About Partial Source Data Verification

To ensure that all of the data collected during the clinical trial is complete, accurate, and verifiable, companies use SDV (source data verification). This key process involves many on-site visits and verification of all the data in the CRF (case report form).

The number of clinical trials is growing, and these trials are becoming more complex. Also, regulatory agencies are more closely monitoring the drug approval process. Consequently, the cost of these trials is drastically rising, and companies and CROs (clinical research organizations) face challenges in keeping budget and time issues for trials under control. Consequently, more companies and CROs are adopting risk based monitoring for their clinical trials. Risk based monitoring moves from the traditional methods involving 100% or complete SDV to PSDV (partial source data verification). It introduces strategic on-site monitoring that is based on risks and assessments about important aspects of clinical trials.

For PSDV, you plan the SDV process by using statistical and historical information about the clinical sites and the involved personnel and about events that occur at various points in the clinical trial. This planning involves decisions at various levels of the clinical trial. Some information included in partial source verification follows:

• Percentage of CRFs to verify

• Specific CRFs to verify

• Specific pages of the CRFs to verify

• Adverse events at specific points in the clinical trial