Investigator Training

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12 Ways to Improve Training for Clinical Studies training for clinical studies Investigator meetings are, in fact, training sessions. But there is a tremendous gap between current prevailing practices and best practices in preparing study sites to conduct individual clinical trials. Improved training of study-site staff can produce many benefits, including faster study start ups, improved performance by study sites, reduced costs, and better documentation. Here are 12 tips for helping pharmaceutical and biotech companies address training challenges and use proven adult learning practices to better train study-site staff. 1Use hybrid meetings that combine in-person and remote audiences. Hybrid meetings that include remote online training provide opportunities to reach participants who could not attend the meeting in person. For these individuals, hybrid training can eliminate travel costs while reducing two to three days of training to a three- to four-hour commitment. 2Provide speaker skill workshops for study teams. Almost any individual can benefit from formal speaker training. Clarity, eye contact, inflection, and posture are imperative for commanding attention and motivating listeners. 3Use training professionals to help prepare presentation (slide) content. Experts in science and medicine are not necessarily experts in organizing effective training presentations. Training professionals can assist presenters to ensure that presentations focus on key learning objectives, messages are delivered clearly, and presentation materials are well organized. 4Separate training curricula for investigators, coordinators, raters, and others. Investigator meetings address several distinct audiences all with differing study roles. Curricula should include break-out sessions that are carefully structured to maximize the time of each audience. 5Develop Web-based, self-learning modules. Many of the topics covered during investigator meetings, such as SAE and GCP, are repetitive and mundane to experienced researchers. To ensure these topics are covered while also respecting investigators’ time, topics can be delivered as Web-based self-learning modules. 6Conduct learning assessment to test out site staff. Learning assessment is a core component of adult learning but rarely performed with study-site staff. Systematic testing can be performed easily and offers numerous benefits, such as learning reinforcement, tracking training quality, improving performance, and documenting training of individuals. 7Reinforce training beyond the study launch. Training should not be a one-time data dump. Training should be planned and not held in response to problems, as is the case with most mid-study meetings. An ongoing program of training reinforcement can anticipate challenges, such as patient recruitment, and address them before they escalate into problems. 8Drive site staff performance with motivational measures. Performance by study-site staff is driven by more than training. Organizers should continually motivate participants by regularly reinforcing study goals and key message points. This can be done using a series of positive communications and simple reminder items. 9Use e-media to lower costs without sacrificing quality. Live investigator meetings can be reproduced online as self-learning modules for a fraction of the cost of the original meeting. This is an ideal method for extending the reach of training to participants who could not attend the meeting. Provide resources for English-as-second-language (ESL) learners. It is fallacious to assume that all meeting participants, especially ESL learners, will adequately understand key training material. Traditional options for ESL learners, such as simultaneous translation, are expensive and often impractical. ESL learners can benefit greatly from user-friendly self-learning modules, either with translated material or even in English, allowing them to slow down the pace and repeat any material. Provide a Web-based learning management system (LMS). An online LMS is a sensible way to centralize training resources for convenient and cost-effective use. An LMS allows authorized users to access online training courses, register for training events, and test out where required. Importantly, an LMS provides learners with a scoreboard showing various training and study components and indicating the completion status of each component. Track and document the training completed by each individual by study sites. A comprehensive training program enables study sponsors to track that each study-site member has completed various activities and, where needed, tested out. In addition to training modules, study sponsors can track individuals who attended mid-study updates, reviewed protocol amendments, responded to polling questions, registered for upcoming programs, and other activities. Source: William Cooney, CEO and President, MedPoint Communications Inc., Evanston, Ill. MedPoint Communications provides innovative communications services to global pharmaceutical and biotechnology clients. For more information, visit medpt.com. PharmaVOICE welcomes comments about this article. E-mail us at feedback@pharmavoice.com.

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