Both ICH GCP and federal regulations recognize the monitor’s key role in ensuring the quality and safety of clinical research. Because of their extensive experience in clinical trial rescue and Corrective Action Preventative Action (CAPA) plans, MRM has identified several common causes where inadequate monitoring has contributed to costly delays and deficiencies in a clinical trial:
The MRM Step Method™ is a systematic approach to monitoring that encourages critical thinking and thorough documentation. The Step Method™ was developed after extensive review of real-world audit findings and noncompliance issues. MRM recognizes that experience alone is not enough to ensure high-quality monitoring — CRAs require tools, training, and mentoring with performance assessments. Comprehensive therapeutic area training is needed for CRAs without a medical or without the knowledge of the disease or condition being studied. The MRM system has a long track record of success, including complex oncology studies using a majority of entry-level CRAs.
MRM’s monitor training program utilizes systematic tools and hands-on experience to address the root causes of inadequate monitoring. MRM CRAs learn how to use and design GCP-based tools that are customized for each protocol and CRF. For example, the informed consent tool guides the CRA through an 8-point consent verification designed to establish GCP compliance and reduce audit findings. These standardized tools streamline the report writing process, provide a work product for review, and can be integrated into operational listings and metrics to aid in the management of the overall monitoring process. At the end of a study, monitoring tools can be used to prepare a site for an FDA BIMO inspection.