Work number | Work projects | Main work content |
Clinical trial initiation phase |
|
|
1 | Develop a clinical research plan | Before the start of a clinical trial, the clinical monitor should formulate a scientific, feasible, comprehensive and detailed clinical research plan. include: l Overall schedule of clinical progress; l clinical launch plan;
l Clinical monitoring plan; l Clinical statistics plan; l Clinical summary plan; l Clinical cost budget; l Possible problems and solutions. |
2 | Prepare Researcher's Manual | By reviewing relevant professional literature, clinical monitors are responsible for preparing the investigator's manual. The main contents include: l background information; l Chemical information; l Pharmaceutical information; l pharmacological and toxicological information; l Clinical and comparative drug related information, related literature, etc. |
3 | Choose a clinical unit (Including lead unit) | Visit the proposed clinical units and inspect them: l Cooperative attitude and team spirit; l Personnel qualification, quantity, work experience; l Test sites and beds; l clinical test equipment and equipment; l Daily outpatient quantity. Based on a thorough examination of the above conditions, the lead and clinical participating units were selected. |
4 | Select statistical unit | Learn and verify in detail through multiple channels: l Qualifications of statistical units (professional foundation and staffing composition, etc.); l cooperative attitude; l work efficiency; l Working procedures, etc. Based on a thorough examination of the above conditions, a clinical statistical unit was selected. |
5 | Drafting a clinical protocol And design CRF table (draft) | l The auditors may independently or in conjunction with the main investigator formulate a clinical plan (draft); l The inspector designs the CRF form (draft) based on the clinical plan. |
6 | Convening Clinical Coordination Meeting | l Negotiate with clinical centers to determine when and where the clinical coordination meeting will be held; l Draw up work arrangements and division of labor for meetings; l Prepare relevant materials of the clinical coordinating meeting (technical materials, meeting registration form, preparation of researcher signature proofs, etc.) Hold a coordination meeting and discuss clinical protocols and related issues. |
7 | Revised clinical protocol and CRF form | According to the opinions of the clinical coordinating committee, the supervisor is responsible for revising the clinical protocol and CRF form, and it is determined after the consent of the main investigator. |
8 | Apply for ethics committee approval | Prepare materials for the Ethics Committee meeting, including: l clinical research approval; l Clinical research plan; l CRF table; l Clinical researcher's manual; l Sample of informed consent; l Clinical sample inspection report. After collating and submitting the above materials to the ethics committee of the lead hospital, and paying a certain ethics committee consultation fee, you can apply for the ethics committee to convene a meeting and discuss it. |
9 | SFDA filing | Prepare the following relevant filing materials: l Clinical research plan; l Names of clinical research participating institutions and investigators; l Ethics committee review consent; A sample of informed consent. After the above materials are compiled and submitted, they are submitted to the State Pharmaceutical Administration and the provincial drug regulatory bureau where the clinical units are located for the record. |
10 | Sign a clinical research agreement | The inspector drafted a research agreement with each clinical center, and signed the agreement after the company and the hospital agreed. |
11 | Print official CRF form | The clinical inspector printed and proofread the formal triple carbon-free carbon copy form with the printer. |
12 | Preparation of clinical samples | l Plan the number of clinical samples and packaging according to the type of clinical trial (random or double-blind, etc.); Make plans to buy control drugs; Design sample labels for clinical research of various specifications; l Design packaging boxes of clinical samples of various sizes; l Assist statistical experts to prepare random tables; l Assist statistical experts to blindly edit clinical samples; l Fill in the blind bottom handover record form. |
13 | Distribution of clinical samples | l Distribute clinical drugs to clinical centers and fill in transfer records; l At the same time, hand out clinical researcher's manual, clinical protocol, and formal CRF form. |
14 | Train researchers | l The supervisors convened researchers from each clinical center to train them on relevant pharmaceutical regulations, clinical protocols, and CRF tables; Answer questions from clinical centers. |
15 | Get the centers Normal range of clinical test | l Obtain the normal value range of each center for the clinical laboratory inspections involved in all clinical studies; l Investigate and verify the different normal range of each center; l Submit this normal value range table to the clinical statistical unit. |
16 | Develop recruitment advertisements | If adopted, the inspector shall be responsible for drafting and handling matters related to the posting of advertisements for recruiting subjects. |
