MCC’s Clinical Trial Site Date Entry Study finds there is a lack of agreement on how the industry defines the “data entry complete” time point.
The MCC Industry Practices Insight Report, “Clinical Trial Site Data Entry Study: An examination of how organizations measure site data entry cycle times, performance expectations compared to actual results and site management strategies,” reveals that the “Site Data Entry Cycle Times” metric is very important to organizations but there is no consistency on when data entry is considered complete.
Some organizations define data entry as “complete” when a single data point for the visit has been entered into the Electronic Data Capture (EDC) system, while others define data entry as “complete” when all data for a complete visit have been entered into EDC.
Timely data entry by sites following subject visits is becoming more important with the adoption of the ICH E6 (R2) Addendum and the increasing focus on risk management in clinical trials. Delayed data entry can lead to increased risk to both subjects and the trial.
This study reveals an industry gap could be a significant source of risk unless quickly addressed and a resolution of definition, use, expectation and continuous improvement of this important cycle time metric is needed. Additionally, the study looks at performance expectations compared to actual results and site management strategies.