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Product Details
How to Coordinate Clinical Investigators and Institutional Review Boards to Ensure GCP Compliance
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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Interested in purchasing more than one print copy? Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions.
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