Standard Contractual Clauses for Clinical Trial Agreements

With the Regulation on the Simplification of the Conduct and Authorisation of Clinical Trials (“StandVKlV”), binding standard contractual clauses for agreements for clinical trials of medicinal products in Germany were published on 18 September 2025. The aim is to standardise minimum content requirements in agreements between sponsors and trial sites. This is intended to shorten contract negotiations, which have often been lengthy and complex, and to harmonise contractual practice. In this way, the German pharmaceutical strategy is to be implemented, which aims to counteract the decline of clinical trials in Germany and to prevent the migration of pharmaceutical development projects.

The standard contractual clauses are to be applied to certain agreements on clinical trials of medicinal products concluded between commercial sponsors and trial sites in Germany from 18 December 2025 onwards.

Legal Nature and Applicability

The standard contractual clauses constitute binding minimum content requirements for clinical trial agreements concluded between a commercial sponsor and a trial site for the conduct of a clinical trial with medicinal products. In the case of an investigator-initiated clinical trial (IIT), in which a non-commercial sponsor (such as a university) conducts the clinical trial, the standard contractual clauses do not apply.

The standard contractual clauses are not suitable for replacing complete contracts. This is mainly due to the fact that not all provisions necessary for a contract have been included in the standard contractual clauses. Rather, only those provisions that are considered particularly negotiation-intensive in practice have been included.

The standard contractual clauses are, in principle, binding. However, pursuant to Section 42d para 2 of the German Medicinal Products Act, the parties may mutually agree on deviations, amendments and supplements.

Key Content of the Standard Contractual Clauses

The standard contractual clauses not only cover essential areas such as name and trademark rights, but also regulate the provision of equipment and materials, inspections and audits, as well as documentation and archiving. In addition, they contain provisions on data protection and on the modalities of termination and cancellation. Overall, a clearly structured and comprehensive set of clauses has been developed, which largely adheres to compromises established in practice.

Key content also includes:

• Publication Rights: The standard contractual clauses leave statutory publication obligations unaffected, but grant the sponsor a right to first publication of the study results. If the sponsor does not make a first publication within twelve months after completion of the clinical trial, the trial site is entitled to publish the results generated at the trial site for non-commercial scientific purposes in compliance with the procedure set out in clauses 1.2 and 1.3. It is irrelevant whether the results are favourable or unfavourable. It is noteworthy that the standard contractual clauses take into account that confidential information and intellectual property rights of the sponsor are, at the sponsor’s request, excluded from publication. This corresponds to common contractual practice.
• Rights to Protectable Results: The standard contractual clauses provide that the trial site shall promptly inform the sponsor of protectable inventions within the meaning of the German Employee Inventions Act (“ArbnErfG”), to the extent legally permissible. The sponsor receives an exclusive option right to the transfer of inventions arising at the trial site in the course of the contractual and protocol-compliant conduct of the clinical trial. With regard to invention remuneration, the parties may choose between a market-standard lump-sum or recurring payment based on the ArbnErfG and a fixed amount. An option whereby protectable inventions are already included in the budget does not exist.
• Rights to Non-Protectable Results: Rights to results generated or produced by the trial site in the course of the contractual and protocol-compliant conduct of the clinical trial that do not constitute protectable inventions are, as is market standard, assigned to the sponsor in advance. For copyrights, the trial site grants the sponsor an exclusive licence. The transfer or granting of rights to non-protectable results is already covered by the agreed remuneration.
• License for the Trial Site: It is provided that the trial site receives a free-of-charge, non-exclusive licence to use all results generated by the trial site. It should be noted that this licence also covers protectable results.
• Confidentiality: Confidential information comprises, subject to clause 3.2, in principle all information relating to the clinical trial, to the performance of the contract and all results. There are no confidentiality obligations of the sponsor with regard to results generated in accordance with the contract and the trial protocol.
• Liability: The standard contractual clauses limit the liability of trial sites for slight negligence in terms of amount.

Need for Adaptation in Practice 

The standard contractual clauses are intended to standardise and harmonise provisions that are particularly negotiation-intensive. However, they do not constitute a complete contract template, which is why the clinical trial agreement using the standard contractual clauses must also be tailored to the individual case.

In particular, sponsors should consider the following aspects:

• Customary Provisions: Provisions such as a jurisdiction clause or an arbitration agreement, provisions on assignability, the engagement of vicarious agents or indemnification claims are not part of the standard contractual clauses, but are typically part of the content of a contract. Corresponding provisions should therefore be included in addition to the standard contractual clauses.
• Provisions on the Performance of Services: Provisions on the precise performance of services by the trial site, the standard of care and the obligations under applicable laws are also not covered by the standard contractual clauses, but should be defined in order to establish clear performance obligations and responsibilities.
• Particularities Regarding University Inventions: As already mentioned, the trial site is only obliged to disclose employee inventions if this is provided for under the ArbnErfG. In contractual practice, the bridge to the ArbnErfG will still need to be built: University employees are not legally obliged to disclose inventions (negative freedom of publication). A transfer to the sponsor may therefore fail without further provisions, as the trial site may not become aware of the invention.

Supplementary Contract Template

In order to minimise the aforementioned need for adaptation in practice, representatives from academia and industry have already published, in addition to the StandVKlV, a complete standard contract template as a model in German and English. The contract template integrates the legally prescribed standard contractual clauses with further provisions established in practice and is designed to be used as a self-contained contractual framework. Since the template was developed with the participation of stakeholders from both pharmaceutical sponsors and trial sites, it reflects a balanced consideration of the respective economic interests. Nevertheless, despite the balanced design of the template, sponsors should carefully examine whether the provisions envisaged are consistent with their internal requirements and processes. Where appropriate, the use of the contract template can contribute to simplifying and overall accelerating contract negotiations between sponsors and trial sites.

Outlook

With the binding nature of the standard contractual clauses for clinical trial agreements concluded from 18 December 2025 onwards, the contractual design of clinical trials will undergo a complete paradigm shift. It will only become apparent in practical application to what extent the standard contractual clauses will continue to offer the contracting parties room for manoeuvre in the future.

In practice, it is becoming apparent that trial sites will demand the application of the standard contractual clauses and invoke their binding and negotiation-accelerating character. Sponsors should, in this case, adapt their existing contract templates to the standard contractual clauses and examine which amendments or additional provisions are necessary for them. Insofar as sponsors are considering the use of the published complete contract templates, they should, as part of this decision, also examine whether the provisions contained therein meet the respective specific requirements.