(I) Preparation stage
Obtain qualified inspection reports (within one year) from nationally accredited medical device inspection centers and qualification documents from the sponsor.
Prepare sufficient test medical devices that meet the relevant requirements of the applicable medical device quality management system.
Screening of clinical trial organizations.
The sponsor discusses the formulation of the clinical trial protocol, the preparation of the trial process, the writing of the first draft of the informed consent form, and the design of the CRF.
The preliminary clinical trial protocol and CRF are sent to the statistics department, which considers whether the protocol meets the statistical requirements and calculates the number of trial cases.
Training sessions are held within the company to learn about GCP and related regulations. Clinical trial protocols, informed consent forms, CRFs, etc. are discussed to determine the trial process.
After the clinical trial protocol is agreed upon again, the principal investigator should sign on the clinical trial protocol to recognize and implement this protocol without modification.
The sponsor determines the clinical supervisor.
Declare the ethics committee for approval and sign the clinical trial agreement with the institution.
The sponsor provides test articles and necessary items for the trial (e.g., emergency envelopes, CRFs, informed consent forms, and various related documents).
The clinical trial organization assigns a person responsible for the management of test articles and items, and is responsible for the registration, preservation, issuance, recovery, etc.
Recorded with the provincial food and drug supervision and management department where the sponsor is located.
(ii) implementation stage
Center start: all participating researchers must be familiar with and strictly implement the clinical trial program. Must be familiar with the performance of the test device, receive training in the operation and use, once the occurrence of adverse events can quickly take measures.
Case screening: ICF was signed and subjects were screened in chronological order of patients. Screening qualified subjects in accordance with the chronological order of enrollment issued device random number.
Diagnosis and treatment: the two groups, the test group and the control group, entered the diagnosis and treatment phase.
Visit observation: physical characteristics, past medical history, safety and efficacy indicators, device performance evaluation indicators.
AE/SAE record report: record time limit, medical treatment measures, reporting process, reporting scope.
Data recording: timely, standardized, true and reliable.
Emergency blinding: when serious adverse events occur and the group has to be clarified, the investigator should notify the sponsor/supervisor, the ethics committee and the management of the institution in time, and record in detail the reasons for blinding and the treatment process before blinding.
Discontinuation of the trial: subjects, the sponsor, and the ethics committee must be notified, and the reasons must be clarified.
Protocol modification: Individuals are not allowed to arbitrarily modify the clinical trial protocol during the implementation of the trial; any modification should be agreed by the sponsor and approved/recorded by the ethics committee.
On-site monitoring: on-site monitoring shall be conducted according to the proposed monitoring plan.
(3) Summarization stage
Endpoint monitoring: trial documents, ethical issues, project completion, AE/SAE, trial data, trial operation procedures, researcher changes, trial filing, and trial costs.
Data management: Supervisors must supervise the management and collection of any data generated during the entire trial to ensure the authenticity, completeness and reliability of data collection. The end point of the supervision of the test data to determine the correctness, delivered to the statistical department.
Data Audit: Data must be audited before and after entry. Including the researcher's audit, the monitor's audit, the entry operator's audit, the data manager's audit.
Data query: data administrator sends data query, supervisor transfers query data, researcher answers query data.
Blinded audit: audit of blinded execution of double-blind clinical trials.
Locked library analysis: statisticians perform data analysis to produce statistical reports.
Summary report.