Investigator Agreement Template for Canada

The Investigator Agreement serves as the cornerstone document in clinical research, establishing the legal and operational framework between sponsors and investigators conducting clinical trials in Canada. This document is essential when a pharmaceutical company, research organization, or medical institution initiates a clinical study and needs to engage a qualified investigator to conduct the research. It ensures compliance with Canadian regulatory requirements, including Health Canada guidelines, ICH-GCP standards, and provincial healthcare regulations. The agreement covers critical aspects such as study protocol implementation, patient safety, data management, regulatory compliance, financial terms, and intellectual property rights. It's particularly important for maintaining regulatory compliance and protecting all parties' interests in the complex landscape of clinical research.

1. Parties: Identification of the sponsor/institution and investigator, including full legal names and addresses

2. Background: Context of the clinical trial, study identification, and purpose of the agreement

3. Definitions: Definitions of key terms used throughout the agreement, including Study, Protocol, Study Drug, Study Data, etc.

4. Scope of Work: Detailed description of investigator's responsibilities and conduct of the study

5. Compliance: Obligations regarding regulatory compliance, ICH-GCP guidelines, and protocol adherence

6. Study Team and Facilities: Requirements for study personnel qualifications and facility standards

7. Patient Recruitment and Informed Consent: Procedures for subject recruitment, screening, and obtaining informed consent

8. Data Collection and Reporting: Requirements for data collection, recording, and submission of study data

9. Confidentiality: Provisions for protecting confidential information and study data

10. Safety Reporting: Obligations for adverse event reporting and safety monitoring

11. Financial Provisions: Payment terms, budget details, and financial obligations

12. Publication Rights: Terms governing publication of study results and academic freedom

13. Intellectual Property: Ownership and rights to inventions, discoveries, and study results

14. Term and Termination: Duration of agreement and conditions for termination

15. General Provisions: Standard legal provisions including governing law, dispute resolution, and entire agreement