Tuesday, November 3, 2009

CRF and DCF Tracking at the Clinical Study Level

The last several blogs pertained to the management of data, discrepancy, quality control, audits, etc., at the Clinical Study Level. This blog pertains to the careful management and tracking of CRFs and DCFs at the Clinical Study Level.

To document data management clinical study progress, while following DM SOPs and WIs, the selected CRO(s) must be required by the sponsor pharma to provide regular metrics reports for CRF and DCF Tracking. The frequency and timing of these reports must be determined on a per study basis.

At a minimum, the following metrics must be tracked for CRFs:
  • Complete CRFs received (all expected visits for the subject received)
  • Total number visits received
  • Total number visits entered
  • Total number reviewed
At a minimum, the following metrics must be tracked for DCFs:
  • Total number generated/sent
  • Total number returned
  • Total number resolved
  • Number of DCFs outstanding greater that "x" days.
A mistake often made: The tracking tool used should not be a excel spreadsheet, spreadsheets can be changed by error, inadvertently and unintentionally by clinical study personnel. These spreadsheets are convenient to use but are not protected from erroneous revision and do not serve as GCP, Good Clinical Practice, accepted "source" documentation.

On scheduled, announced or unannounced "for cause" clinical audits, the use of excel spreadsheets for CRF and DCF tracking purposes will lead to a "failed" audit with serious regulatory, clinical and investigational repercussions.

Tracking records should be collected and versioned in an agreed upon "safe, lock-out" template, final version saved to an archive at the Clinical Study Site, the CRO, at the sponsor pharma, usually placed in the DM folder on the computer hard drive with paper copies to file in the DM department. All agreed upon metrics and tracking tools must be documented in the Sponsor Pharma DMP - the Data Management Plan.

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