Yes, since March of 2011, FDA’s Bioresearch Monitoring Program has been focusing more on a sponsor’s computerized system since the industry best practice has been to use electronic case report forms (eCRF) to capture data generated during clinical trials. The FDA will assess the sponsor’s system for development of the eCRF, training on eCRF and how sponsors handle changes to the eCRF. In addition, the FDA will look at the interface between the eCRF and the database. Another area of focus is the qualification and contracting out of statistical analysis of the data. In general, future FDA sponsor/monitor inspections will review the qualifications of the personnel who are involved in the computer operations group that supports clinical trials, just as they have reviewed the qualifications of the clinical personnel previously.
