Work No. Work Item Main Work Content Clinical Trial Initiation Phase 1. Develop a clinical research plan. Before the clinical trial is initiated, the clinical monitor should formulate a scientific, feasible, comprehensive and detailed clinical research plan. Including:
l Overall clinical schedule;
l Clinical start-up plan;
l Clinical monitoring plan;
l Clinical Statistical plan;
l Clinical summary plan;
l Clinical cost budget;
l Possible problems and solutions. 2. Prepare the Investigator's Manual. The clinical supervisor is responsible for preparing the Investigator's Manual by reviewing relevant professional literature. The main contents include:
l Background information;
l Chemical information;
l Pharmaceutical information;
l Pharmacology and toxicology information;
l Clinical and comparative drug-related information, relevant literature, etc. 3 Select clinical units
(Including the lead unit) Visit each proposed clinical unit and examine its:
l Cooperation attitude and team spirit;
l Personnel qualifications , quantity, work experience;
l Test site, beds;
l Clinical trial inspection instruments and equipment;
l Daily outpatient volume, etc.
On the basis of fully examining the above conditions, the leading and clinical participating units will be selected. 4 Select a statistical unit and learn about and verify it in detail through multiple channels:
l Qualifications of the statistical unit (professional foundation and staffing composition, etc.);
l Cooperation attitude;
l Work efficiency;
l Work procedures, etc.
On the basis of fully examining the above conditions, the clinical statistical unit is selected. 5 Draft the clinical protocol
and design the CRF form (draft) l The monitor independently or together with the principal investigator drafts the clinical protocol (draft);
l The monitor designs the clinical protocol CRF form (draft). 6. Convene a clinical coordination meeting l Negotiate with each clinical center to determine the time and location of the clinical coordination meeting;
l Develop meeting work arrangements and division of labor;
l Prepare relevant materials for the clinical coordination meeting ( Technical information, meeting sign-in sheet, preparation of researcher signature samples, etc.);
l Convene coordination meetings and discuss clinical plans and related issues. 7 Revise the clinical protocol and CRF form. According to the opinions of the clinical coordination committee, the supervisor will be responsible for revising the clinical protocol and CRF form, and determine it with the consent of the principal investigator. 8. Apply for approval by the Ethics Committee and prepare materials for the Ethics Committee meeting, including:
l Clinical research approval document;
l Clinical research protocol;
l CRF form;
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l Clinical Investigator Manual;
l Sample Informed Consent Form;
l Clinical Sample Test Report Form.
Compile and submit the above information to the ethics committee of the leading hospital, and pay a certain ethics committee consultation fee to apply for the ethics committee to convene a meeting and discuss and approve it. 9 SFDA shall prepare the following relevant filing materials for filing:
l Clinical research plan;
l Name of the institution participating in the clinical study and the name of the researcher;
l Ethics committee review Consent form;
l Sample informed consent form.
After compiling the above information, submit it to the State Pharmacy Administration and the provincial Food and Drug Administration where each clinical unit is located for filing. 10 Sign clinical research agreements. The supervisor drafts research agreements with each clinical center and signs them with the consent of both the company and the hospital. 11 Print the official CRF form. The clinical supervisor and the printing manufacturer print and proofread the official triple carbonless copy CRF form.
