QRTI Newsline --- Wednesday September 8, 2010

The Benefits of System Audits for Clinical Data Verification

By Phyllis B. Kent

Every company wrestles with the fact that they cannot audit all of the data necessary to feel confident in a regulatory submission. The Quality Management Plan based upon a single study may become impossible to carry out when a submission contains many protocols because of the limited resources in the Clinical Quality Assurance Department. When a company reaches this point, it is time to implement Systems Audits to streamline the amount of auditing required for each study.

Systems audits are a method to assess the entire clinical data handling process. If the process is in control, then the data passing through the process will be in control, thus eliminating the need for extensive data verification for each submission. System audits offer the benefit of assessing the process in real time verses a retrospective audit at the time of regulatory submission. They offer the option for process improvement as the audits are done concurrently with the studies and corrections can be implemented immediately.

In order to be effective, the systems audits must be comprehensive. We cannot validate the data entry process without first validating the data. Similarly, we can not audit a Clinical Summary Report without first validating that the data capture, entry and analysis has been properly executed.

The audits must cover each component of the Clinical Data Management system. These components are:

• raw data validity
  
  
• CRF accuracy and completeness
  
  
• data entry accuracy and completeness
  
  
• data analysis validity
  
  
• Clinical Summary Reports (CSR) accuracy & validity
  
  

The system audits examine the quality control of each of these steps to assure that the control checks are being performed and the results meet the standards set. When the audit validates that each of these steps are being performed accurately and in conformance with the requirements, we can be assured of valid data.

The benefits of auditing the system instead of a submission are many. First, the audits are done while the data is being collected and processed. This permits in process correction and optimization of procedures. Second, any data passing through the validated system is valid. Each study does not have to be audited. Third, the audits are not in the timeline for submission. They are performed concurrently with the study and are not a retrospective check once the database is completed. There is no need to hold up the analysis or report preparation while waiting for QA to verify the database. The final CSR is reviewed for conformance to the standards, for accuracy and completeness. This final piece of the system audit gives management the assurance that the submission accurately reflects the data captured at the sites. Management can be confident that the system has produced a high quality CSR.

© 2010 Quality Research Training Institute