Friday, November 6, 2009

Monitor the Quality (Data), Monitor the Monitor (CRO)

Pharma Sponsor Data Management as it pertains to Quality Management must regularly assess the quality of the data management process and work at the CRO and request data and metrics to track the quality of the Clinical Study Data. Monitor the Quality and Monitor the Monitors who monitor the quality!

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.
Pharma sponsor DM must review these metrics for any possible trends or inconsistencies in the data.

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.
It is the responsibility of the pharma sponsor DM to review these listings for any possible trends or inconsistencies in the clinical study data. Communication of these findings and any recommendations to the appropriate clinical study team members, for example, CRO, Medical Monitor (Pharma Sponsor), Biostatistician, DM, CRA, CRC, must be immediate and have resolution.

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.

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