FDA Ready™

GuideStar prepares research directors and staff for potential FDA audits giving the team confidence in its compliance and readiness.

The FDA shows up at your door announcing an inspection of your research program or IRB.  How would the staff handle an inspection? Are your documents in order and readily available for the inspectors? How would the program fare under the FDA’s microscope?

The FDA is vigilant about ensuring clinical research is conducted in accordance with regulations.  That means any hospital or physician practice conducting clinical trials may be inspected by the FDA.  Because research programs receive little or no warning about an impending inspection, it’s critical to ensure that the program is always FDA Ready.  And GuideStar can make sure it is.

An inspection is not necessarily the result of an error or problem but is rather the FDA’s way of monitoring those involved with research to make sure everyday operations are up to the strict standards applied to human research.  But, it is critical to be FDA inspection-ready to assure your program isn’t disrupted with findings that cause serious alarm. That assurance is what FDA Ready provides.

How FDA Ready Works

The GuideStar FDA Ready team includes professionals with extensive research program management experience and former FDA auditors who examine the research program with a critical eye.  Knowing how the FDA actually performs inspections gives your team experience in not only the information that should be provided, but how to actually manage the process and discussions during the inspection.  In addition to conducting a mock audit, the FDA Ready team provides a comprehensive assessment of how well the program is prepared along with valuable guidance for continued preparation.

To keep the mock inspection as realistic as possible, a mock Form 483 will be provided to the research program.  Then the FDA Ready team will go on site and act as FDA inspectors.

But it’s not just about the inspection—it’s critically important to know how to respond to the post inspection report.  GuideStar will issue a report similar to what the FDA would send post inspection and provide guidance in the development of a mock corrective action plan.

Areas of the research activity or the IRB to be evaluated during the inspection include:

    • Policies, SOPs and workflows
    • IRB meeting proceeding documents and communications
    • Regulatory document management
    • Oversight structure and process
    • Internal audit procedures
    • Staff and PI training policies
    • On-site storage and security of trial materials
    • Electronic data security/ 21 CFR Part 11 compliance

The FDA Ready Action Plan Report

GuideStar will provide a detailed, objective report of the findings including:

  • Steps to address areas of immediate and highest concern
  • Recommendations to improve the efficiency of the program
  • Access to GuideStar’s proprietary templates for FDA readiness
  • An overall action plan for the program that, once implemented, will introduce compliance checkpoints

To ensure all questions and concerns have been adequately addressed after the mock inspection, GuideStar will provide four additional hours of FDA inspection-specific consulting that can be used up to a year after the FDA Ready service.