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Clinical Site Agreement

Clinical Site Agreement Template for Denmark

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Clinical Site Agreement

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Document background
The Clinical Site Agreement is a crucial document used when establishing a formal relationship between a trial sponsor (typically a pharmaceutical company or CRO) and a healthcare institution for conducting clinical trials in Denmark. This agreement type is essential for ensuring compliance with Danish medical regulations, EU Clinical Trials Regulation 536/2014, and data protection laws. It defines the terms under which the clinical trial will be conducted, including roles, responsibilities, financial arrangements, and compliance requirements. The document is specifically adapted to the Danish healthcare system and regulatory environment, incorporating local legal requirements while maintaining alignment with EU standards. It serves as the primary contractual framework protecting all parties' interests while ensuring patient safety and research integrity.
Suggested Sections

1. Parties: Identification of contracting parties including Sponsor/CRO and Healthcare Institution

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

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

4. Scope of Services: Overview of clinical trial services to be provided and general obligations

5. Regulatory Compliance: Compliance requirements with Danish laws, EU regulations, and GCP guidelines

6. Study Team and Personnel: Requirements and responsibilities of principal investigator and study staff

7. Patient Recruitment and Informed Consent: Process and requirements for patient recruitment and obtaining informed consent

8. Data Protection and Confidentiality: GDPR compliance, data handling, and confidentiality obligations

9. Financial Terms: Payment terms, schedule, and financial obligations

10. Publication Rights: Terms for publishing study results and academic rights

11. Intellectual Property: Ownership and rights to study data, results, and innovations

12. Insurance and Indemnification: Insurance requirements and indemnification provisions under Danish law

13. Term and Termination: Duration of agreement and termination provisions

14. General Provisions: Standard legal provisions including governing law, dispute resolution, and notices

Optional Sections

1. Equipment and Supplies: Used when sponsor provides specific equipment or supplies for the study

2. Biological Samples: Include when study involves collection and handling of biological samples

3. Sub-contracting: Required when site needs to engage third-party services

4. Quality Assurance: Detailed quality control measures, needed for complex studies

5. Archive and Record Retention: Specific requirements beyond standard record keeping

6. Translation Requirements: Include when documents need translation between English and Danish

7. Subject Injury Provisions: Detailed procedures for handling patient injuries during trial

Suggested Schedules

1. Schedule 1 - Study Protocol Synopsis: Summary of the clinical trial protocol

2. Schedule 2 - Budget and Payment Schedule: Detailed breakdown of costs and payment terms

3. Schedule 3 - Timeline and Milestones: Study timeline and key performance indicators

4. Schedule 4 - Personnel and Responsibilities: List of key staff and their roles

5. Schedule 5 - Required Documentation: List of essential documents for regulatory compliance

6. Schedule 6 - Data Processing Agreement: GDPR-compliant data processing terms

7. Schedule 7 - Facility and Equipment Requirements: Specifications for facility and equipment needs

8. Appendix A - Form of Informed Consent: Template for patient informed consent

9. Appendix B - Confidentiality Agreement: Template for staff confidentiality agreements

Authors

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Relevant legal definitions
Agreement
Applicable Law
Approval
Biological Sample
Case Report Form (CRF)
Clinical Trial
Confidential Information
Data Protection Laws
Effective Date
Ethics Committee
Facility
GCP (Good Clinical Practice)
Institution
Intellectual Property Rights
Investigational Product
Investigator Brochure
Medical Records
Monitor
Patient
Personal Data
Principal Investigator
Protocol
Quality Assurance
Regulatory Authority
Research Staff
Serious Adverse Event
Site
Source Documents
Sponsor
Study
Study Data
Study Subject
Study Team
Sub-Investigator
Trial Master File
Trial Results
Danish Medicines Agency
Informed Consent Form
Payment Schedule
Study Materials
Background IP
Foreground IP
Study Completion
Study Initiation
Trial-related Documents
Protocol Deviation
Data Processing Agreement
Study Budget
Subject Injury
Publication Rights
Clauses
Parties and Background
Definitions
Services
Compliance
Clinical Trial Conduct
Patient Recruitment
Informed Consent
Data Protection
Confidentiality
Documentation
Record Keeping
Quality Assurance
Monitoring
Regulatory Inspections
Safety Reporting
Insurance
Indemnification
Intellectual Property
Publication Rights
Financial Provisions
Payment Terms
Study Materials
Equipment
Personnel Requirements
Representations and Warranties
Term and Termination
Force Majeure
Assignment
Subcontracting
Governing Law
Dispute Resolution
Notices
Amendments
Entire Agreement
Severability
Relevant Industries
Relevant Teams
Relevant Roles
Industries
Danish Medicines Act (Lægemiddelloven): Primary legislation governing clinical trials and medical research in Denmark, implementing EU Clinical Trials Regulation 536/2014
EU Clinical Trials Regulation 536/2014: European regulation setting standards for clinical trials across the EU, including requirements for conducting trials and protecting participants
Danish Health Act (Sundhedsloven): Regulates healthcare services, patient rights, and responsibilities of healthcare providers in Denmark
General Data Protection Regulation (GDPR): EU regulation on data protection and privacy, crucial for handling patient data in clinical trials
Danish Data Protection Act (Databeskyttelsesloven): National implementation of GDPR, providing specific requirements for processing personal data in Denmark
Danish Contracts Act (Aftaleloven): Governs formation and enforcement of contracts under Danish law
Danish Product Liability Act (Produktansvarsloven): Relevant for liability aspects related to medical products and devices used in clinical trials
Good Clinical Practice (GCP) Guidelines: International ethical and scientific quality standards for clinical trials that must be followed in Denmark
Danish Committee Act on Research Ethics (Komitéloven): Regulates ethical approval requirements for clinical trials and medical research
Danish Professional Liability Act (Klage- og erstatningsloven): Governs professional liability and compensation in healthcare sector
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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