The use of technology and workflows in clinical trial quality management (QMS) has been mentioned in the industry, however, few have elaborated on issues management processes, drill-downs, and root cause analysis (RCA) identification.
Good QMSs Identify Failure. Exceptional QMSs Drive Change from Failure. Issues management repository systems (IMRSs) are meant to capture issues, and enable management to aggregate those issues through analytics. Nonetheless, if the IMRS is not designed to ask the right questions (i.e., to fully uncover the root cause of issues and who is responsible for those issues), the system cannot drive productive change; if failures are not identified study teams will continue to operate blindly, and issues will most likely recur.
How to Best Approach Issues Management
As mentioned previously, exceptional QMSs employ IMRSs that identify failure and drive change from those failures. To successfully do that, study teams must efficiently identify issues, diagnose, correct, and resolve them. Figure 1 details this process.
Issues identification: During the issues identification phase, study team members responsible for overseeing study operations, such as a clinical trial or quality manager, will need to log all issues the moment they are identified. The issue could either be small or large in scale and vary in complexity and impact. The manager should identify the responsible party (RP) whom the issue is associated with, such as a monitor or a research coordinator. The manager also needs to log the severity of the issue, whether the issue is critical or not, and its impact on study outcomes.
Example: The monitor, John Smith, did not report a study-specific AE within the company’s policy of 24 hours. This issue severely impacts study outcomes because not properly reporting AEs change study outcomes during data analysis, and can result in federal violations.
Issues Diagnosis: It is very easy to jump to conclusions regarding why certain issues have occurred; if such conclusions are incorrect, the true source of the issue cannot be properly identified, and issues will likely recur. Hence, in the issues diagnosis phase, it is critical to understand that issues can be person-related, process-related, or both. If the issue is person-related, and it is determined that the cause is because the person is not capable of performing the job, the person should be replaced with someone who is capable. Alternatively, if the issue is process-related, the process should be improved. There are also times, when the cause of the issue can be both personally and processed-related.
Process-specific example: John Smith did not report the AE because he did not know; the company’s training omitted to specify SOPs detailing the 24-hour time frame associated with AE reporting. The training should have helped to enforce SOP compliance, but, failed because the training did not contain information regarding AE reporting time frames, resulting in an SOP deviation.
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