Sponsor

A sponsor means an individual, company, institution or organisation which takes responsibility for the initiation, for the management and for setting up the financing of the clinical trial (Art. 2(2)(14) EU Clinical Trials Regulation 536/2014). A trial may have several co-sponsors who allocate responsibilities by written contract (Art. 72). Where the sponsor is not established in the EU or EEA, it must appoint a legal representative established in the Union who is responsible for ensuring compliance with the Regulation and is the addressee of all communications (Art. 74); some Member States instead accept a contact person.

The sponsor's obligations run through the whole Regulation: submitting the application in CTIS, selecting qualified investigators and suitable sites, ensuring GCP compliance through monitoring and audits, manufacturing and supplying the IMP, safety recording and reporting, notifying serious breaches, maintaining the trial master file for 25 years, publishing results, and arranging insurance or indemnification. Tasks may be delegated to a CRO but responsibility is not transferred (Art. 71).

Under the GDPR the sponsor is the controller for the trial dataset because it determines the purposes and essential means through the protocol; the EDPB Opinion 3/2019 sets out the legal bases it may rely on. A non-EU sponsor recruiting EU participants must also appoint an Art. 27 Data Protection Representative, which is a distinct role from the CTR legal representative although one organisation can hold both. The sponsor conducts the DPIA, concludes processor agreements with vendors, puts transfer safeguards in place, and ensures the informed consent form carries the required GDPR information. iliomad acts as DPO and DPR for sponsors worldwide; see clinical trials compliance services and data protection for biotech and pharma sponsors.