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Clinical Study Agreement

Clinical Study Agreement Template for Germany

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Key Requirements PROMPT example:

Clinical Study Agreement

"I need a Clinical Study Agreement for a Phase II trial of a new diabetes medication, where our German pharmaceutical company will sponsor the research at Berlin University Hospital, with the trial scheduled to start in March 2025 and involving 200 patients."

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Document background
The Clinical Study Agreement is a critical document used when implementing clinical trials in Germany, establishing the legal framework between sponsors, research institutions, and investigators. It ensures compliance with German regulatory requirements, including the Arzneimittelgesetz (AMG), EU Clinical Trials Regulation, and GDPR. The agreement covers essential aspects such as protocol adherence, patient safety, data protection, financial arrangements, and mandatory insurance coverage. It's particularly important in the German context due to specific national requirements for clinical research, including strict ethical committee oversight and detailed patient protection measures. This document is mandatory before initiating any clinical trial and must be reviewed by legal experts familiar with German healthcare law.
Suggested Sections

1. Parties: Identification of the contracting parties (typically the Sponsor, Institution, and Principal Investigator)

2. Background: Context of the clinical study, including the drug/device being studied and relevant regulatory approvals

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

4. Study Conduct: Requirements for conducting the study in accordance with the protocol, GCP, and applicable laws

5. Responsibilities of the Institution: Obligations of the research institution, including facilities, personnel, and compliance

6. Responsibilities of the Principal Investigator: Specific duties of the PI, including protocol adherence and reporting obligations

7. Responsibilities of the Sponsor: Sponsor obligations including study drug supply, monitoring, and regulatory compliance

8. Subject Recruitment and Informed Consent: Requirements for patient recruitment and obtaining informed consent

9. Data Protection and Privacy: GDPR compliance and data protection measures

10. Confidentiality: Confidentiality obligations and permitted disclosures

11. Intellectual Property: Ownership and rights to study data, inventions, and publications

12. Financial Provisions: Payment terms, budget, and financial procedures

13. Insurance and Indemnification: Insurance requirements and indemnification provisions as per German law

14. Term and Termination: Duration of agreement and termination rights

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

Optional Sections

1. Medical Records Access: Specific provisions for sponsor access to medical records - include when direct access is required

2. Sub-investigator Obligations: Include when multiple investigators are involved in the study

3. Equipment Provision: Include when sponsor provides specific equipment for the study

4. Biological Samples: Include when study involves collection and storage of biological samples

5. Publication Rights: Detailed publication procedures - mandatory for academic institutions but optional for private institutions

6. Multi-center Study Provisions: Include for multi-center studies with coordination requirements

7. Third Party CRO: Include when a Contract Research Organization is involved

8. Post-Study Drug Supply: Include when post-study treatment access is provided

Suggested Schedules

1. Schedule 1 - Protocol: The approved clinical trial protocol

2. Schedule 2 - Budget and Payment Schedule: Detailed financial terms, payment schedule, and budget breakdown

3. Schedule 3 - Insurance Certificates: Copies of required insurance certificates

4. Schedule 4 - Data Processing Agreement: GDPR-compliant data processing terms and procedures

5. Schedule 5 - Form of Informed Consent: Approved informed consent form template

6. Schedule 6 - Equipment List: List of equipment provided by sponsor (if applicable)

7. Schedule 7 - Timeline: Study timeline and major milestones

8. Schedule 8 - Personnel List: List of approved study personnel and their roles

9. Appendix A - Confidentiality Agreement: Form of confidentiality agreement for study staff

10. Appendix B - Monitoring Procedures: Detailed monitoring and reporting procedures

Authors

Alex Denne

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

alex.den.21@genieai.co
Relevant legal definitions









































Clauses














































Relevant Industries

Pharmaceutical

Biotechnology

Healthcare

Medical Devices

Clinical Research

Academic Medical Research

Contract Research

Life Sciences

Healthcare Technology

Medical Education

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Clinical Research

Medical Affairs

Compliance

Data Protection

Contract Management

Research Administration

Quality Assurance

Relevant Roles

Clinical Research Director

Principal Investigator

Legal Counsel

Clinical Operations Manager

Research Coordinator

Medical Director

Regulatory Affairs Manager

Data Protection Officer

Clinical Trial Manager

Contract Manager

Chief Medical Officer

Research Ethics Officer

Clinical Research Associate

Compliance Officer

Site Manager

Study Coordinator

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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