What does "sponsor" mean in clinical investigations?

The captain of the clinical investigation: How the sponsor holds the helm‍

Clinical investigations of medical devices are like a voyage on the high seas - there are many uncertainties and challenges to overcome. From designing the protocol to reporting the results, it is up to the sponsor to take overall responsibility for navigation. Whether it is a medical device manufacturer, research institution or other organisation, the sponsor has overall responsibility for the proper conduct of the clinical investigation. This responsibility is paramount to ensure the safety of trial participants, maintain data integrity and ensure compliance with all regulatory requirements.

Where can you find all the requirements?

The tasks of the sponsor in clinical investigations of medical devices are comprehensive and regulated by various European and national (in this case German) regulations and guidelines, in particular Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), the Medical Devices Implementation Act (MPDG), ISO 14155:2021-05 and the documents of the Medical Device Coordination Group (MDCG).

What are the specific requirements for sponsors?

‍Here is an indicative summary of the sponsor's most important tasks:

1. responsibility and liability

• has overall responsibility and liability for the initiation, management, funding and quality assurance of the clinical investigation.
• Ensures that the trial is conducted in accordance with applicable regulations and standards such as MDR, IVDR, ISO 14155 and national laws.

2. preparation of and compliance with the test plan

• Prepares a detailed study plan that reflects current scientific knowledge and describes all aspects of the study.
• Ensures that the study is conducted in accordance with the approved study plan.

3 Authorisation procedure and reporting obligations

• submits the necessary applications and documents for approval of the test to the competent authorities.
• Reports serious adverse events, device deficiencies and other incidents to the authorities in a timely manner.‍

4. risk management and safety monitoring

• Implements a risk management and safety monitoring system for the clinical investigation.
• Identifies, assesses and controls risks throughout the trial.

5. selects and monitors trial centres and investigators

• Selects suitable trial centres and qualified investigators and appoints a clinical investigation manager.
• Monitors compliance with the trial protocol and regulations through regular audits and visits.

6. data management and reporting

• Ensures the integrity and quality of the data collected.
• prepares reports on the audit results and presents them to the authorities and the public.‍

7. outsourcing and delegation of tasks

• can transfer certain tasks to qualified third-party organisations, but remains ultimately responsible.
• Delegated tasks must be clearly defined and contractually stipulated.

These comprehensive tasks of the sponsor serve to ensure the safety of study participants, maintain data integrity and ensure compliance with all regulatory requirements.

The sponsor therefore plays a crucial role in ensuring the quality and integrity of clinical investigations or clinical studies and contributes to the safety of participants and the validity of study results.

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As a manufacturer, we will provide you with constant consultation and support right from the start. For more information or an initial non-binding discussion please contact us.

(as of spring 2024)

Literature and references are available on request.