Clinical trial stage |
|
|
17 | Develop a visit plan | l Develop a visit schedule; l Develop a CRF form collection plan; Clearly inform the clinical centers of the above plan. |
18 | Clinical quality control | l The inspector monitors the researcher's implementation of the test protocol; confirms that the informed consent of all subjects has been obtained before the test; understands the enrollment rate of the subjects and the progress of the test; l Confirm that all data records and reports are correct and complete, all case report forms are filled in correctly and consistent with the original data; all errors or omissions have been corrected or noted, signed by the researcher and dated; each subject is confirmed All dose changes, treatment changes, concomitant medications, concomitant diseases, missing follow-ups, and omissions were confirmed and recorded; the withdrawal and missed follow-up of the selected subjects were confirmed in the case report form; l Confirm that all adverse events are recorded and serious adverse events are reported and recorded within a specified time; l Verify that the test drugs are supplied, stored, distributed, and recovered in accordance with relevant regulations, and make corresponding records; l Assist researchers to make necessary notifications and applications; l Monitor and record truthfully the follow-ups that the researcher failed to do, the trials that were not performed, the inspections that were not performed, and whether errors and omissions were corrected; l The inspector shall send a written report to the researcher after each visit. The report shall state the date and time of the inspection, the name of the inspector, the findings of the inspection, etc., and archive it. |
19 | Progress adjustment | According to the progress of different hospitals, appropriate case adjustments should be made with the consent of the corresponding clinical center. |
20 | Interim or annual clinical progress report | According to the clinical progress, report to the SFDA the interim or annual clinical progress. |
Clinical Trial Summary Phase |
|
|
twenty one | Recycle CRF Form | The inspector retrieves the CRF form and conducts professional and technical audits. |
twenty two | Unblind | The inspector will work with the main researchers and statisticians to unblind and fill out the unblinded records. |
twenty three | Writing a statistical plan | l The auditors prepare summary summaries independently or together with the main investigator; l Work with statistical experts to prepare and review clinical statistical plans based on clinical trial objectives and summary outlines. |
twenty four | Data Entry | l Statistical experts establish databases; l Auditor audits the database; l The auditors coordinate and monitor the data entry. |
25 | Programming | Statistical experts write statistical calculation programs. |
26 | statistics | l Run statistical procedures, and the inspectors should co-ordinate and solve problems that arise; l For the problems found in statistical inspection, the inspector is responsible for cooperating with researchers to answer questions. |
27 | Statistical Report | l Statistical experts issue statistical reports; l The inspector is responsible for reviewing the statistical report and making specific comments. |
28 | Draft clinical summary and sub-summary | l Clinical monitors draft clinical summaries independently or in collaboration with researchers; The clinical summary is finally reviewed and determined by the investigator. |
29 | Clinical Summary Meeting | l According to the needs, clinical monitors convened researchers and statistical experts in clinical centers to hold clinical summary meetings; l The meeting procedure is the same as the clinical coordination meeting. |
30 | Declaration information completed | l The inspector is responsible for printing and proofreading the finalized clinical summary and binding it to report materials; l Send the final clinical summary to the registration team. |
After the clinical trial |
|
|
31 | Report to ethics committee | l Report the test closure letter to the ethics committee; Report of serious adverse events after the trial |
32 | Test drug destruction | l Record the recovery and storage of test drugs in detail; l Record the destruction method and process of clinical drugs in detail. |
33 | File archive | All documents in clinical trials need to be archived according to GCP requirements, and a designated person is responsible. |
Other jobs |
|
|
34 | Develop Standard Operating Procedures (SOPs) | Each work of clinical research requires the development of standard and detailed written procedures, known as standard operating procedures (SOPs). |
35 | Document management | Strictly follow the principle of "No record, No action", file management for each work involved in the clinic, and store it in accordance with GCP requirements. |
36 | Learning and training | l Study of drug administration regulations; l Professional studies (medicine, pharmacy, statistics, etc.); l Before the clinical start of each project, the clinical monitors need to learn and train the knowledge involved in the project, and can only conduct clinical monitoring of the project after passing the assessment. |
