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How to Coordinate Clinical Investigators and Institutional Review Boards to Ensure GCP Compliance

$297.00
June 2006
1-60004-036-5
115
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How to Coordinate Clinical Investigators and Institutional Review Boards to Ensure GCP Compliance is packed full of actionable, expert guidance to help you:

  • Build a quality assurance program using a proven framework
  • Identify and remedy common clinical study weaknesses
  • Avoid regulatory action
  • Streamline clinical processes

You’ll have fingertip access to situational strategies and subject-specific updates, such as:

  • The FDA’s perspective on quality assurance
  • The importance of SOPs and protocol compliance
  • When regulations don’t apply: how to handle process gaps
  • Tips for a successful inspection
  • Preparing for and responding to audits: tips and strategies
  • How to develop a written quality assurance program
  • Best practices for coordinating, communicating and documenting all study-related activities

How to Coordinate Clinical Investigators and Institutional Review Boards to Ensure GCP Compliance also delivers five case studies that examine the top site and Institutional Review Board compliance issues, including:

  • Patient confidentiality
  • SAE reporting
  • Conflicts of interest
  • Informed consent
  • Protocol assessment
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