PDF Edition - Managing Clinical Investigator Compliance: A Guide to the FDA Requirements

March 2010
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You expect that clinical investigators will keep study subjects safe. You expect they’ll protect the integrity of data, too. After all, both are critical for FDA approval of your drug or device — or for agency approval of a new use for your existing product.

And the FDA gives sponsors like you specific responsibilities to see that investigators don’t cut corners during a clinical trial.

So, how do you make sure researchers affiliated with your company are in compliance? And at the same time, ensure compliance for their associated nonmedical personnel?

It’s all in Managing Clinical Investigator Compliance, the management report from FDAnews that brings you up to speed on the latest requirements for investigators. Order your copy now and you’ll soon be able to:

  • Access a complete overview of the core requirements of the FDA “investigator responsibilities” guidance
  • Discover how the FDA determines if investigators are overburdened — telltale signs the agency uses
    to decide who should not be doing a study
  • See which investigator tasks must be performed by medically qualified staff
  • Pinpoint tasks the FDA says should NOT be delegated by investigators to ANY other staff
  • Judge whether key staff are truly “medically qualified” — per the FDA’s definition!
  • Know what training is required for any and all staff involved in clinical trials
  • Make sense of what the FDA means by “adequate supervision” of a study
  • And so much more

Increased focus on the once-overlooked area of clinical investigator compliance is already here. So why wait and worry if an investigator’s mistake will threaten your product approval with the FDA?

Stay in control ... stay in compliance ... stay one step ahead of your research affiliates: Order your copy of Managing Clinical Investigator Compliance now.

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