Resolving queries: investigation, correction, and explanation
Execute systematic query resolution, write effective responses, route queries to investigators when needed, and handle queries that reveal actual data errors.
The query that should have taken two minutes
A query appears in the EDC: "Verify systolic blood pressure of 210 mmHg at Visit 4. Value exceeds protocol-defined range." The coordinator glances at the field, types "Verified, data correct," and closes the query. Thirty seconds of work. The monitor reopens it two days later: "Please provide source documentation supporting systolic BP of 210 mmHg. If correct, describe clinical context and any actions taken." The coordinator checks the source document for the first time and discovers the actual recorded value was 120 mmHg. A transcription error -- the 1 and 2 were transposed. What should have been a simple correction on the first exchange is now a three-step process: correct the CRF, respond to the reopened query with an explanation of the error, and answer for why the original response said "verified" when no verification occurred.