The new article highlights specific aspects of a clinical investigation plan, such as the approach to be followed concerning the deviations or informed consent and how it should be obtained before commencing a study.
Table of content
The Medical Device Coordination Group (MDGC), an advisory body comprised of the representatives of the EU Member States focused on the general improvement of the regulatory framework in the sphere of medical devices, has published a guidance document dedicated to the content of the clinical investigation plan for clinical investigations of medical devices.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers, study sponsors, and other parties involved in operations with medical devices, including clinical investigations, to ensure compliance with it.
At the same time, MDCG reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation or accommodate the recent technology developments and arising needs.
In particular, the document describes in detail the content of a Clinical Investigation Plan (CIP) to be prepared by the responsible parties, highlighting the key aspects to be considered.
Modifications of the Clinical Investigation Plan (CIP)
First of all, the document emphasizes the necessity for a robust and transparent mechanism within the Clinical Investigation.
Plan to promptly notify relevant competent authorities about any proposed amendments that could significantly affect the subjects’ safety, health, or rights or compromise the integrity and reliability of the clinical data.
It underscores the requirement, as mandated by Article 75 of the Medical Device Regulation, for the investigator to hold off on implementing these changes until either the specified waiting period has elapsed or explicit approval has been granted, whichever comes first.
The document also explains the approach to be applied to the strategies and protocols for addressing modifications to the CIP deemed non-substantial.
It includes a comprehensive description of how these minor amendments will be documented, reviewed, and integrated into the ongoing clinical investigation without undermining its safety standards or data integrity, ensuring continuous adherence to regulatory guidelines.
Deviations from the CIP
The guidance further emphasizes that deviations from the approved CIP are not allowed unless necessary to safeguard the participants’ rights, safety, and well-being under emergent conditions.
It also outlines the circumstances under which deviations may occur, ensuring the participants’ safety while maintaining the integrity of the clinical investigation.
To assist the parties involved with following the relevant requirements, the document also describes the procedures framework for recording, reporting, and analyzing deviations from the CIP, including the appropriate steps for implementing corrective and preventive actions, the criteria for evaluating the severity of deviations, and the potential for principal investigator disqualification based on the nature and frequency of these deviations.
Device Accountability
The relevant section of the guidance describes the procedural safeguards and logistical arrangements necessary for the proper accountability and traceability of the investigational device.
It covers the control measures for access, the criteria for adequate storage, and protocols for device follow-up, aiming to ensure that investigational devices are used exclusively as intended within the clinical investigation framework.
It is also important to mention that the record-keeping procedures related to clinical investigations are also subject to strict and detailed requirements ensuring that every aspect of the device’s lifecycle is meticulously documented, facilitating transparency and traceability, including the specifics of record-keeping concerning the receipt, usage, return, and disposal of the device
Statements of Compliance
By the existing legal framework, a party responsible for the clinical investigation should achieve and sustain compliance with the relevant regulatory requirements introduced by the MDR, the Declaration of Helsinki, and applicable standards, such as ISO 14155.
According to the guidance, compliance with it is vitally crucial for ensuring the accuracy and reliability of study results.
Informed Consent Process
Another critical concept described in the guidance is the concept of informed consent, which is to be provided by a study participant before the relevant procedures are conducted.
The relevant part describes the process for obtaining informed consent, detailing the mechanisms for informing participants, compensating them, and addressing situations where participants cannot consent.
It emphasizes informed consent’s ethical and legal principles, including special considerations for minors and emergencies.
Adverse Events and Device Deficiencies
The guidance also covers the matters associated with reporting adverse events occurring or device deficiencies identified in the course of a clinical investigation. The document additionally emphasizes that all such cases should be subject to vigilant monitoring and timely reporting.
Furthermore, a party responsible for a clinical investigation should take all reasonable steps to foresee and mitigate its associated risks to the greatest possible extent.
Specific Aspects
Apart from the ones mentioned hereinabove, the document also highlights certain specific aspects associated with the clinical investigations, such as:
- Conclusion of an Investigation: the relevant section details the procedures for post-study follow-up, emphasizing the ethical responsibility towards participants, including those who have withdrawn consent or are lost to follow-up.
- Care Beyond Participation: the parties are expected to create necessary arrangements for providing care to participants after their involvement in the investigation ends, focusing on the necessity of such care due to the participant’s participation in the study and detailing the approach to managing this care.
- Policy for Public Disclosure: the document refers to the commitment to registering the clinical investigation in a publicly accessible database, ensuring the results are made publicly available, and outlining the conditions and timeframes for publication.
It also emphasizes the role of the sponsor as a party responsible for a clinical investigation.
Conclusion
The present MDCG guidance provides an extensive overview of the most important regulatory requirements associated with the clinical investigation plan and elements thereof, emphasizing the importance of the steps to be taken to identify and mitigate the risks to ensure the safety of patients while maintaining the accuracy and reliability of the study results.
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