A Sponsor-Investigator is a natural person who both initiates and conducts a clinical trial, and under whose immediate direction the investigational product is administered, dispensed, or used. This person combines the duties of the sponsor and those of the investigator; corporations and other non-natural persons are expressly excluded from this definition.
Dual Role with Two Sets of Responsibilities
The definition in ICH E6(R3) is not merely based on someone being professionally involved in a study. The person must initiate and conduct the trial themselves; additionally, the administration, dispensing, or use of the investigational product must be under their immediate direction. Anyone who merely participates as an investigator in an externally initiated study is not a Sponsor-Investigator. Similarly, anyone who finances a study but does not conduct it as an investigator does not fulfill the dual role.
The dual role bundles two separate sets of responsibilities. As the sponsor, the individual is responsible for the initiation, management, and organization of financing, as well as quality management and regulatory study oversight. As the investigator, they are responsible for the conduct at the trial site, medical care, informed consent, and the appropriate delegation of tasks. Combining these duties in one person does not reduce them; rather, it requires clear processes to avoid conflicts of interest and organizational gaps.
Reference to the Regulation and the Institution
Regulation (EU) No. 536/2014 defines sponsor and investigator as independent roles and clarifies that the sponsor and investigator can be the same person. According to the Regulation, the sponsor can be a natural person, a company, an institution, or an organization. In contrast, the narrower ICH definition of a Sponsor-Investigator requires a natural person. A clinic, university, or company can therefore be a sponsor, but not a Sponsor-Investigator in the ICH sense.
In practical implementation, the individual can be supported by an institution, study coordination, or service providers. Delegated tasks must be clearly agreed upon. Support changes neither the investigator’s responsibility for the activities assigned to them nor the sponsor’s responsibility for delegated sponsor tasks. Therefore, the submission must clearly describe who assumes which functions organizationally and how quality, safety, data management, and archiving are guaranteed.
Distinction from Investigator-Initiated Trials and Commercial Studies
A Sponsor-Investigator is a role with a dual set of responsibilities, not a type of study. The related entry ‘investigator-initiated-trial’ refers to a study initiated by an investigator. Such a study is often initiated by a physician and can therefore have a Sponsor-Investigator; however, this is not mandatory. For example, an institution can assume the sponsor role while the initiator remains exclusively the investigator. Conversely, the dual role alone says nothing about the scientific question or the source of funding.
A commercial study is also not a counter-term in the legal sense. In such studies, a pharmaceutical company is typically the sponsor and various natural persons are investigators at the sites. Thus, the roles are regularly separate. However, an academic or non-commercial study can have equally complex regulatory duties. The decisive factor is the sponsor and investigator tasks actually assumed, not the designation “commercial” or “investigator-initiated.”
The dual role also requires a clear separation between the assessment of an individual participant and the evaluation of study-wide findings. Safety data or deviations can affect decisions that involve both one’s own site and other sites. For such situations, communication channels and, if necessary, independent advice should be planned in advance. The documentation must make it clear when the person acted as the treating investigator and when they acted with sponsor-related management responsibility.
Relevance for clinical trials
The dual role is particularly demanding in the planning phase because the person can simultaneously make medical decisions at the site and system-level decisions on the sponsor side. Independent professional advice, documented quality controls, and clear deputy arrangements are therefore important. With multiple sites, the requirements for monitoring, safety surveillance, supply chains, and data management increase significantly; an individual can have these tasks supported organizationally but must ensure the legal and GCP-related framework of responsibility.
Full-service CROs like Mediconomics support Sponsor-Investigators with project management, regulatory submissions, trial site management, monitoring, data management, pharmacovigilance, and medical writing. They can establish responsibility matrices, service provider agreements, safety processes, and Trial Master File structures so that the dual role is organized transparently and the conduct at the sites remains verifiable.
Frequently Asked Questions (FAQ)
Can a university be a Sponsor-Investigator?
No. A university can be a sponsor. However, the term Sponsor-Investigator according to ICH E6(R3) only includes a natural person, not a corporation or institution.
Is every investigator-initiated trial a Sponsor-Investigator study?
No. An investigator-initiated trial describes a type of study. The sponsor role can also be assumed by an institution, while the initiating physician remains the investigator.
Can a Sponsor-Investigator delegate tasks to a CRO?
Yes. Operational tasks can be delegated in writing. However, the duties arising from the sponsor and investigator roles remain within their respective areas of responsibility.
Regulatory References
- ICH E6(R3), Glossary – Definition of the Sponsor-Investigator and their two sets of responsibilities.
- Regulation (EU) No. 536/2014, Article 2, Paragraph 2, Numbers 14 and 15 – Definitions of sponsor and investigator.
- Regulation (EU) No. 536/2014, Article 71 – Sponsor and investigator can be the same person.
- European Commission, CTR Q&A, Section 5.1 – Classification of the sponsor role and the identity of the sponsor and investigator.
