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.