12 Prepare clinical samples l Plan the quantity and packaging form of clinical samples according to the type of clinical trial (random or double-blind, etc.);
l Make plans to purchase control drugs;
l Design various specifications Sample labels for clinical research;
l Design clinical sample packaging boxes of various sizes;
l Assist statistical experts to prepare random tables;
l Assist statistical experts to Clinical samples are compiled blind;
l Fill in the blind handover record form. 13 Distribute clinical samples l Distribute clinical drugs to each clinical center and fill in the handover record;
l At the same time, distribute clinical investigator manuals, clinical protocols, and official CRF forms. 14 Conduct training for researchers l The supervisors will convene researchers from each clinical center to train them on relevant pharmaceutical regulations, clinical protocols and CRF forms;
l Conduct training on issues raised by each clinical center Answer questions. 15 Obtain the normal value range of clinical testing from each center l The normal value range of each center must be obtained for all clinical laboratory tests involved in clinical research;
l For different normal values ??in each center Investigate and verify the value range;
l Submit this normal value range table to the clinical statistics unit. 16 Drafting advertisements for recruitment of subjects If adopted, the monitor shall be responsible for drafting and handling matters related to the posting of advertisements for recruitment of subjects. Clinical trial ongoing stage 17 Develop a visit plan l Develop a visit schedule;
l Develop a CRF form collection plan;
l Clearly inform each clinical center of the above plan. 18 Clinical quality control l The monitor monitors the researcher's implementation of the trial plan; confirms that informed consent has been obtained from all subjects before the trial; understands the enrollment rate of subjects and the progress of the trial; confirms that the selected subjects The tester is qualified;
l Confirm that all data records and reports are correct and complete, and all case report forms are filled in correctly and consistent with the original data; all errors or omissions have been corrected or noted, and signed by the researcher And indicate the date; confirm that each subject's dosage changes, treatment changes, concomitant medications, concomitant diseases, loss to follow-up, missed examinations, etc. are confirmed and recorded; confirm that the withdrawal and loss of follow-up of the selected subjects have been recorded in the case Explain it in the report form;
l Confirm that all adverse events are recorded, and serious adverse events are reported and recorded within the specified time;
l Verify that the experimental drugs are used in accordance with the Supply, store, distribute, and recover relevant laws and regulations, and make corresponding records;
l Assist researchers with necessary notifications and applications;
l Monitor and truthfully record research Follow-up visits, tests that were not performed, inspections that were not performed, and whether errors and omissions were corrected;
l The inspector must submit a written report after each visit For researchers, the report should state the date and time of the supervision, the name of the supervisor, the findings of the supervision, etc., and keep it on file. 19 Progress adjustment According to the progress of different hospitals, case adjustments are appropriately made with the consent of the corresponding clinical center. 20 Interim or annual clinical progress report According to the clinical progress, report the interim or annual clinical progress to SFDA. Clinical trial summary stage 21. Collect the CRF form. The supervisor collects the CRF form and conducts professional and technical review. 22 Unblinding: The monitor will unblinding together with the main researcher and statistical expert and fill in the unblinding record. 23 Prepare statistical plan l The monitor prepares a summary outline independently or together with the principal investigator;
l Works with statistical experts to prepare and review clinical statistics based on the purpose of the clinical trial and the summary outline Plan. 24 Data entry l Statistical experts establish the database;
l Auditors review the database;
l Auditors collaborate and supervise data entry. 25 Writing Programs Statisticians write programs for statistical calculations. 26 Statistics l Run the statistical program, and the supervisors shall jointly solve the problems that arise;
l For the problems discovered by the statistical tests, the supervisors shall cooperate with the researchers to answer questions.
27 Statistical Report l Statistical experts issue statistical reports;
l Inspectors are responsible for reviewing statistical reports and providing specific opinions. 28 Draft clinical summary and sub-summaries l Clinical supervisors draft clinical summaries independently or in collaboration with researchers;
l The clinical summary is ultimately reviewed and determined by the researcher. 29 Clinical Summary Meeting l As needed, the clinical supervisor will convene researchers and statistical experts from each clinical center to hold a clinical summary meeting;
l The meeting procedures are the same as the clinical coordination meeting. 30 Completion of application materials l The supervisor is responsible for printing and proofreading the final clinical summary and binding it into submission materials;
l Send the final clinical summary to the registration team. After the end of the clinical trial 31 Report to the ethics committee l Report the trial end letter to the ethics committee;
l Report on serious adverse events after the end of the trial 32 Destruction of experimental drugs l Record in detail the recovery and storage of experimental drugs; < /p>
l Detailed records of the destruction methods and processes of clinical drugs. 33 Document archiving All documents in clinical trials must be archived in accordance with GCP requirements, and a dedicated person must be designated to be responsible. Other work 34. Develop standard operating procedures (SOPs). Each work in clinical research requires the development of standard and detailed written procedures, namely standard operating procedures (SOPs). 35 Document Management Strictly follow the principle of "No record, No action", file and manage every work involved in clinical work, and store them in accordance with GCP requirements. 36 Learning and trainingl Study of pharmaceutical regulations;
l Professional study (medicine, pharmacy, statistics, etc.);
l Before the clinical start of each project, clinical supervisors It is necessary to study and train on various knowledge involved in the project, and only after passing the assessment can the clinical supervision of the project be carried out.