Wayne Martin - Comment

Document ID: FDA-2011-D-0597-0014
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: October 31 2011, at 12:00 AM Eastern Daylight Time
Date Posted: November 14 2011, at 12:00 AM Eastern Standard Time
Comment Start Date: August 29 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: November 28 2011, at 11:59 PM Eastern Standard Time
Tracking Number: 80f62936
View Document:

This is comment on Notice

Draft Guidance for Industry; Availability: Oversight of Clinical Investigations; A Risk-Based Approach to Monitoring

View Comment

The content of this draft guidance is really nothing new; risk-based approaches to data monitoring have been implemented by many sponsors over the past 10 years. Unfortunately over the past 10 years the research landscape has also widely changed at the investigative site end with regard to the training/experience of site staff performing data capture. (In today's tight economy more and more sites are hiring people without medical training and/or research experience.) While remote/central data reviews are an invaluable adjunct to monitoring when an EDC system is utilized, it is unrealistic to expect that edit checks and reviews for data outliers, etc. will ultimately result in the same level of data accuracy resulting from on-site monitoring of data against the actual source documentation.