NMPA published the “Inspection Checkpoints and Judging Principles for Clinical Trial” for feedback. Feedback needs to be submitted by June 30, 2024.
NMPA announced the “Measures for Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)” on March 12, 2024. These documents will be finalized to apply to the inspection and punishment, carried out by provincial medical products administrations, on the implementation of GCP for medical devices and IVDs.
For an English copy of the Inspection Checkpoints and Judging Principles for Clinical Trial, please email us at info@ChinaMedDevice.com. We charge nominal fees for the translation.
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Key Points for On-Site Inspection of Medical Device Clinical Trials
1. Clinical Trial Conditions and Compliance
Regulation and Approval
- Clinical trials must be conducted in appropriately qualified and registered institutions.
- Approval from the National Medical Products Administration (NMPA) is required for Class III medical devices needing clinical trial approval.
- Main investigators of innovative or Class III medical devices must have senior titles and experience in over three clinical trials.
Institutional Requirements
- Clinical trials must be registered with the provincial drug regulatory authorities.
- Ethical committee approval is mandatory before the trial commences.
Device and Facility Standards
- Devices used in trials must be produced according to quality management standards and must have passed relevant quality inspections.
- Facilities and equipment should be regularly maintained and calibrated.
Researcher Qualifications
- Researchers should have appropriate professional qualifications and training.
- They must undergo specific training related to the clinical trial protocol and device usage.
Contracts and Documentation
- Contracts between sponsors, institutions, and researchers should clearly define roles and responsibilities.
- Sponsors should provide all necessary documentation and devices for the trial.
2. Protection of Subject Rights
Ethical Review
- Ethical review processes and documentation must comply with relevant regulations and standards.
- The ethical committee should retain comprehensive records and review any protocol amendments.
Informed Consent
- Informed consent must meet GCP and regulatory requirements.
- Subjects or their guardians must sign the latest version of the informed consent document before participation.
- Any updates to the informed consent must be reapproved and re-signed by the affected subjects.
3. Clinical Trial Protocol
Protocol Adherence
- The trial protocol should be signed and dated by the main investigator and approved by the institution.
- All centers in multi-center trials must follow the same protocol version.
Protocol Deviations
- Any deviations from the protocol must be reported to the ethical committee.
4. Implementation of the Clinical Trial
Subject Enrollment
- Accurate records of subject screening and enrollment must be maintained.
- Subject identification documents must be preserved.
- Enrollment should comply with the protocol’s inclusion and exclusion criteria.
Trial Execution
- Procedures and follow-ups must adhere to the trial protocol.
- Any deviations must be reported to the ethical committee.
- Adverse events should be promptly treated and documented.
5. Data Recording, Traceability, and Reporting
Data Integrity
- All observations and findings must be accurately and completely recorded.
- Data should be real, accurate, complete, and traceable.
Documentation Standards
- Source data and clinical trial records should be clear and unmodifiable.
- Any required modifications must be justified and properly documented.
Electronic Data Systems
- Electronic data systems should have robust validation, access control, and audit trails.
- The systems should enable data traceability to the origin.
6. Management of Trial Devices
Device Usage and Records
- Trial devices should be used exclusively for trial subjects.
- Records of device use, including control devices, must be maintained.
Consistency with Documentation
- Device details such as name, model, and specifications must match the trial protocol and other documentation.
Storage and Information
- Device storage records must include comprehensive details such as name, model, batch number, and manufacturer.
Takeaways from the Clinical Trial Institutions Measures
The “Measures for Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)”, issued on March 12, 2024, stated that:
- Different types of inspections can be combined：
- Routine Supervisory Inspections occur annually to assess if testing institutions meet registration requirements and comply with quality management standards for medical device clinical trials. They prioritize risk, focusing on the institution’s ongoing clinical trial projects, especially during initial post-registration inspections.
- Cause-Driven Inspections target specific quality and safety risks or significant allegations of violations, allowing unannounced visits to investigate potential issues.
- Other inspections, like special or random spot checks, supplement above approaches to ensure compliance and quality standards are maintained in testing institutions.
- The following circumstances should be prioritized or have increased inspection frequency:
- Authenticity issues or serious defects are found within 2 years
- Non-compliance conclusion is reached within 2 years
- Principal investigator undertakes a large number of clinical trial projects at the same time, the principal investigator’s management capabilities or the number of researchers are relatively insufficient
- Complaints, reports or other clues indicating the existence of quality and safety risks;
- Other indications that the trial institution may have quality management risks, such as: clinical trials have not been carried out for more than one year and trials are subsequently resumed.
- The inspection process primarily involves on-site inspections, with remote inspections conducted when necessary.
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- Source: https://chinameddevice.com/clinical-trial-inspection-2/
