Co-sponsorship exists when a clinical trial has more than one sponsor. As a rule, the co-sponsors jointly bear the sponsor obligations; however, their responsibilities must be set out in writing, and certain tasks must be assigned to exactly one sponsor.
Principle of co-sponsorship
Regulation (EU) No 536/2014 permits one or more sponsors. Where there is more than one sponsor, the co-sponsors are, in principle, jointly liable for fulfilling the sponsor obligations. The Commission Q&A explains this as joint responsibility, including for safety matters: an affected Member State may require any co-sponsor to fulfil a sponsor obligation. Co-sponsorship is therefore not suitable as a mere division of labour without shared regulatory responsibility.
It may be considered, for example, for academic networks, research institutions, or collaborations that jointly initiate, manage, and fund a study. Governance, decision-making authority, information exchange, and documentation must be clarified already at the planning stage. For studies with multiple sponsors, ICH E6(R3) requires a documented agreement on their respective responsibilities. If a specific responsibility is not assigned to any sponsor in that agreement, it rests with all sponsors under ICH.
Tasks that must be assigned individually
Article 72 of the Regulation requires the co-sponsors to jointly determine in a written contract which sponsor is responsible for three tasks. First, this concerns fulfilment of sponsor obligations in the authorisation procedure, including substantial modifications and the addition of another concerned Member State. Second, one sponsor must be designated as the contact point for questions from participants, investigators, and Member States. Third, one sponsor must implement corrective measures ordered by the authorities.
Shared responsibility is excluded for each of these tasks. The Commission Q&A clarifies that the relevant task must in each case be assigned to a single sponsor; while that sponsor may delegate individual activities to third parties, it remains the responsible sponsor. The remaining sponsor obligations may be allocated differently among the co-sponsors by contract. If no such arrangement is made, joint responsibility continues to apply. The sponsor responsible in the authorisation procedure requires full access to the documents and information needed for that purpose.
Distinction from a single contract and legal representative
Co-sponsorship is not a loose cooperation agreement between institutions, nor is it the same as outsourcing services to a CRO. Co-sponsors are themselves sponsors with a regulatory set of obligations. A CRO or other service provider may take on tasks, but does not thereby become a co-sponsor as long as it does not assume responsibility for initiating, managing, and setting up the financing of the trial. The neighbouring entry “Sponsor” describes the single role; co-sponsorship describes its multi-party configuration.
It must also be distinguished from the legal representative. If a sponsor is not established in the Union, a legal representative established in the Union must generally be appointed to ensure fulfilment of the sponsor obligations. A legal representative acts on behalf of a sponsor; this does not in itself make them a co-sponsor. Where there are multiple sponsors not established in the Union, the requirements for each concerned sponsor and the specific contractual structure must be assessed.
The contractual allocation is only robust vis-à-vis authorities and trial sites if it is implemented operationally. Contact details, decision timelines, and representation rules should be consistent with the CTIS submission, safety communications, and the sites’ documentation. If the collaboration changes—for example, due to the withdrawal of a co-sponsor or new sites in additional Member States—it must be assessed whether the contract, role description, and regulatory documents need to be updated. Joint responsibility remains the starting point for any change.
Relevance for clinical trials
The high need for coordination lies less in naming multiple sponsors than in a robust decision-making architecture. Without a clear contact point, safety information or regulatory queries may be answered with delay. Without clear access to information, the sponsor responsible for the authorisation procedure cannot fulfil its obligations. Contracts should therefore not only list responsibilities, but also provide practical arrangements for escalation, representation, data access, changes, and collaboration with service providers.
Full-service CROs such as Mediconomics support the development of governance and responsibility matrices, coordination of submission documentation, establishment of a regulatory contact point, and documentation of information flows. They can coordinate project management, safety communications, monitoring, and data management between multiple sponsors, and provide organisational support for the implementation and follow-up of authority-ordered corrective measures.
Frequently Asked Questions (FAQ)
Are all co-sponsors responsible for safety matters?
In principle, yes. As a rule, the co-sponsors jointly bear the sponsor obligations; a specific contractual allocation changes the statutory default only within the framework provided for.
May the contact point consist of multiple co-sponsors?
No. The function as contact point for questions from participants, investigators, and Member States must be assigned to a single sponsor.
Is an EU legal representative automatically a co-sponsor?
No. The legal representative acts for a sponsor not established in the Union and ensures fulfilment of the sponsor obligations. This role must be distinguished from co-sponsorship.
Regulatory References
- Regulation (EU) No 536/2014, Article 71 – possibility of multiple sponsors and written delegation of tasks.
- Regulation (EU) No 536/2014, Article 72 – joint responsibility and mandatory assignment of three tasks to a single sponsor.
- Regulation (EU) No 536/2014, Article 74 – legal representative of a sponsor not established in the Union.
- ICH E6(R3), Section 3.6.11 – documented responsibility agreement for multiple sponsors.
