Engaged. Knowledge. Application
FDA Inspections of Clinical Research Sites: A Preparation Primer
This 20+ page “how to” instructional article includes the following information below:
- Origin of FDA GCP inspections
- When FDA GCP inspections are conducted?
- Management of FDA GCP inspections
- Anatomy of an FDA GCP inspection
- Which areas FDA inspects during the clinical research process
- Good documentation practices
- Which GCP deficiencies does FDA find during clinical research inspections
- Top 5 bioresearch monitoring FDA inspectional observations
- Most frequent FDA GCP inspectional observations
- After the inspection-FDA follow up inspection actions
- Sample FDA GCP Warning Letter
- Determinations that an FDA Investigator must make during a Clinical Investigator Inspection
Article Excerpt
"An FDA investigator ensures a thorough inspection of a clinical investigation site by acquiring documented evidence to these key questions:
- What was the source of the subjects?
- Did the subjects exist?
- Did the subjects have the disease being studied under the study?
- Did the subjects meet inclusion/exclusion criteria?
- Was consent obtained?
- Was IRB approval of required study documents obtained?
- Was the clinical protocol followed?
- Did the subjects receive the assigned study drug in the dose, administration route and frequency specified by the protocol?
- Are case report forms complete and in agreement with source data (compare to NDA data listing)?
- Are records and reports adequate and complete?"
End Excerpt
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