Product Details
The FDA and the European Medicines Agency (EMA) spell out just what they’re looking for in their inspections, yet the same common observations arise year after year. Sites are failing to follow investigational plans, keep inadequate study records and provide sufficient informed consent — to name just a few deficiencies on the consistent list of shortfalls.
Why, with the guidelines and history available, aren’t clinical trial sites improving? The main source of complications isn’t a lack of training. It isn’t scarce resources dedicated to these topics. It isn’t pressure from sponsors. It’s confusion around what exactly these requirements mean.
Through the Avoiding Inspection Pitfalls: Understanding Common FDA and EMA Observations management report, you will get a detailed look into the most frequent observations found in FDA and EMA inspections. It will provide examples of where other sites went wrong, explaining the complex requirements laid out by these agencies in a straightforward, easy-to-apply manner. You’ll discover how to create processes that will work for you and determine how you can best respond to a regulator’s findings.
Management Report Takeaways:
- Common FDA and EMA Observations
- Failure to follow an investigational plan
- Inadequate study records
- Inadequate supervision of investigational product
- Informed consent issues
- Safety reporting issues
- Insufficient IRB oversight
- Data on Investigator Inspections
- Number of investigator/site inspections
- Information on severity of results
- Manuals and Documentation
- Creating a clinical trial procedures manual
- The importance of financial disclosures
- Examples of corrective and preventative action plans
- Developing an FDA inspection preparation checklist
While the FDA and EMA state what they’re searching for during an inspection, they don’t spell out how to fulfill each of those demands. Avoid the confusion. Find the answers you need to navigate your next review — and sidestep some of the most common blunders — in Avoiding Inspection Pitfalls: Understanding Common FDA and EMA Observations.
Who Will Benefit
- Site and research center staff
- Academic teams
- Research teams
- Medical center staff
- IRB teams
- CRO teams
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ISBN-13:
978-1-60430-171-7
Publication date:
Sept. 2021
Page count:
180
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