A corrective action plan helps move a problem to an opportunity. Various names are used for these plans: CAP (corrective action plan), CAPA (corrective action and preventive action) plan and SCAPA (site corrective action and preventive action) plan. Develop a corrective action plan for a deficient clinical research site. This site also functions as the sponsor. Review the warning letter and carefully consider how to correct the deficiencies in the short term (corrective action) and how to improve the system so the deficiency will not occur again. Draft a professional response to the FDA articulating action items into letter format as all major regulatory bodies communicate via formal letters.
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