1. Parties: Identification of all contracting parties including sponsor, institution, principal investigator, and any relevant third parties
2. Background: Context of the clinical trial, including brief description of the study drug/device and purpose of the trial
3. Definitions: Detailed definitions of terms used throughout the agreement
4. Scope of Trial: Detailed description of the clinical trial, including protocol reference and compliance requirements
5. Regulatory Compliance: Obligations regarding compliance with laws, regulations, and ethical requirements
6. Roles and Responsibilities: Detailed obligations of each party in conducting the trial
7. Trial Governance: Management structure, decision-making processes, and oversight procedures
8. Patient Recruitment and Consent: Procedures for participant recruitment, informed consent, and patient rights
9. Drug/Device Management: Handling, storage, and accountability of trial materials
10. Data Management and Protection: Procedures for data collection, processing, and protection in compliance with GDPR
11. Safety Reporting: Procedures for adverse event reporting and safety monitoring
12. Financial Provisions: Payment terms, costs, and financial responsibilities
13. Insurance and Indemnification: Insurance requirements and indemnification provisions
14. Intellectual Property: Ownership and rights to trial data, results, and inventions
15. Confidentiality: Protection of confidential information and trade secrets
16. Publication Rights: Terms for publishing trial results and academic rights
17. Term and Termination: Duration of agreement and termination provisions
18. General Provisions: Standard legal provisions including governing law, dispute resolution, and entire agreement
