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:
Conflicts of interest
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