All clinical data managers (CDMs) are familiar with the difficulties of ensuring that laboratory values are compared to the local laboratory normal ranges that were valid at the time of the measurement. In studies with many local laboratories, and in global studies, the same test may be reported in different units across the study. To help alleviate these problems, some studies use central laboratories. Yet there are some problems with this approach as well. Shipping samples from study sites to the central laboratory incurs extra cost and runs the risk that the sample will be unusable when it arrives.
Medidata Rave® Lab Administration is a tool for CDMs that makes local laboratory data management more efficient and accurate. It flags out-of-range values based on the normal range of the local laboratory from which that value came and converts all ranges and laboratory values across sites to a standard unit.
At the start of a project, the CDM creates a standard conventions document that contains the technical system requirements, a description of the analytes to be collected, the normal ranges of each local laboratory, the scope of the data review for the project, and the schedule of review. As the study progresses, the CDM loads updated normal ranges provided by the clinical team directly into Rave Lab Administration. The system compares ranges, values and dates, eliminating the need for laboratory data edit checks.
There are advantages for study site staff. Data entry time at the site is shortened because staff do not need to enter or update normal ranges. When a laboratory value is entered into the eCRF, the system automatically flags an abnormal value and site staff can immediately determine whether the abnormality is or is not clinically significant.
PROMETRIKA’s CDMs have incorporated Rave Lab Administration into more than half-a-dozen recent database builds and are already experiencing improvements in workflow. Database developers can configure the system once for a particular sponsor and that configuration can be used across that sponsor’s studies. Rave Lab Administration can apply normal ranges specific to gender and/or age, eliminating the need for edit checks. Automatic conversion of values makes the laboratory data immediately ready for statistical analysis. CDMs are pleased with the added value Rave Lab Administration brings to managing laboratory data.