Former Inspector Dissects FDA Trial Guidance

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Patrick Stone, President, TradeStone QA

Alternative monitoring is here. We’ll provide the facts first, and then a little advice.

Sponsor’s of health care products conducting clinical trials for biologics, devices, or drugs, have just been provided with novel approaches to monitoring thanks to the FDA. The agency defines monitoring as “the methods used by sponsors of investigational studies, or CROs delegated responsibilities for the conduct of such studies, to oversee the conduct of and reporting of data from clinical investigations, including appropriate investigator supervision of study site staff and third party contractors.  The primary focus should be on the processes that are critical to protecting human subjects, maintaining the integrity of study data, and compliance with applicable regulations.  The findings should be used to correct investigator and site practices that could result in inadequate human subject protection and/or poor data quality. “ This is a direct quote from the important draft guidance issued in August of 2011 “Oversight of Clinical Investigations A Risk-Based Approach to Monitoring”.

The prerequisite  to implementing and alternative monitoring plan in your project trial master file is the use of all electronic study documentation.  Study documentation includes e-patient source records, e-case report forms, and scanned regulatory records.

Those are some of the key facts. Now here’s some helpful advice.

The cost for using e-records is high up-front, however savings may come with the use of alternative monitoring. Human clinical trials can be monitored remotely from a desk.  The alternative monitoring plan must be  approved by your respective review division up front.

The risk-based approach to monitoring should focus on the most critical data points to ensure subject protection and overall study quality.  Sponsors may be able to monitor the conduct of clinical investigations more effectively than routine visits to all clinical sites and 100% data verification.

This FDA draft guidance was issued to clarify risk-based monitoring with the use of centralized monitoring and technological advances. There may always be a need for on-site monitoring at the beginning, middle and end of a clinical trial which may be more cost effective than going to your site every month. The FDA expects you to tailor your monitoring plan to fit your projects needs and meet the code of federal regulation.

Centralized monitoring and monitoring plan expectations have also been clearly defined in this draft guidance with the option to delegate Sponsor requirements to a contract research organization (CRO).

FDA has also provided clinical investigator training strategies to ensure human subject protection and data integrity. Sponsors & CRO’s are requested to mentor and train study site during the monitor visit. Providing written feedback and reports are a crucial element for compliance with patient safety in mind.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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