In order to ensure the quality of the trial, the sponsor and the researcher shall
discuss and formulate the clinical research plan before the trial officially begins. GCP
training was given to the relevant researchers who participated in the experiment. The
research center must manage experimental drugs in accordance with (SOP), including
receipt, storage, distribution and recycling. In accordance with the GCP guidelines,
necessary steps should be taken during the design and implementation phase of the study
to ensure that the data collected are accurate, consistent, complete and credible. All
observed results and abnormal findings in clinical trials should be verified and
recorded in time to ensure the reliability of the data. The instruments, equipment,
reagents and standards used in various examination items in clinical trials should have
strict quality standards and ensure that they work under normal conditions. The
researcher inputs the information required by the program into the eCRF, and the
inspector verifies whether the filling is complete and accurate, and instructs the staff
of the research center to make necessary corrections and supplements. The drug
regulatory department, the institutional review committee (IRB)
/ independent ethics committee (IEC), sponsor inspectors and / or inspectors may conduct
systematic inspections of clinical trial-related activities and documents to evaluate
whether trials are conducted in accordance with the requirements of the study program,
SOP and relevant regulations (e.g. GCP, GMP), and whether trial data are recorded in a
timely, true, accurate and complete manner. The inspection should be carried out by
personnel who are not directly involved in the clinical trial. In order to meet the
audit and / or inspection requirements of the regulator
, the researcher / institution must agree to keep the relevant records, including the
identification numbers of all subjects (sufficient information is linked to the records,
such as eCRF and hospital records), all originally signed informed consent forms. All
eCRF copies, safety report forms, original records, treatment details, related
communication documents (such as letters, meeting minutes, phone reports). Researchers /
institutions are required to keep records in accordance with relevant specifications.
Relevant Chinese regulations and research institutions' requirements for the protection
of subjects' personal information. Authorized representatives and regulatory agencies to
examine (and copy if permitted by law) clinical records for quality review, inspection,
and evaluation of safety, research progress and data validity. Raw data is all the
information necessary to reconstruct and evaluate clinical research and is the original
record of clinical findings, observations or other activities. Examples of these
original documents and data records include, but are not limited to: hospital records,
laboratory records, memos, subject diary cards, pharmacy dispensing records, audio
recordings of consultation meetings, automated instrument records, verified as accurate
and complete copies or transcripts, microfilm, photographic negatives, microfilms or
disks, x-rays and stored in pharmacies participating in the study, documents and records
of subjects in laboratories and medical technology departments.