights and obligations regarding study-related IP and discoveries
14. Publication Rights: Terms governing the publication of study results
15. Term and Termination: Duration of agreement and conditions for termination
16. Insurance and Indemnification: Insurance requirements and allocation of risks between parties
17. Governing Law and Dispute Resolution: Nigerian law as governing law and dispute resolution procedures
18. General Provisions: Standard boilerplate provisions including notices, assignment, and amendments
