FDAnews Announces — New Management Report — Clinical Trial Compliance Guide: FDA Requirements



More than 100 guidances have been issued by the FDA on clinical trials ranging from the Animal Rule to validating software.

If manufacturers had to pull all of the clinical trials guidances together and get the right version it would take hours.

But, thankfully FDAnews has done just that.

Clinical Trial Compliance Guide is the searchable, one-stop source of all the FDA’s clinical trial-related guidances. The management report includes:

  • How to report adverse events to an IRB
  • How to establish and operate data monitoring committees
  • How to react to investigator misconduct
  • Investigational New Drug (IND) and Investigational Device Exemption (IDE) requirements
  • What to expect from an FDA inspection
  • Rules for working with in vitro diagnostic devices

The guidances cover:

  • Adverse Events
  • Biologics
  • Data Management
  • Electronics and Software
  • HDEs and HUDs
  • INDs and IDEs
  • Informed Consent
  • International Conference on Harmonisation
  • Investigators
  • Medical Devices
  • Trial Sponsors
  • Trial Management

Clinical Trial Compliance Guide: FDA Requirements is the searchable digital manual for the clinical trial information manufacturers need.

Who Will Benefit:

  • Clinical investigators
  • Site managers
  • Regulatory affairs staff
  • Research and development department
  • Lab managers

FDAnews Management Report Details:

Clinical Trial Compliance Guide:

FDA Requirements

Price: $397


Easy Ways to Order:

Online: http://www.fdanews.com/products/53708-clinical-trial-compliance-guide

By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

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