Risk-Based and Central Monitoring of Clinical Trials


This week, our friends at The Society For Clinical Research Sites sponsored a Top Tier Topic Webinar withTranscelerate Biopharma on Transcelerate’s Collaborative Approach to Risk-Based Monitoring (RBM). The Webinar focused on the impact of RBM on the clinical research sites. Last year we wrote a paper on this topic with Accumed Research Associates, a clinical research site under the direction of Mitchell Efros, MD and Kerri Weingard, ANP.  The article demonstrates, with supportive data, that when done properly, RBM and central monitoring, tied in with direct data entry (DDE) at the time of the office visit, can double productivity at the clinical research site. The main reason is that there is virtually no additional work once the study subject leaves the clinic and there is no need for source document verification, as “the data are the data.“ Here is the conclusion from the article:


With the adoption of RBM and DDE at the time of the office visit, the paradigm for conducting and monitoring clinical trials is changing dramatically. DDE significantly reduces the workload of the clinical research sites and there is no need for the CRAs to verify data transcription errors. When data are entered directly at the time of the subject’s visit, online and real time business logic and range checks identify any potential data entry errors or inconsistencies. Generic and study-specific reporting on metadata and study data (e.g., batch edit-checks, IMP management) will lead to greater value-added data management activities, while the less valuable elements of traditional monitoring (e.g., SDV), will disappear. The focus of monitoring will switch from checking data transcription to assurance that the site staff are trained on and following the protocol. The business benefits have potential to be transformative.


ON TARGET is the newsletter of Target Health Inc., a NYC-based contract research organization (CRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services, including the paperless clinical trial, to the pharmaceutical and device industries.


For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.


Joyce Hays, Founder and Chief Editor of On Target

Jules Mitchel, Editor


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