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One of the most powerful features of a good eLearning solution is the ability for users to repeat a training course and take a test repeatedly to gain mastery of the material.
Successful clinical trials are dependent upon a constellation of factors, including the accurate and standardized collection of data across all test sites. Electronic data capture (EDC), which is at the heart of electronic clinical data management (eCDM) solutions, is an important step toward ensuring successful data collection.1 However, the success of any EDC deployment is dependent upon how well the clinical research coordinators (CRCs) and clinical research associates (CRAs) are trained in use of the EDC solution.
Photography: Digital Vision, Eyewire Illustration: Paul A. Belci
The need for effective EDC training has long been acknowledged. The need was precisely stated in "Supporting EDC in a Clinical Trial Environment," an August 2002 article in Applied Clinical Trials that notes, "Successful deployment and implementation of hardware and software at remote study sites requires both a thorough understanding of the requirements and appropriate planning. Training to ensure an acceptable level of self-sufficiency is essential to the success of an EDC trial."2
Yet the question of how to best approach training remains. Although much work is being done to promote use of EDC solutions, too often the training that accompanies the solutions is based upon older delivery modes with inherent problems that work against efficient deployment of EDC solutions. Typical training solutions, and their challenges, include:
This article makes the case for incorporating eLearning strategies as an integral part of deploying EDC solutions. By eLearning, we refer generically to computer-based training that is accessed by users across the Internet for use at their own time and at their own pace, and that includes a testing mechanism to quantify and document mastery of the material. While we do not suggest that an eLearning delivery platform needs to completely replace all classroom training, we do see eLearning as an effective and efficient delivery mechanism that can be used on its own or as an adjunct to classroom and other training models.
For those who create EDC solutions for the pharmaceutical industry, it does not take long to recognize the benefits of eLearning. Traditional classroom training can fall short of the needs of large multisite and international studies. It is expensive to fly trainers and CRAs around the world, and it is intrusive on the CRCs and CRAs because they are pulled away from their work.
Figure 1. An eLearning delivery platform should have an authoring tool that makes it easy to create content that can be published to multiple outputs. This supports multiple learning modalities.
Traditional attitudes toward training are bluntly stated in "Learn Before You Leap," an October 2002 article in Applied Clinical Trials that finds, "Training programs are considered to be an onerous burden on an employee's schedule. And not surprisingly, training is always last on the budget list and first to be cut."3 Yet the same article also states, "When implementing change in the clinical research process, especially when introducing new concepts or technology applications, this attitude is fatal."
Beyond travel expenses and lost productivity, classroom training simply does not scale well. For large multisite and international research programs, the timing and logistics of bringing CRAs into classrooms is daunting, and in many cases impractical. Train-the-trainer scenarios only partly resolve the issue, while introducing the risk factor of how well the new trainer will convey the material to trainees. In fact, knowledge transfer is a large variable in any classroom situation.
Webcasts do away with travel and greatly reduce the time a CRA is removed from the field (an hour or so, instead of days lost to combined travel and classroom time), yet we have found that attempting to include more than 20 participants in a Webcast leads to what might be called the "rock concert effect." With a crowded Webcast, people can say they were there, but the limited chances for interaction and the distraction of so many voices adversely impact what participants can carry away from the event. One recent project involved training more than 1000 CRAs. At 20 participants per Webcast, that training option would have been impractical.
Meeting CRO needs also motivated us to find a better delivery mechanism. When a CRO begins working on a new study, it needs to be able to get its CRAs up to speed as quickly and efficiently as possible, while at the same time minimizing training expenditures.
Some eLearning solutions use a thick-client architecture that requires users to install custom software on their computer, which can be onerous for the user. Thick-client solutions can also be inefficient for the training organization, as the client software must be able to work across a spectrum of operating systems, and have a mechanism for distributing content updates.
A Web-based solution greatly simplifies life for the user. All they need is a computer with a Web browser. The content is hosted on a server that can be updated immediately whenever content changes.
EDC vendors and others interested in Web-based eLearning solutions should try the authoring tools that are used in creating lessons. The authoring tool should be simple to use and intuitive so that curriculum developers can concentrate on the key knowledge transfers they need to craft and not worry about the mechanics of creating the lessons.
The ideal authoring environment is so inviting that lessons will be updated whenever information needs to be changed, rather than stacking up revisions until someone gets around to creating an updated release. Lessons should be living documents that evolve to meet the needs of the CRO and the CRAs. Easy-to-use authoring tools can help the EDC vendor fine-tune lessons. If testing shows users regularly misinterpret concepts or get confused on procedures, the EDC vendor can rewrite modules until test results show easier comprehension.
The eLearning solution should support multiple outputs, ranging from test scripts used for prototyping to instructor notes, assessment exercises, and job aides. Because CROs operate around the globe, including areas where Internet access can not be assumed, the eLearning solution should also support CD and print distribution.
