Quality metrics may include:
- frequency of edit checks
- number of data changes due to data entry error, obvious error and DCF
- these metrics can be broken down by database and/or clinical study site.
Where can potential issues be found:
- edit check programming
- data entry
- CRF design
- data being provided by the clinical study site
- listings of key clinical study efficacy data
- listings of key clinical study safety data
- CRO data entry rules
- CRO data review rules
- data being provided by the CRO.
Monitor the quality of your data, ensure use of the DMP and QMP, monitor the monitor, the CRA, the CRO, ensure there is verbal communication as well as written metrics and listings providing data, potential trends and inconsistencies. Once found, the action is immediate - correct and assess the impact on clinical study data quality, data error %, resource and capacity to correct.
Most important, communicate the issue(s) to the team, re-train the team pertaining to appropriate use and adherence to relevant SOP, WI, QMP and DMP and check to see if there is a change in clinical study site personnel.