Validating clinical trial data
Adverse event data is a bit more difficult to manage, and therefore there may be more value associated with SDR than the basic data transcription checks performed by SDV..
All Source Data Checks Are Not Equal The guidance that will be forthcoming from Trans Celerate and Medidata will hopefully help to shape the industry in regard to SDV and SDR.
Trans Celerate approached Medidata with some specific ideas, and Given notes the Medidata team helped reshape the analysis parameters based on what might be most interesting to the study. “First, we looked at the specific impact of SDV on the total number of changes made to data entered into the case-report form.For instance, are self-reported adverse events from the subjects themselves easier for sites to capture accurately versus diagnostic events?” RBM: Not As Difficult As It Seems For sponsors, the results should spur some internal discussions, especially around the topic of RBM.Basically, the site should have entered it, they didn’t enter it, SDR occurred, and then the adverse event data was entered after SDR occurred.
We wanted to determine whether there is a higher percentage of data that’s missing but gets entered through SDR.” The team did find a higher percentage in adverse events.
“There are multiple sources of data, such as lab science and clinical science systems, which can create an adverse event.