![]() The auditors’ decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. The studies were graded as “critical,” “major,” “minor,” and “not a finding” (11.9, 39.0, 42.9, and 6.3%, respectively), based on findings and number of deficiencies. Investigator reply rates gradually increased, except for the first year (73% → 26% → 53% → 49% → 55%). We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. ![]() We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 20. The measure includes 20 questions, and results are summarized in five categories of audit findings. The screening audit was developed using a routine audit checklist based on the Severance Hospital’s Human Research Protection Program policies and procedures. Therefore, we developed a simple auditing process (a screening audit) and evaluated its feasibility and effectiveness. ![]() ![]() However, they are laborious, time consuming, and require expertise. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice (GCP) and protocol compliance in clinical research. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. With the growing amount of clinical research, regulations and research ethics are becoming more stringent. ![]()
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