Shweta Nanda
Independent Researcher
Punjab, India
Abstract
Good Clinical Practice (GCP) guidelines represent the ethical and scientific standards that govern the design, conduct, monitoring, auditing, recording, analyses, and reporting of clinical trials involving human subjects. Within regional pharmacy institutions, strict adherence to GCP is essential to safeguard participant safety, uphold data integrity, and ensure that research findings are credible, reproducible, and acceptable to regulatory agencies. This manuscript undertakes a comprehensive evaluation of benchmarking tools specifically tailored to assess GCP adherence in resource‑constrained pharmacy research settings. Employing a mixed‑methods approach—comprising a systematic review of existing instruments, an expert Delphi survey, and pilot implementations across five geographically and economically diverse institutions—we identify and critically appraise four principal tool categories: standardized audit checklists, self‑assessment questionnaires, key performance indicator (KPI) dashboards, and third‑party compliance indices. Our findings elucidate each tool’s strengths and limitations in terms of validity, reliability, user‑friendliness, cost, and infrastructural requirements. Notably, audit checklists deliver granular insights but demand significant time and skilled personnel; self‑assessments foster institutional ownership yet may underreport nonconformities; KPI dashboards enable continuous monitoring but hinge on electronic data systems; and external indices facilitate benchmarking but provide limited diagnostic depth. Drawing on these insights, we propose an integrated, phased benchmarking framework that leverages routine self‑assessments, annual detailed audits, and quarterly KPI reviews, calibrated to local capacities. Implementation guidelines encompass training modules, SOP templates, and low‑cost digital solutions. This composite approach empowers regional institutions to progressively strengthen GCP compliance, ultimately enhancing research quality, participant protection, and regulatory confidence.
Keywords
GCP adherence; benchmarking tools; pharmacy institutions; clinical trial quality; compliance assessment
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