16 October 2008 VIEW on ESolutions ECLINICAL Multifunction eClinical systems are becoming the norm for capturing and managing data in clinical trials. Unfortunately, the training of site staff to use these systems is still taking place in one on one sessions or at investigator meetings. The use of these traditional training methods is often logistically cumbersome and expensive, and can be infeasible for large scale global trials. Additionally, the benefits of using eClinical systems can be diminished if investigator/site staff are not adequately trained, which can directly contribute to delays in clinical studies. State of the art eLearning offers a significantly improved solution that can help train site staff on EDC effectively and efficiently. Integrating eClinical with eLearning When rolling out traditional training, sponsors face many challenges, including scheduling across numerous individuals and diverse sites, handling cancellations and manually tracking each user’s attendance and completed coursework. These complications can be minimized by using an end to end eClinical system that includes learning management system (LMS) functionality and offers eLearning courses that are available on demand, so that training is truly accessible anywhere, anytime. An ideal solution removes time delays found in most training approaches, including many eLearning systems, by immediately granting users with study access after completion of the training. Such systems should automatically generate online training certificates to site staff upon successful course completion. Following certification, users should also have the ability to continually access course content as a reference when needing a refresher. An integrated eLearning system should make detailed reports avail able in order to monitor the training progress of site staff and should satisfy regulatory compliance requirements for managing and maintaining training records. Working Locally Localization is a key element of any eLearning program, particularly in areas of the world where clinical site staff are often new to EDC In these settings, eLearning courses ideally are available in multiple languages and address all local nuances. For enhanced ease of use, cutting edge eLearning solutions adapt to each user’s language preferences and automatically deliver the matching version of the course ware. True ROI Challenges in training are compounded when implementing eClinical systems on large scale global clinical trials. In addition to the initial effort to train vast numbers of global sites, there is also the need to continuously train due to site staff turnover during the trial.The logistics of planning, scheduling and delivering training can carry a very high cost both to a trial’s budget, but more importantly to a sponsor’s staff. These factors can pose a serious threat to the timely startup of sites and their ability to enter data, which can lead to costly delays downstream. Such delays, accumulated over many trials, can slow down an overall clinical program. Clearly there is enormous potential for savings — both in terms of trial cost and trial timelines — by combining data management capabilities and training delivery into one unified eClinical system. When evaluating EDC solutions, ensure that integrated, global eLearning is included. MEDIDATA SOLUTIONS’ Rave platform offers integrated eLearning that enables the world’s most advanced life science organizations to maximize the value of their clinical research investments. For more information, visit mdsol.com. eClinical Meets eLearning Integrated eLearning Enables Efficient and Streamlined Global Trials eLearning is the new paradigm for training site staff and when integrated with EDC, it accelerates site access and ensures training compliance. Medidata Solutions Course Best Practices For training to be successful, the eLearning course ideally offers: . Self paced and continuously available content. . Role specific courses for site and sponsor staff so that their time is focused on learning exactly what they need to accomplish. . Bookmarking functionality, which allows the users to exit and return to their place in the training session. . Transcripts of all narration in the course available to view and download. . Visual tools to keep the learners engaged, including demo functionality, built in quizzes, inline assessments and practice simulations. . Graded final examinations that assess the user’s ability to participate in the clinical trial. . Surveys, which can be administered to gather feedback after the user has completed the eLearning course. Daniel Mudgett Vice President, Knowledge Management Ashwin Mundra Manager, Knowledge Management Technology for a healthy world. www.mdsol.com 1.212.918.1847 Are your clinical data systems playing together nicely? Medidata Rave leads the industry in EDC, providing effortless interoperability with all your clinical data systems. But don’t take our word for it. CDISC has certified us* on all eight ODM use cases. Standards make data easy to get in and easy to get out. They take the struggle out of integrations. Medidata Rave Sharing doesn’t have to be so hard after all…

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