This article covers the responsibilities of the sponsor – one of the most important stakeholders in a clinical investigation.
If you want to know more about sponsor responsibilities, have a look at the video below from the course Clinical Investigation for Medical Devices and ISO 14155.
The clinical investigation sponsor, whether it is an individual or a company, has many responsibilities. The main sponsor responsibilities are:
The sponsor shall also ensure that the clinical investigation is designed, conducted, and monitored in compliance with ISO 14155.
Clinical quality management is done by implementing clinical quality procedures, maintaining records of stakeholder compliance, assuring auditing requirements are met and justifying and documenting accepted exceptions to the requirements of ISO 14155.
The continued communication with the local and international regulatory authorities shall be managed by the sponsor, including obtaining approval from applicable countries and for amended documents, developing progress and status reports, reporting adverse events and any withdrawal of an investigational device for safety reasons.
The sponsor is responsible for the planning and conduct of the clinical investigation. This comprises a wide series of duties such as:
The sponsor has a lot of responsibilities, but certain functions can be delegated to clinical research organisations (CROs) or individual contractors.
Transferring duties and functions to a third-party organisation, such as a clinical research organisation, can be a big help for the sponsor. However, this cannot be done lightly. There are a series of considerations that need to be managed appropriately and this must be documented in written agreements.
Although the sponsor can transfer some or even all clinical investigation-related duties to a CRO or contractor, it does not release the sponsor from its main function – the sponsor is always ultimately responsible for the clinical investigation.
Take a look at our online Clinical Investigation for Medical Devices and ISO 14155 course that focuses on good clinical practice (GCP) for the design, conduct, recording, and reporting of clinical investigations carried out on human subjects to assess the clinical performance or effectiveness and safety of medical devices.
The course covers an orientation of the clinical investigation process according to the EN ISO 14155:2020 standard and the standard’s relation to MDCG guidance documents. This practical course is suitable for anyone working in clinical research and medical device development, such as regulatory affairs associates, QA engineers, and clinical research specialists.
Maria Nyåkern, Ph.D., is a clinical research expert, consultant, and educator specialising in medical device clinical investigations. She is the founder of a prominent medical device CRO and has supported early-stage start-ups to large multinational organisations, setting up and managing clinical investigations involving tens of thousands of patients, including projects for many of the world’s leading medical device manufacturers.
She is an international expert and a Swedish representative on the ISO technical committees SIS/TK 340 and ISO/TC 194 (Biological and clinical evaluation of medical devices), contributing to the development of ISO 14155 and ISO 18969. Maria specialises in clinical evaluation and clinical investigations in accordance with EU MDR 2017/745 and ISO 14155 and ISO 18969.
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Plan, manage, and monitor clinical investigations aligned with ISO 14155 and GCP; from clinical sites to data reporting.
