Many believe good monitoring should heavily focus on Source Data Verification (SDV), which stripped down to its simplest meaning equates to “X=X” and “Y=Y”. And maybe some of you reading this are thinking “Isn’t that exactly what monitoring is?” While data integrity is absolutely essential, it is only the beginning of what comprehensive monitoring encompasses.
The key to describing the critical role of a device monitor lies with 21 CFR 812.46, which states:
- Sponsor should secure compliance through monitoring of investigations
- If an investigator is not complying with the investigator agreement, protocol, federal regulations, IRB requirements…device shipments should be discontinued and the investigators participation should be terminated
Therefore, to adequately fulfill regulatory requirements, monitors need to have solid knowledge of the agreement, protocol, regulations and IRB requirements in order to recognize non-compliance. SDV only goes so far, leaving a huge gap in expectations and practice.
Monitors out in the field are bogged down with pressures to get through certain amounts of data, assist with query resolution, and other tasks associated with SDV. As a result, the highest number of warning letter citations issued over the years are not related to data at all, but to compliance with the protocol and investigator agreement.
Has anyone else experienced situations where this misalignment between project expectations and regulatory expectations have led to less than favorable results?
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.