FDA Clinical Trial Compliance Guide – New Study Requirements?

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The process of getting a drug approved is long, strenuous, costly, and difficult. New drugs can take anywhere from 6-11 years to approve.

To avoid setbacks and one of the best things that clinical investigators, site managers, regulatory affairs staff, research and development teams, and lab managers can do is to have the right information on hand. In doing so, those looking to get new drugs approved will have an easier time.

To date, the FDA has issued “more than 100 guidance documents” that identify information such as the Animal Rule and the right validating software to use in studies. While individuals can certainly go through the paper text versions of the documents, the process has now gotten so much easier.

About the FDA Clinical Trial Compliance Guide

Recently, the FDA has released its online version of the documents, complied into one neat product called FDA Clinical Trial Compliance Guide. This guidebook features the “FDA’s most crucial guidances on clinical research.” The management reports included in this guide cover the following topics:

  • The components of an FDA inspection
  • Compliance rules for in-vitro diagnostic devices
  • The reporting process for events adverse to an IRB
  • The process of establishing and operating data monitoring committees
  • Responding to investigator misconduct
  • Requirements for Investigational New Drugs (IND) and Investigational Device Exception (IDE)

In addition, the FDA Clinical Trial Compliance Guide also features information about trial sponsors, medical devices, trial management, investigators, GMP/GCP, HDEs and HUDs, electronics and software, data management, biologics, and international conference on harmonization.

FDA Clinical Trial Compliance Guide Conclusion

Those who are interested in viewing a sample of this compliance guide can do so through the FDANews website. The sample provides an ample amount of insight so that interested individuals know what to expect.

Further, the guidebook comes in a completely searchable format. This way, those who purchase the guide do not need to spend hours looking through it. The PDF version is currently priced at $397 and downloads immediately upon ordering.

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