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When a protocol deviation or non-compliance occurs in a clinical trial, documenting the event is only the first step. Regulatory authorities and Good Clinical Practice (GCP) guidelines require a thorough investigation into the root cause to prevent recurrence and to ensure data integrity and subject protection.
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When deviations from protocol occur in a clinical trial, documenting the event isn’t enough. Regulatory bodies such as the FDA, EMA, and MHRA expect sponsors and investigators to conduct a structured Root Cause Analysis (RCA) that identifies the underlying causes—not just the symptoms—of non-compliance. This ensures effective CAPA (Corrective and Preventive Action) and prevents recurrence.
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The 5 Whys technique is a simple but powerful Root Cause Analysis (RCA) tool that helps uncover the true origin of a problem—not just its symptoms. In clinical research, where protocol deviations can disrupt subject safety and data integrity, identifying the root cause is essential for implementing effective Corrective and Preventive Actions (CAPA).
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When a protocol deviation occurs in a clinical trial, identifying the true root cause—not just the immediate symptom—is vital. Regulatory agencies including the FDA, EMA, and MHRA increasingly expect structured Root Cause Analysis (RCA) approaches. One such tool that facilitates this process is the Fishbone Diagram, also known as the Ishikawa Diagram or cause-and-effect diagram.
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Root Cause Analysis (RCA) is a regulatory expectation under GCP for managing protocol deviations and preventing recurrence. While sponsors and CROs often have centralized quality systems, many protocol deviations originate at clinical sites—making RCA training at the site level a critical quality initiative.
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Protocol deviations are inevitable in clinical trials due to the complexity of procedures, human involvement, and real-world operational challenges. However, repeated deviations of the same type signal systemic weaknesses—often due to insufficient root cause analysis (RCA) and inadequate corrective or preventive action.
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Root Cause Analysis (RCA) is a key requirement under ICH-GCP guidelines for investigating protocol deviations, adverse events, and non-compliance in clinical trials. However, it’s not enough to simply conduct an RCA—the quality of documentation is what makes the difference during audits and regulatory inspections. Incomplete or unstructured RCA documentation has been a frequent finding in inspections by agencies such as the FDA, EMA, and MHRA, leading to citations and questions about data integrity.
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In clinical trials, regulatory inspections by agencies like the U.S. FDA, EMA, MHRA, or local health authorities are conducted to assess GCP compliance, subject safety, and data integrity. One of the most scrutinized aspects during these inspections is the sponsor or investigator’s ability to identify, investigate, and correct protocol deviations or process failures through a structured Root Cause Analysis (RCA) process.
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Root Cause Analysis (RCA) is a systematic approach to identifying the underlying causes of problems, such as protocol deviations, audit findings, or operational inefficiencies. In clinical trials, RCA is not a standalone activity—it should be fully embedded within the sponsor or CRO’s Quality Management System (QMS). Regulatory agencies, including the FDA and EMA, expect that RCAs be documented, reviewed, and acted upon within a controlled quality framework.
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