#BGBl. 2025 I Nr. 215Regulation on Standard Contractual Clauses for the Conduct of Clinical Trials
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This German federal regulation, published on 18 September 2025 in the Federal Law Gazette (BGBl. 2025 I Nr. 215), introduces standardized contractual clauses to simplify and standardize the conduct and approval of clinical trials in Germany. Issued by the Federal Ministry of Health on 16 September 2025, it aims to reduce administrative burdens for sponsors, investigators, and contract research organizations by providing pre-approved contractual language that ensures compliance with EU and national requirements for data protection, liability, and trial governance. The regulation forms part of broader efforts to make Germany more attractive for clinical research by harmonizing contract terms across trial sites and reducing negotiation time. It applies to all clinical trials of medicinal products and medical devices that require approval or notification under the relevant German medicines and medical devices laws.
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Key Changes
- Introduces mandatory use of standardized contractual clauses for all clinical trials of medicinal products and medical devices
- Simplifies approval procedures by reducing individual contract negotiations between sponsors and trial sites
- Establishes uniform rules on data protection, liability allocation, and intellectual property in clinical trial contracts
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Obligations
What this law requires
Use standardized contractual clauses provided in this regulation for all clinical trials of medicinal products and medical devices requiring approval or notification under German medicines and medical devices laws
Ensure contractual terms comply with EU data protection requirements as specified in the standardized clauses
Ensure contractual terms comply with national data protection requirements as specified in the standardized clauses
Include liability provisions as defined in the standardized contractual clauses in all clinical trial agreements
Establish trial governance procedures according to the standardized clauses in contractual agreements