Clinical Trial Agreement Template for Germany

1. Sub-Investigator Obligations: Used when sub-investigators have specific obligations that need to be detailed

2. Equipment and Materials: Include when sponsor provides specific equipment or materials for the trial

3. Biological Samples: Required when trial involves collection and storage of biological samples

4. Multi-Center Trial Provisions: Include for multi-center trials with specific coordination requirements

5. Third Party Agreements: Used when CROs or other third parties are involved in trial conduct

6. Subject Recruitment: Include when specific recruitment procedures or targets need to be detailed

7. Pharmacovigilance: Detailed section needed for drug trials with specific safety reporting requirements

8. Post-Trial Access: Include when addressing post-trial access to study medication

9. Data Monitoring: Required for trials with specific data monitoring committee requirements

1. Protocol: Full clinical trial protocol or protocol summary

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

3. Patient Information and Consent Forms: Approved forms for patient information and consent

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

5. Insurance Certificate: Copy of required insurance documentation

6. Personnel and Responsibilities: List of key personnel and their responsibilities

7. Monitoring Requirements: Detailed monitoring procedures and requirements

8. Quality Requirements: Quality assurance and control procedures

9. Form of Safety Reports: Templates and procedures for safety reporting

10. Equipment List: Detailed list of provided equipment and maintenance requirements