We believe it is imperative that an eLearning solution support testing. Testing is needed to help CROs document user competency in working with EDC tools, as required by the Food and Drug Administration's Title 21 Code of Federal Regulations Part 11. A typical compliance audit question goes, "Yes, you've got a fine training program, but how do you verify competency?" The electronic tests that users take can be stored and used to show exacting competency.
We feel that the CRO should determine what constitutes a minimum passing score, generally between 80% and 90%. One of the most powerful features of a good eLearning solution is the ability for users to repeat a course and take a test repeatedly to gain mastery of the material.
A related benefit is that CRAs and other users can return to an eLearning module whenever they want to brush up on material. Even if a CRA has already proven proficiency through testing, he or she can log on to the eLearning system and revisit training modules whenever desired. This kind of continuing education is admirable, and helps ensure data quality. From monitoring user activity, we can see that users are indeed returning weeks and months later to revisit specific modules to bolster proficiency. Again, with a Web-based eLearning solution, the user can access the material 24 hours a day, enabling them to work on training whenever it best fits their own schedule.
An eLearning solution provides a powerful tool for dealing with CRA turnover. Especially with multiyear projects, as well as with studies where new sites are added, there can be a need for providing training to new hires. By using the testing capabilities of an eLearning solution, documented competence can be maintained throughout a project, even as new hires are brought on.
eLearning solutions should make it easy to update and customize content. With eLearning there no longer is a need to send out replacement pages or addenda for three-ring binders. Training administrators simply update the content on a server so that everyone who takes the course is using the most recent information. Similarly, if new content is added, an e-mail with the URL to the new or updated module can be sent out to CRAs who have taken the course so they can stay current.
Working with CROs, eLearning authoring tools can be used to customize content to specific studies. Patient intake for each study can be documented, screen by screen, to replicate real-world scenarios. One study we are supporting involves use of a wet lab for animal studies. In this case, we have incorporated detailed videos showing exactly how procedures are performed. Whatever examples are needed to instill competency can be integrated into a good eLearning solution.
The ability to create custom solutions helps build stronger relations with the CRO. Rather than just providing a guide to how to use an EDC product, an easily customizable eLearning solution can help a CRO provide CRAs with a rich guide to the entire project. This approach is based upon the realization that the CRO needs to implement a solution, not just an EDC tool. Working with the CRO to provide customized training fosters a partnership that can benefit the full research effort.
Performance monitoring and proactive use of eLearning can help ensure data integrity over the life of a study. Monitoring might show that one study site, or a cluster of sites, is not demonstrating the proficiency found in other sites. A CRO may want to commission custom eLearning on a per-site basis, addressing areas where testing shows overall lower competency. Such proactive monitoring and response can help ensure that bad data does not creep into a study because of site-specific shortcomings.
A related benefit for the EDC vendor is a reduction in help desk calls. As user proficiency rises, we have seen a drop in number as well as a change in the nature of help desk calls. Callers who have taken eLearning courses tend to ask more sophisticated questions. Instead of calling the help desk to get up and running, they are asking about advanced functionality.
Moving to an eLearning solution in many ways mirrors the learning experience itself. The more that is discovered about the technology, the more possibilities and value are discovered. eLearning needs to be more than just describing how an electronic case report form (eCRF) is used. Following are some basic lessons learned that may benefit others just beginning the process.
Go beyond porting the manual. An eLearning project often begins with the intention of essentially porting material from the application manual or help files into a Web-based guide. At the beginning of a project, there may be value in posting the following note: "e-Learning is not a manual." The real value of eLearning begins when one recognizes the value that can be derived by going beyond existing text and creating a training experience based upon the real-life ways in which the EDC application will be used. As noted earlier, additional value is provided by working with the CRO to create a solution that goes beyond simply using the EDC application.
Use a curriculum developer. Recognize that there is an art and science to good curriculum design. Involving a training specialist with good instructional design experience helps ensure that there is a logical progression to instruction, so that users gain a solid foundation upon which to build their understanding. An experienced curriculum developer can also ensure that testing goes beyond answers based on repetition and actually measures a user's conceptual comprehension.
Create a living document. The greatest benefits from eLearning are derived when an organization embraces the technology to create living documents that evolve with the product, are customized from one study to the next, incorporate best practices from the field, and grow to meet the ever changing needs of the CROs and CRAs.
James Young Kim* is product marketing manager and Kyle Flickinger is vice president of professional services with DataLabs, Inc., 101 Academy, Suite 250, Irvine, CA 92617, (949) 851-2030, e-mail: firstname.lastname@example.org.
*To whom all correspondence should be sent.
1. J. Mitchel, "Meeting the Challenges of Internet-based Clinical Trials," Applied Clinical Trials, June 2004.
2. T. Pellegrino, "Supporting EDC in a Clinical Trial Environment," Applied Clinical Trials, August 2002.
3. R. Waife, "Learn Before You Leap," Applied Clinical Trials, October 2002.