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Investigator Agreement
1. Parties: Identification of the contracting parties - typically the Sponsor/CRO and the Investigator, including full legal names and addresses
2. Background: Context of the clinical trial, including study identification and purpose
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 Laws and Regulations: Obligations to comply with Danish laws, EU regulations, GCP, and other applicable requirements
6. Protocol Adherence: Requirements for following the study protocol and managing protocol deviations
7. Subject Recruitment and Informed Consent: Procedures for participant recruitment and obtaining informed consent
8. Data Collection and Reporting: Requirements for data collection, recording, and reporting, including adverse events
9. Confidentiality: Provisions for maintaining confidentiality of study information and results
10. Data Protection: GDPR compliance and data protection requirements specific to Denmark
11. Publication Rights: Terms governing the publication of study results and academic freedom
12. Compensation and Payment Terms: Payment schedule, amounts, and conditions for payment
13. Term and Termination: Duration of the agreement and conditions for termination
14. Insurance and Indemnification: Insurance requirements and indemnification provisions
15. Governing Law and Jurisdiction: Specification of Danish law as governing law and jurisdiction for disputes
16. General Provisions: Standard contractual provisions including amendments, assignments, and notices
1. Institution Involvement: Required when the Investigator is affiliated with an institution that needs to be party to the agreement
2. Sub-Investigator Obligations: Needed when sub-investigators will be involved in the study
3. Equipment and Supplies: Include when specific equipment or supplies are provided for the study
4. Biological Samples: Required when the study involves collection and handling of biological samples
5. Intellectual Property Rights: Needed when there's potential for new IP development during the study
6. Study Drug Management: Include for studies involving investigational medicinal products
7. Quality Assurance: Detailed quality control procedures when beyond standard requirements
8. Translation Requirements: Include when study materials require translation
9. Conflict Resolution: Specific dispute resolution procedures beyond standard jurisdiction clause
1. Schedule A - Protocol: Summary or reference to the approved clinical trial protocol
2. Schedule B - Budget and Payment Schedule: Detailed breakdown of payments, including visit fees, procedures, and payment timing
3. Schedule C - Timeline: Study timeline including key milestones and deadlines
4. Schedule D - Data Processing Agreement: GDPR-compliant data processing terms and requirements
5. Schedule E - Division of Responsibilities: Detailed matrix of responsibilities between parties
6. Appendix 1 - Form of Informed Consent: Approved informed consent template
7. Appendix 2 - CV and Licenses: Investigator's curriculum vitae and professional licenses
8. Appendix 3 - Insurance Certificates: Copies of required insurance documentation
9. Appendix 4 - Monitoring Requirements: Specific monitoring procedures and requirements
Authors
Applicable Law
Approval
Budget
Case Report Form (CRF)
Clinical Trial
Confidential Information
Contract Research Organization (CRO)
Data Protection Laws
Effective Date
Ethics Committee
Good Clinical Practice (GCP)
Institution
Investigational Product
Investigator
Investigator's Brochure
Medical Records
Monitor
Patient
Personal Data
Principal Investigator
Protocol
Regulatory Authority
Research Staff
Sample
Serious Adverse Event
Site
Sponsor
Study
Study Data
Study Subject
Sub-Investigator
Study Timeline
Subject Information Sheet
Informed Consent Form
Trial Master File
Danish Medicines Agency
Study Completion
Publication
Background IP
Foreground IP
Study Materials
Results
Research Ethics Committee
Trial-related Documents
Documentation
Quality System
Source Documents
Study Report
Danish Data Protection Authority
Recitals
Definitions
Appointment
Scope of Services
Compliance
Protocol Adherence
Regulatory Compliance
Study Conduct
Patient Recruitment
Informed Consent
Data Collection
Record Keeping
Reporting Obligations
Safety Reporting
Confidentiality
Data Protection
Quality Assurance
Monitoring Rights
Publication Rights
Intellectual Property
Compensation
Payment Terms
Insurance
Indemnification
Liability
Term
Termination
Force Majeure
Assignment
Amendments
Notices
Governing Law
Dispute Resolution
Severability
Entire Agreement
Survival
Representation and Warranties
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