Risk-Based Monitoring of Clinical Trials - Webinar CD/Transcript

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Risk-Based Monitoring of Clinical Trials: Satisfying the FDA

The FDA advises sponsors to adopt a risk-based approach to monitoring clinical trials that focuses on your riskiest sites and protocols.

But when the investigators show up, they're going to review more than that. They're going to look everywhere.

And if they find a problem, they'll view it not just as evidence of a weakness in the way you monitored one site. They'll say the problem is with the risk-based criteria you used to set up your monitoring plan.

Is your risk-based monitoring done the way the FDA expects?

You’ll find out how to design and implement a risk-based clinical trial monitoring program, starting with key concepts such as:

  • The technology you must put in place to implement centralized monitoring
  • Why the distribution of data across your study sites might trigger an alarm
  • Key metrics that point to poor performance and noncompliance
  • The minimum number of site visits you should be conducting — regardless of the risk

In just 90 minutes, this session will give you a roadmap for establishing a risk-based monitoring plan that will 1) ensure there are no data "surprises" in your monitoring that could be revealed during an inspection … 2) help you be fully compliant … and 3) satisfy the FDA.

In addition, you'll take away these invaluable specifics:

  • The 5 data points that you must always monitor
  • 9 essential critical risk factors your monitoring plan must consider
  • The 5 key components that should make up your monitoring plan — and what they each should contain
  • Must-have documentation requirements for every monitoring plan
  • Non-monitoring considerations: how to be sure your risk-based monitoring doesn’t undermine other elements of trial compliance

Whether you're hoping to improve your risk-based monitoring or considering it for the first time, order the CD and transcript of the Risk-Based Monitoring of Clinical Trials: Satisfying the FDA webinar.

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Darshan Kulkarni of the Kulkarni Law Firm is a leading expert on strategic regulatory and pharmaceutical counseling. With a background in both the law and hands-on healthcare experience, Mr. Kulkarni is versed in the needs of international device, pharmaceutical and biopharmaceutical companies and their service providers.