1. Approval from ethics committee and drug supervision and administration department

Any approval or consent from ethics committee must be in written form and include necessary information. This document must be kept by the researcher in the research file. In addition, researchers had better keep a list of members of the ethics committee and ensure that the minimum number of ethics committee members required by law attended the examination and approval meeting.

during the research, all correspondence and materials with the ethics Committee (including the modification of the experimental scheme or informed consent, SAE reports, etc.) shall be recorded and kept. Some ethics committees may require researchers to submit an annual report on the experiment. At the end or termination of the experiment, the Ethics Committee shall be informed, and a copy of the letter shall be kept in the research file. In addition, the ethics committee may also ask the researcher to provide a summary report, which should also be recorded after it is provided.

The laws and regulations of China and many other countries require that the clinical research of drugs must be approved in writing by the supervision and administration department. In addition to the sponsor's keeping the original of the document, the ethics Committee and researchers should keep a copy in their files.

2. List of researchers and resumes

Researchers must keep a list of participants in clinical trials (including any managers who have conducted clinical evaluation, filled in CRF, carried out informed consent, managed documents, and experimented with drugs, etc.) and the latest CV of each researcher signed and dated by himself.

the list of researchers should indicate the responsibilities of each person and the date when they participated in the experiment (see the example in table 12. 1). In addition, the personnel who perform informed consent and fill in CRF should also leave samples of signatures and initials in this document to ensure that only authorized personnel can undertake these two tasks.

A researcher's resume should at least include the following contents: name, education background, degree, professional title, on-the-job or off-the-job training after graduation, work experience, information indicating his research level in this field, such as published articles or works, research projects he participated in in in the past, and so on. In addition, you should also indicate whether you are familiar with GCP, GCP training or seminars you have attended, etc. The function of resume is to prove that each researcher is suitable for or has the ability and qualification to engage in the corresponding work in clinical trials.

when new people participate in a trial, even if it is only short-term or temporary, the personnel list and resume files should be supplemented and updated.

3. Laboratory records

Two types of documents must be kept for the research that requires the laboratory to participate in the measurement and evaluation: first, the normal reference range of the measurement project, and researchers should generally keep one copy of this document; Second, the laboratory operating procedures. Some countries may also require laboratories conducting clinical tests to be certified by GLP or other forms of quality system certification or evaluation. These certification or evaluation documents generally do not need to be kept by researchers, but the laboratory should keep these documents and be prepared to be inspected by inspectors, inspectors or inspectors.

some experimental projects may need to keep blood or other body fluid samples for later analysis or repeated determination. These samples must be recorded. For convenience, each sample is generally assigned a unique code or barcode, and then a list of identification codes (subjects, sampling date, etc.) is kept.

4. Records of experimental drugs

The researcher shall keep records of the receipt, preservation, distribution, use by subjects, recovery and return of the remaining drugs to the sponsor or destruction according to the agreement between the two parties. The basic principle of experimental drug counting management is to achieve a balance between collection, use, storage and recovery. If there is any discrepancy, it is necessary to find and record the reasons.

The unqualified records of experimental drugs are the main problems found in many foreign clinical studies. In China, the management and counting of experimental drugs is also one of the main weak links. Relevant personnel should strengthen their understanding of the counting and recording of experimental drugs.

2. trial monitoring report before the start of clinical trial, during the trial and at the end of the trial, the supervisor should visit and monitor the research institution to determine whether the research conditions and personnel are all ready, the trial is conducted in strict accordance with the research plan, GCP and SOPs, the subjects are protected, all the data filled in CRF are consistent and complete with the original data, and all the adverse events are recorded and serious adverse events. The inspector will submit an inspection report to the applicant after each visit. The researcher should keep a copy of the report.

1. Subjects screening table, selection table and code table

In some experimental projects, it may be necessary to screen a large number of patients first to determine the patients who meet the selection conditions. For example, in the research of a new drug to reduce blood lipid, measuring the level of blood lipid will be one of the necessary steps in screening, and only those patients whose blood lipid level is higher than the predetermined standard can participate in the trial. The researcher should keep a record of each screened patient.

This record generally adopts a pre-established form, which is filled in for each patient who participated in the screening, and is bound and filed by the researcher after the screening. The candidate list of subjects is a document that records the test numbers of subjects in chronological order. Subject identification code table is a confidential document kept by researchers, which records the names of subjects and the codes assigned when selecting candidates, so that researchers can identify subjects in time according to their codes when necessary. These two documents are important documents that researchers must keep, and they must be carefully filed and kept, and must not be lost or destroyed.

2. data query and correction form

after the examiner takes CRF away, he may sometimes return a data query form, DQF) or data clarificationform, DCF) to the researcher, which lists the data or problems that need further verification. Generally, the contents in CRF will be questioned under the following circumstances: some data are missing, such as the start or end date is not filled in; Unreasonable data, such as the end date is earlier than the start date, and the medication time is before the informed consent form is signed; Serious abnormal or unreasonable data, such as the subject's systolic blood pressure of 234mmHg; Unclear handwriting, unable to identify the data filled in; For coding problems, such as recorded adverse events or accompanying diseases without medical terms, these data cannot be coded in the database. After receiving the data query (or correction), the researcher should approve and fill in the approval results one by one, sign and date them, and return them to the applicant in time so that they can correct the data records or add them to the database. Researchers should keep copies of data query forms and correction forms.

3. Records of adverse events and reports

According to the requirements of GCP, regardless of whether the adverse events have a causal relationship with the experimental drugs, researchers should record them in the original records and fill them in CRF. Adverse events also include the increase in the frequency and severity of onset before and after the subjects entered the trial. Adverse event records at least include:

1. Description of adverse events;

2. time of occurrence;

3. End time;

4. severity and frequency;

5. Whether treatment is needed, and if so, the record of treatment and effect;

6. the causal relationship between adverse events and experimental drugs;

7. tracking of adverse events, etc.

all medical documents related to adverse events should be recorded in the original documents, including laboratory sheets, electrocardiogram, test results reports, etc. Serious adverse events should be reported to the applicant, drug supervision and administration department, ethics committee and other cooperative researchers in time. All these situations should be recorded and kept.