Investigator Agreement Template for India

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Key Requirements PROMPT example:

Investigator Agreement

"I need an Investigator Agreement for a Phase III pharmaceutical trial in India, to be conducted across five hospital sites in Mumbai and Delhi, starting March 2025, with specific provisions for handling biological samples and data sharing between sites."

Document background
The Investigator Agreement serves as a crucial document in clinical research operations within India, establishing the legal and operational framework for conducting clinical trials. This agreement is required whenever a pharmaceutical company, biotechnology firm, or other sponsor engages a medical professional to conduct clinical research studies in India. The document must comply with the Drugs and Clinical Trials Rules, 2019, ICMR guidelines, and other relevant Indian regulations. It typically includes detailed provisions for trial conduct, subject safety, data management, confidentiality, intellectual property rights, and compensation structures. The agreement is essential for protecting all parties' interests while ensuring regulatory compliance and ethical conduct of clinical research in India.
Suggested Sections

1. Parties: Identification of the contracting parties - typically the sponsor/CRO and the investigator, potentially including the institution

2. Background: Context of the agreement, brief description of the clinical trial, and purpose of the engagement

3. Definitions: Definitions of key terms used throughout the agreement

4. Scope of Services: Detailed description of the investigator's responsibilities and services to be provided

5. Compliance with Protocol: Obligations to follow the trial protocol and applicable guidelines

6. Regulatory Compliance: Compliance with laws, regulations, and ethical guidelines

7. Subject Recruitment and Informed Consent: Requirements for participant recruitment and obtaining informed consent

8. Data Collection and Reporting: Obligations regarding data collection, documentation, and reporting requirements

9. Confidentiality: Provisions for maintaining confidentiality of trial information and data

10. Intellectual Property Rights: Ownership and rights related to study data, inventions, and publications

11. Compensation and Payment Terms: Payment schedule, amounts, and conditions for payment

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

13. Indemnification: Mutual indemnification provisions and liability allocation

14. Insurance: Requirements for maintaining appropriate insurance coverage

15. Governing Law and Jurisdiction: Specification of Indian law as governing law and jurisdiction for disputes

16. General Provisions: Standard boilerplate clauses including notices, amendments, and assignment

Optional Sections

1. Institution Obligations: Used when the institution is a party to the agreement, specifying institutional responsibilities

2. Sub-Investigator Provisions: Include when sub-investigators will be involved in the trial

3. Publication Rights: Detailed provisions for academic publications when working with academic institutions

4. Equipment and Supplies: Include when sponsor is providing specific equipment or supplies for the trial

5. Biological Samples: Include when the trial involves collection and handling of biological samples

6. Data Protection: Detailed data protection provisions when handling sensitive personal data

7. Quality Assurance: Include specific quality control measures when required by sponsor

8. Conflict Resolution: Alternative dispute resolution procedures when preferred over standard litigation

9. Language Requirements: Include when documents need to be maintained in multiple languages

Suggested Schedules

1. Protocol Summary: Summary of the clinical trial protocol

2. Payment Schedule: Detailed breakdown of payment terms, amounts, and milestones

3. Budget: Detailed study budget including per-patient costs and other expenses

4. Required Documentation: List of essential documents to be maintained during the trial

5. Reporting Requirements: Detailed reporting schedules and requirements

6. Insurance Certificates: Copies of required insurance coverage certificates

7. Data Protection Procedures: Detailed procedures for handling and protecting trial data

8. CV and Credentials: Investigator's curriculum vitae and relevant credentials

9. Facility Requirements: Specifications for facility and equipment requirements

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Relevant legal definitions
Clauses
Relevant Industries

Pharmaceuticals

Biotechnology

Healthcare

Clinical Research

Medical Devices

Contract Research Organizations

Hospitals

Academic Medical Centers

Research Institutions

Relevant Teams

Legal

Clinical Operations

Medical Affairs

Regulatory Affairs

Research & Development

Compliance

Quality Assurance

Clinical Research

Contract Management

Site Management

Ethics & Safety

Relevant Roles

Clinical Research Director

Principal Investigator

Medical Director

Clinical Trial Manager

Research Coordinator

Legal Counsel

Regulatory Affairs Manager

Clinical Operations Manager

Medical Affairs Director

Contract Manager

Compliance Officer

Ethics Committee Chairman

Site Director

Research Administrator

Quality Assurance Manager

Industries
Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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