1. Parties: Identification of contracting parties including sponsor/CRO and the research site/institution
2. Background: Context of the agreement, brief description of the clinical trial, and purpose of the agreement
3. Definitions: Detailed definitions of key terms used throughout the agreement
4. Scope of Services: Detailed description of the clinical trial and services to be provided by the site
5. Principal Investigator Obligations: Specific responsibilities and commitments of the principal investigator
6. Institution Obligations: Responsibilities and commitments of the research institution
7. Sponsor Obligations: Responsibilities and commitments of the sponsor/CRO
8. Compliance: Requirements for regulatory compliance, including GCP, applicable laws, and ethical guidelines
9. Patient Recruitment and Informed Consent: Procedures and requirements for patient recruitment and obtaining informed consent
10. Documentation and Record Keeping: Requirements for maintaining trial records, source documents, and other documentation
11. Confidentiality: Provisions for protecting confidential information of all parties and trial participants
12. Intellectual Property: Rights and obligations regarding IP generated during the trial
13. Data Protection and Privacy: Compliance with data protection laws and privacy requirements
14. Publication Rights: Terms governing the publication of trial results and academic rights
15. Payment Terms: Financial terms, payment schedule, and related conditions
16. Term and Termination: Duration of agreement and conditions for termination
17. Insurance and Indemnification: Insurance requirements and indemnification provisions
18. Dispute Resolution: Procedures for resolving disputes between parties
19. Governing Law: Applicable law and jurisdiction
20. General Provisions: Standard boilerplate clauses including notices, amendments, assignment, etc.
