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 Introduction to Clinical Investigation for Medical Devices and ISO 14155. 

The main responsibilities of a sponsor

The clinical investigation sponsor, whether it is an individual or a company, has many responsibilities. The main sponsor responsibilities are: 

  • Clinical quality management 
  • Communication with regulatory authorities 
  • Clinical investigation planning and conduct
  • Outsourcing duties and functions 

The sponsor shall also ensure that the clinical investigation is designed, conducted, and monitored in compliance with ISO 14155. 

Clinical quality management

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. 

Communication with regulatory authorities

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. 

Clinical investigation planning and conduct

The sponsor is responsible for the planning and conduct of the clinical investigation. This comprises a wide series of duties such as: 

  • Selection and training of clinical personnel 
  • Preparation of documents and material
  • Conduction of clinical investigation
  • Monitoring and site-required visits
  • Safety evaluation and reporting 
  • Clinical investigation close-out 

The sponsor has a lot of responsibilities, but certain functions can be delegated to clinical research organisations (CROs) or individual contractors. 

Delegating duties and functions to third parties

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. 

Would you like to know more about 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.

Introduction to Clinical Investigation online course
Maria Nyakern

Maria Nyåkern

Maria Nyåkern, Ph.D., is a consultant, entrepreneur, and B2B service provider in the medical device industry; she is the founder of AKRN Scientific Consulting, a CRO specializing in medical devices and minimally invasive cardiovascular therapies.

Maria is also a valued and respected trainer on clinical evaluation and clinical investigations of medical devices according to the EU MDR 2017/745 and the ISO 14155:2020 standard. She has vast ‘ hands-on’ experience, having set up and managed dozens of clinical investigations, and tens of thousands of patients, for different medical devices and indications for many of the top ten medical device manufacturers in the industry.