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.
Create a bespoke document in minutes, or upload and review your own.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Get your first 2 documents free
Your data doesn't train Genie's AI
You keep IP ownership聽of your information
Key Requirements PROMPT example:
Clinical Site Agreement
I need a Clinical Site Agreement under Danish law for a Phase III pharmaceutical trial starting March 2025, where our CRO will be managing multiple sites across Denmark for a new diabetes treatment.
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
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
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
Relevant legal definitions
Clauses
Relevant Industries
Pharmaceuticals
Healthcare
Clinical Research
Biotechnology
Medical Devices
Contract Research Services
Healthcare Technology
Relevant Teams
Legal
Clinical Operations
Regulatory Affairs
Research and Development
Compliance
Quality Assurance
Finance
Data Protection
Clinical Research
Contract Management
Medical Affairs
Relevant Roles
Clinical Research Director
Legal Counsel
Clinical Operations Manager
Principal Investigator
Research Coordinator
Regulatory Affairs Manager
Contracts Manager
Clinical Trial Manager
Data Protection Officer
Medical Director
Site Manager
Quality Assurance Manager
Clinical Research Associate
Compliance Officer
Finance Manager
Find the exact document you need
Clinical Site Agreement
Danish-law governed agreement establishing the framework for conducting clinical trials at healthcare institutions, ensuring compliance with local and EU regulations.
find out more
Data Transfer Agreement Clinical Trial
Danish-law governed Data Transfer Agreement for clinical trials, ensuring GDPR and local regulatory compliance for transfer of clinical trial data.
find out more
Download our whitepaper on the future of AI in Legal
By providing your email address you are consenting to our Privacy Notice.
骋别苍颈别鈥檚 Security Promise
Genie is the safest place to draft. Here鈥檚 how we prioritise your privacy and security.
Your documents are private:
We do not train on your data; 骋别苍颈别鈥檚 AI improves independently
All data stored on Genie is private to your organisation
Your documents are protected:
Your documents are protected by ultra-secure 256-bit encryption
Our bank-grade security infrastructure undergoes regular external audits
We are ISO27001 certified, so your data is secure
Organizational security
You retain IP ownership of your documents
You have full control over your data and who gets to see it
Innovation in privacy:
Genie partnered with the Computational Privacy Department at Imperial College London
Together, we ran a 拢1 million research project on privacy and anonymity in legal contracts
Want to know more?
Visit our for more details and real-time security updates.
Read our Privacy Policy.