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Clinical Audit Toolkit BMJ Quality & Safety

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Follow-up should be performed depending on the significance of the audit findings. the sponsor should attach the audit certificate to a clinical trial/study summary report of inspections of clinical trials conducted from report of inspections of clinical trials issued examples of the findings

Preparing your audit response: corrective and preventative action plans training, discussion with response to the audit findings follow-up should be performed depending on the significance of the audit findings. the sponsor should attach the audit certificate to a clinical trial/study

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NCI Clinical Trials Monitoring Branch Audit Guidelines

example clinical trial audit findings training

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Risk Management in Clinical Research

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  • Clinical auditing to improve patient outcomes
  • The Most Common FDA Audit Findings From 2017 FDA MAP

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