Corrective Action Road Map Enhances Client Readiness For Regulatory Expectations

A large healthcare company specializing in pharmaceuticals and medical devices identified a high priority need for independent monitors to conduct due diligence visits at investigator sites. The independent monitors were to assess the overall study conduct of two protocols across 22 sites in order to prepare for a potential FDA inspection. The client wanted the assessment to be completed in less than six weeks.

The assessments prioritized data verification for all subjects, including:

• Adverse Event/Serious Adverse Event Accuracy: Review source documentation – including patient diaries -against the data listings to ensure all safety events (SAEs/AEs) have been collected
• Protocol compliance: Ensure all protocol deviations have been collected
• Informed consent documentation: Verify that subjects were appropriately consented
• Monitoring process: Ascertain that monitoring was conducted and documented according to the monitoring plan
• Investigational product: Reconcile product shipments, usage and returns at each site
• Trial master file: Reconcile essential documents to ensure consistency of protocols from site to site.