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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."
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
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
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
Applicable Law
Approval
Biological Samples
Case Report Form
Clinical Trial
Confidential Information
Contract Research Organization
DCGI
Drug Controller General of India
Effective Date
Ethics Committee
FDA
GCP
Good Clinical Practice
ICMR
Informed Consent Form
Institution
Intellectual Property Rights
Investigation Site
Investigational Product
Investigator Brochure
Investigator
Medical Records
Monitor
Patient
Protocol
Regulatory Authority
Research Data
Research Subject
Serious Adverse Event
Source Documents
Sponsor
Study
Sub-Investigator
Subject
Study Materials
Study Personnel
Study Protocol
Term
Territory
Trial Site
Trial Subject
Appointment
Services
Compliance
Protocol Adherence
Regulatory Compliance
Ethics Committee
Subject Recruitment
Informed Consent
Data Collection
Record Keeping
Reporting Requirements
Safety Reporting
Quality Assurance
Monitoring
Confidentiality
Data Protection
Intellectual Property
Publication Rights
Compensation
Payment Terms
Representations and Warranties
Indemnification
Insurance
Term
Termination
Force Majeure
Assignment
Governing Law
Dispute Resolution
Notices
Entire Agreement
Amendment
Severability
Waiver
Counterparts
Pharmaceuticals
Biotechnology
Healthcare
Clinical Research
Medical Devices
Contract Research Organizations
Hospitals
Academic Medical Centers
Research Institutions
Legal
Clinical Operations
Medical Affairs
Regulatory Affairs
Research & Development
Compliance
Quality Assurance
Clinical Research
Contract Management
Site Management
Ethics & Safety
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
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