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Barnett Releases Reference Guide on Form FDA 1572--Statement of Investigator
Date:10/11/2008

xplores emerging areas of uncertainty related to the growing complexity of today's clinical trials, including:
  • When must a non-US clinical investigator sign a 1572?
  • How can a clinical investigator determine when a member of the site staff should be identified as a "subinvestigator"?
  • What are the legal/regulatory implications of signing a 1572--is it a legal contract?
  • When can a sponsor consider a clinical investigator to meet the "appropriate expert" standard?
  • What do we do now that at least one foreign country has banned the use of the 1572 for its clinical investigators?
  • How should "co-investigators" be handled in the 1572?
  • Must clinical investigators sign 1572s for "satellite sites"?
  • What must a study sponsor do beyond "collecting the paper" in the 1572 process?

The Form FDA 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors is available from Barnett Educational Services for $45 per copy (bulk discounts available) by calling 1-800-856-2556 or click here to order your copy today.

About Barnett International
Barnett International is a recognized leader in clinical education and training for all levels of staff involved in the drug development process. In addition, Barnett is the publisher of the GCP Q&A Guide, the PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook, and other well-known reference manuals that help research facilities ensure compliance by providing updates about the latest federal regulations, while offering executives valuable information garnered from real-world studies, analyses, and widely respected industry opinion leaders. For more information on Barnett's publications and educational programs, visit '/>"/>

Source: PRWeb
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