Validating clinical trial data
For both of these reasons, clinical data quality and integrity are critical.
However, the validation process is complex and dependent on the data captured, business and regulatory concerns, the data management software used, and several other factors, so there are many possible variations and options.
These errors are raised for review to determine if there are errors in the data or if clarifications from the investigator are required.
Another function that the CDMS can perform is the coding of data.
Instead, the regulations and guidances focus on requirements that the data handling systems must meet to ensure data quality and integrity.
Regulations and guidances that do mention clinical data validation, or a part of the process, are listed below.