What is a query in the clinical trial process? A query is a tool used to communicate a discrepancy/inconsistency in data found by a person (usually from a sponsor or a representative) or by software that is then forwarded to the trial site staff to get further clarification or resolution. Queries may be formed during system/auto checks, source data verification, or clinical monitoring visits.

Why are queries important?

Queries ensure are important tools in the clinical trial process as they:

  • Ensure compliance with protocol.
  • Assess trial data quality.
  • Ensure data validity.
  • Ensure data completion.
  • Prevent further errors.
  • Allow for successful audits.

Source: Ness, E. Clinical Data Management [Slides]. NIH National Cancer Institute. https://ccrod.cancer.gov/confluence/download/attachments/71041052/CDM.pdf