In Alignment with All Major Regulatory Bodies

Our central statistical monitoring technology adheres strictly to the GCP guidelines set forth by regulatory bodies such as the FDA, EMA, MHRA, and PMDA, ensuring users can effortlessly meet the highest compliance and efficiency standards. Discover how our expertise seamlessly integrates with the latest regulatory directives.

Food & Drug Administration (FDA) Guidance

The FDA’s Risk-Based Approach to Monitoring of Clinical Investigations guidance extends the original RBM guidance of 2013, offering clarification on specific questions related to RBM in a Q&A format. It underscores key aspects of RBM implementation, including conducting study risk assessments, emphasizing centralized monitoring, and advocating for thorough documentation of monitoring activities. Issued as the inaugural RBM guidance by a major regulatory body, the Oversight of Clinical Investigations document focuses on the operational phase of trial monitoring. It advocates for reduced reliance on traditional onsite monitoring and 100% source data verification (SDV) while promoting centralized monitoring, including statistical analysis of clinical data. Additionally, it recommends pre-study risk assessments to identify and evaluate risks associated with critical trial processes and data, thereby enhancing trial outcomes and patient safety. These insights are highly relevant to CluePoints clients.

Guidance for Industry Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

A Risk-Based Approach to Monitoring of Clinical Investigations: Questions & Answers

The EMA’s Reflection Paper on RBQM in Clinical Trials was issued shortly after the FDA released its RBM guidance. It promotes the adoption of risk-based approaches to quality management in clinical research, which closely aligns with the FDA’s guidance both in its timing of release and its core content. However, unlike the FDA guidance, the EMA reflection paper places less emphasis on operational study monitoring and instead prioritizes early and ongoing assessment and mitigation of study risks. It introduces the innovative concept of Quality Tolerance Limits (QTLs) to ensure that crucial study processes remain within acceptable ranges. The RBQM processes outlined in this paper, including the utilization of QTLs, serve as a precursor to the subsequent ICH E6 (R3) update.

Guideline for Good Clinical Practice E6(R2)

The MHRA released guidelines emphasizing tailored approaches to clinical trials and oversight of investigational medical products, stressing the benefits of risk-adapted strategies, such as cost reduction and improved resource use. The risk-adapted approach to clinical trials categorizes trials by associated risks and mandates specific assessments to inform management and monitoring strategies. The companion oversight and monitoring guidance outlines strategies aligned with trial risks, including central monitoring and statistical techniques. It also recommends a risk-based approach to source data verification to prioritize verification based on trial risk levels.

Good Clinical Practice for Clinical Trials

Oversight & Monitoring of Investigational Medical Product Trials

The PMDA promotes a risk-based approach to clinical development (GCP) and drug manufacturing (GMP) as outlined in the Japanese Pharmacopoeia, which sets the official pharmaceutical standards for the country. This approach emphasizes managing risks from the initial development stage through post-marketing activities to ensure patient safety. Additionally, the Japanese Ministry of Health, Labour & Welfare supports risk-based monitoring, recognizing its potential to improve efficiency over SDV and provide clinical trial safety. They specifically reference the FDA’s and EMA’s 2011 draft guidance regarding risk-based monitoring, indicating a desire to harmonize standards and approaches to risk-based study execution.