I. U. S. Army Medical Research Institute of Infectious Diseases
Directorate of Information Management
Fort Detrick, MD
- Focus: Clinical data management compliant with FDA regulations and 21 CFR Part 11.
- The Challenge: Clinical trials studies for special vaccine development require the collection, storage, retrieval and archiving of protocol specific data that is efficient, cost effective and compliant; however, multiple vaccine development studies possess a number of distinctive characteristics that demanded unique solutions. In most vaccine clinical trials, participation in one study excludes participation in another study. Special vaccine trials have subjects enrolled in multiple studies simultaneously for protection against occupational exposure. This can confound conclusions because of different dependent variables among protocols. For 900 volunteers enrolled in this study, with an average of 3.5 protocols each, the subject burden for these studies was 3150. Using traditional clinical data management systems (CDMS) utilized by the pharmaceutical industry, data common to separate trials were repeatedly entered into different Case Report Forms (CRFs), which increased input errors and created a non-interactive system.
- Our Approach: We aimed to reduce complexity, and establish and refine automated reporting to obtain new data points which could be analyzed. This included a novel database design using a commercial-off-the-shelf CDMS that fulfilled both investigator requirements and FDA regulations.
- Our Solution: We identified the bottlenecks and their root causes, and solved all of them in unique fashion. We designed and implemented a new, single database file architecture that collected patient information into a single Master Source Record which automatically copied study-specific information using electronic silos customized to individual clinical protocol. Thus, data entry and editing occurred in the Master Record only and not in individual protocols.
- Business Gain: Our new database-assisted approach lowered regulatory risk by producing protocol specific records in a more efficient and accurate manner. The design delivered a cost-effective, time-efficient CDMS, compliant with FDA regulations, while meeting unique clinical trial requirements. This provided significant savings in time, effort, and funding requirements, while allowing real-time assessment of the health status of immunized personnel. The concept was expanded to pre-clinical studies for compliance with the newly implemented FDA 2-animal rule.
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