Clinical research audit: raw materials from “verification” to “audit”

Medical Network November 21st, the original data verification (SDV) has always been an important means to ensure the quality of clinical research, and it is also the place where the auditor spends the most time and energy in the clinical research and monitoring process. However, with the continuous accumulation of clinical research experience of the sponsors and researchers, and the continuous emergence of new tools for clinical research, 100% of the original data verification can no longer meet the requirements of high quality and high efficiency in clinical research and supervision.
With the introduction of the US FDA's risk-based clinical research guidelines, the Source Document Review (SDF) has received increasing attention from clinical research departments.
SDV has become more and more serious, and the cart before the horse is upside down.
In the past two decades, with the continuous development of clinical research specialization, the division of labor of auditors has become more and more detailed. This highly differentiated, close-knit streamlined operation has greatly improved the quality and efficiency of clinical research and supervision, but it has also produced some drawbacks.
For example, because the auditor is only responsible for the verification of the original data, each company also determines the workload of the auditor according to the amount of data to be verified. Some professional companies need to verify the workload of a single pathology report in terms of calculating the workload. How many minutes? Under this circumstance, after many auditors go to the clinical research center, they can only check whether the original medical records of the patients are consistent with the data of the pathological report form, and there is no time to take care of others.
This kind of mechanical checkup also led to a decline in the professional background requirements of the auditors. A few years ago, clinical research monitors needed a certain medical background; in recent years, people have found that people without medical background can do the kind of mechanical check.
With the continuous improvement of clinical research level, the increase of researchers' experience, and the participation of professional clinical research coordinators, the incidence of errors in pathological report forms is becoming less and less. Sometimes the monitor went to a well-managed clinical research center, and after a day of careful inspection of the original data, almost no errors were found. This sometimes made some monitors feel overwhelmed. They couldn't be sure that they didn't find the problem, or they didn't have a problem. So they found some trivial problems and wrote them in the report. Although the reported problems are often not necessarily related to the quality of clinical research, they also lead to extreme trends in the clinical research industry.
SDF regression clinical research focus
Under this circumstance, the US FDA timely launched a risk-based clinical research audit, and ICH E6 R2 was also introduced, which will focus on the quality control of clinical research to the protection of subject rights and the reliability of clinical research results. Two aspects. In this situation, the original data review (SDF) will gradually replace the original data verification (SDV), which becomes the main content of the auditor's clinical research and supervision work.
Source Data Review (SDF) is the inspection of a patient's original data at the Clinical Research Center. In fact, this should be part of the original data verification (SDV), because it is necessary to compare the data on the original data with the data in the case report form. However, in the actual work of the auditors, the workload pressure and other reasons, the monitors spend less and less time reviewing the original medical records, and spend more time checking the data, which actually It is the end of the cart. Although some experienced project managers have always emphasized the importance of viewing the original materials, the auditors did not necessarily follow the actual work, because 100% of the SDV is a hard indicator for the assessment monitor.
After the introduction of the FDA's risk-based clinical research guidelines, the importance of 100% original data verification is no longer emphasized, and the auditors have the energy to refocus their work on the original data review.
The original data review (SDF) is to look at the subject's original medical record and not to check the case report form, because the error in the case report form is not the main error in clinical research. Many of the problems found in the original data review, such as potential program violations, underreported adverse events, undocumented concomitant medications or concomitant diseases , wrong dispensing and medication methods, are often directly related to the reliability of clinical findings. It is also related to the safety of the subjects and is the most concerned place in clinical research.
In summary, the auditor comprehensively checks the subject's medical history during the audit process, understands the actual situation of the subject in the clinical study, and comprehensively responds to the subject's compliance, treatment response, and drug safety. Grasping is the focus of future audit work.

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