Finding a Needle in a Haystack
Based on information provided by study staff to a sponsor, the Practical Solutions Group, LLC was asked to investigate potentially unauthorized access (e.g., improper permissions, unauthorized data entries) to the study database maintained by a CRO. Additionally, the sponsor wanted us to investigate why the system did not flag visits during which safety data should have been collected but was not. The sponsor cast a disapproving eye on the CRO, believing that these issues were caused by ineffective study/system-related procedures at the CRO – or worse. The biggest challenge of getting to the bottom of the issues (needle) was the vastness of scope of the information that to be assessed (haystack): 1) over 40 individuals who had or previously had system access; 2) approximately 10 sites; and, 3) study and administrative activities that spanned a timeframe of more than 5 years.
Based on information received from the sponsor regarding system access and data entries, we constructed approximately 30 audit trail-based queries to identify who did what and when they did it. More than half of these queries were developed “on the spot” based on documentation provided by the CRO and interviews with key CRO project-related and technical management and staff.
Based on the results returned, review of related documentation and discussion with the CRO’s staff, we concluded the following:
- There were no unauthorized system accesses or unauthorized data entries; the information the sponsor received from the study coordinator regarding the system access and data entries was false.
- Safety data was not collected when it should have been because the sponsor did not properly specify such a requirement for a custom alert.
- The CRO is a reliable business partner.
So what was accomplished after 2 days on site at the CRO? The sponsor was reassured that the security and integrity of the study data was not compromised, and trust regarding the CRO’s support was re-established. A most positive outcome to a complex issue!