Key points of on-site inspection of in vitro diagnostic reagents in clinical trials

2021-06-18

On-site inspection points for clinical trials of IVD are formulated according to the Regulations on the Supervision and Administration of Medical Devices, Measures for the Registration and Administration of IVD, Technical Guiding Principles for Clinical Trials (Research) of IVD and other relevant requirements. The specific inspection points are as follows:

Serial Number	Key points of on-site inspection
1	Clinical trial conditions and compliance
1.1	Clinical trial institution
1.1.1	Whether it is a provincial medical and health unit, in vitro diagnostic reagents for special purposes can be carried out in municipal disease prevention and control centers, specialized hospitals or inspection and quarantine institutions, drug rehabilitation centers and other units.
1.1.2	Whether there are professional and technical personnel, instruments and equipment suitable for the test of IVD reagents, sites, etc.
1.1.3	Whether the instrument and equipment have usage records and whether the usage records are consistent with clinical trials.
1.2	Ethical review of clinical trials.
1.2.1	Whether the informed consent meets relevant requirements (objectively impossible to obtain the subject’s informed consent, the subject’s informed consent can be exempted after review and approval by the ethics committee.
1.2.2	Whether there are ethical review documents.
1.2.3	Whether the ethics committee maintains the reviewed documents, and whether the version and content of the reviewed protocol/informed consent are consistent with the version and content of the implemented protocol.
1.3	Clinical trial filing status.
1.3.1	Whether to submit the record to the provincial Food and Drug Administration in accordance with the regulations.
1.4	Clinical trial agreements/contracts
1.4.1	Whether clinical trial agreement/contract is signed.
1.4.2	Whether the content of the agreement/contract is consistent with the IVD information for the test.
1.4.3	Whether to formulate documents to clarify the division of responsibilities of all parties.
2.	Clinical Trial Section
2.1	Preparation of clinical trials
2.1.1	Whether the applicant has consulted with various clinical trial institutions to develop a unified clinical trial protocol.
2.1.2	Whether the clinical trial and its modifications have been reviewed, approved or documented by ethics committee .
2.1.3	Whether the reviewer formulates standard operating procedures according to the clinical trial project, and conducts training on the clinical trial project and the use of IVD for all investigators participating in the trial, and whether there are training records.
2.1.4	Whether the clinical trial institution has a record of the transfer of IVD and related documentation.
2.2	Informed consent status (except for exempted informed consent).
2.2.1	Whether the number of signed informed consents matches the number of cases reported in the clinical trial (including screening failures).
2.2.2	Whether the number of signed informed consent versions is consistent with the version approved by the ethical review.
2.2.3	Whether the ethical review time is earlier than the signing time of the informed consent.
2.2.4	Whether the signed content of the informed consent is complete and standard (including the telephone number of the clinical trial personnel, the date of signing, etc.).
2.2.5	Whether the informed consent signed by the subject or its legal representative (verify the actual situation of the subject’s participation in the trial if necessary).
2.3	Implementation status of clinical trials.
2.3.1	Whether the applicant and the clinical trial staff conduct the pre-test of the clinical trial, and whether the clinical trial staff master the instruments, operation methods, technical performance, etc. applicable to the IVD for the test.
2.3.2	Whether the clinical trial procedure follow the clinical trial protocol.
2.3.3	Whether the protocols performed by each clinical trial facility are consistent.
2.3.4	Whether the original data collection, case report forms (if applicable) of the clinical trial were signed by the clinical trial personnel.
2.3.5	Whether the statistical analysis of clinical trials is completed by the personnel specified in the trial plan in accordance with the specified methods.
2.3.6	Whether the applicant implements supervision of clinical trials, and whether there are supervision records.
3.	Clinical trial data management
3.1	Whether there is a record of case screening and case identification documents (if applicable).
3.2	Whether the number of cases screened, selected, and completed in the inclusion records and case identification documents (if applicable) is consistent with the information in the clinical trial report.
3.3	Whether the case screening records and subject identification documents (if applicable) are traceable and relevant.
3.4	Whether the test report generated in the test or the data in the result can be traced to the source.
3.5	Whether the content filled in the case report form is traceable in the original medical records, inspection records and other original records (if applicable).
3.6	Whether the case report form is complete (if applicable).
3.7	Whether all the test data in the clinical trial are signed by the test operator and reviewer and sealed by the test organization.
4.	Management of IVD for test
4.1	Whether the product has a qualified product inspection report issued by a qualified testing agency.
4.2	Whether the management records (including transportation, receiving, processing, storage, distribution, recovery and destruction, etc.) are complete and whether the quantity is consistent.
4.3	Whether the transportation conditions, storage temperature, storage conditions, storage time and safety validity period meet the requirements.
4.4	Whether it is consistent with the product name, specification and model in the test report and clinical trial report.
5.	Management of clinical trial samples
5.1	Whether there are original records of the source, number, preservation, use, retention and destruction of clinical trial samples.
5.2	Whether the version and content of the clinical trial report applied for registration are consistent with the version and content kept by the clinical trial institution.
5.3	Whether the data in the clinical trial report applied for registration are consistent with the original records and original data kept by the clinical trial institution.
5.4	Whether the signature of the clinical trial personnel and the signature of the clinical trial institution in the clinical trial report of the registration application are true.

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