NMPA issued the “Key Points and Principles for Medical Device Clinical Trial Inspections (Draft) on November 28, 2023. Feedback needs to be submitted by December 31, 2023.

It proposed to stipulate on Conditions and Compliance, Protection of Subject Rights, Protocol, Implementation, Traceability and Reporting, and Devices Management of Clinical Trial. Among them, the Implementation is divided into three parts: Subject Screening and Enrollment, Execution of Clinical Trial Protocol, and Processing and Reporting of Safety Information.

The document also regulates the clinical trial inspection for IVDs. For an English copy of the document, please email info@ChinaMedDevice.com. We charge a nominal fee for the translation.

During NMPA on-site inspections, many clinical trials were found to have compliance issues. Click HERE to read the news.

Inspection Key Points

The document, in tabular format, outlines the aspects for compliance, ethical considerations, subject rights protection, traceable implementation and information management.

Clinical Trial Conditions and Compliance:

• Emphasizes proper documentation and registration of the clinical trial institution.
• Requires approval from the NMPA for Class III medical devices.
• Stresses the significance of involving experienced researchers, especially for innovative medical devices.

Clinical Trial Record Keeping and Approvals:

• Highlights the importance of obtaining approval from the ethics committee.
• Specifies the signing of the clinical trial contract between the sponsor, institution, and principal investigator.
• Outlines the requirement for providing relevant trial documents before the trial starts.

Quality Management of Trial Medical Devices:

• Emphasizes adherence to quality management system requirements for trial medical devices.
• Includes inspection points for compliance, product inspection reports, and maintenance of trial-related instruments.

Researcher Qualifications and Training:

• Stresses the necessity of professional qualifications, training experiences, and relevant expertise.
• Expects researchers to undergo training on the trial’s protocol and the use/maintenance of trial medical devices.

Subject Rights Protection:

• Emphasizes the role of ethical review committees in ensuring GCP, regulations, and SOP compliance.
• Highlights the importance of thorough ethical review documentation and updated informed consent forms.
• Scrutinizes the timing of informed consent, ethical approval, and subject screening for proper sequencing.

Clinical Trial Protocol:

• Stresses the importance of a signed and dated protocol by the principal investigator and the institutional review.
• Emphasizes compliance with the latest version of the approved clinical trial protocol.
• Highlights consistency in the version of trial protocols across multiple centers in multicenter trials.

Subject Screening and Enrollment:

• Review and verify case selection and enrollment records.
• Confirm alignment of case selection with trial protocol criteria.
• Document reasons for subject screening failures.
• Ensure subject identification information in screening documents.
• Adhere to randomization procedures specified in the trial protocol.
• Confirm subject eligibility based on inclusion/exclusion criteria.
• Verify compliance with the trial protocol through hospital systems.
• Document sufficient supportive evidence for subject inclusion.

Execution of Clinical Trial Protocol:

• Ensure trial procedures align with the protocol within specified timelines.
• Report deviations from the clinical trial protocol to the ethics committee.
• Document and explain subject withdrawals or lost follow-ups.
• Adhere to safety and efficacy evaluation methods as per the protocol.
• Record and report concomitant drug/device use, treatments, and therapies.
• Implement and document blinding procedures if applicable.
• Conduct monitoring by trial inspectors and address identified issues promptly.

Safety Information Handling and Reporting:

• Hold the researcher responsible for clinical decisions related to the trial.
• Verify and cross-check abnormal laboratory results outside acceptable ranges.
• Ensure timely and adequate treatment for adverse events and serious adverse events.
• Record adverse events, serious adverse events, and device defects.
• Report serious adverse events to relevant authorities within 24 hours.
• Report trial-related serious adverse events promptly to ethics committees.
• Halt or terminate the trial if risks outweigh benefits and report to authorities.

Clinical Data Recording, Traceability, and Reporting:

• Record all observations and findings accurately and comprehensively.
• Maintain true, accurate, and traceable clinical trial data.
• Include clinical trial-related medical records in patient records.
• Ensure electronic data collection systems are validated and secure.
• Trace and cross-verify information across case report forms and databases.
• Confirm consistency in trial reports across various documentation.
• Abide by the Standard Operating Procedure for database locking.

Management of Trial:

• Restrict the use of trial medical devices to enrolled subjects only.
• Document the use of trial and control medical devices.
• Verify consistency in product names, specifications, and usage instructions.
• Record device information, including name, model, batch, and serial numbers.
• Maintain records of device transportation, receipt, storage, distribution, and disposal.
• Ensure compliance with specified transportation and storage conditions.
• Confirm that the recorded device quantities align with sponsor-provided data.
• Document the storage and usage of special medical devices in line with trial requirements.

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• Source: https://chinameddevice.com/clinical-trial-inspection-key-points/