FACT: Training and training efficacy in clinical research has real impacts on speed, efficiency, and overall productivity and performance. 

Like any other type of business, clinical research teams are seeing the benefits of learning management systems to improve their training programs. What makes clinical research different, is that the goal of personnel training is to achieve maximum performance while executing with precise adherence to compliance standards dictated in global regulations, study protocols, and SOPs.

When study protocols and SOPs are established for a study, they need to be distributed for training. Teams also need to be made aware of all of the regulatory considerations that impact their daily work. Role-specific training around this content needs to be created and distributed. Managers need to be able to track progress and completion. They also need proof that training occurred and that each team member successfully completed the training so that they can supply reports to any inquiring regulatory agency during an inspection. Any misses during an inspection result in potential penalties and fines that are easily avoided through effective training on operating procedures. A compliance-focused learning management system (LMS) addresses all of these specific considerations.

Here are three core functions of a compliance LMS that help to bake best practices into your operations:

1. Automation

   Remove human error from your training programs by automating critical processes. Study-specific training is mandatory in clinical research because studies must be conducted within established compliance standards. Protocols, SOPs, and content on relevant regulations can all be distributed automatically through an LMS. Once distributed, progress and completion rates can be tracked and certifications provided to validate completed training. All of this is automated.

   In addition, it makes sense to integrate the learning management system with the system where most of your study staff information is stored—allowing for even greater centralized visibility into your study staff data. The training certificates can be automatically sent to the eTMF to the correct location of the index based on the DIA TMF Reference Model. With all of this happening automatically, teams avoid time-consuming content delivery, mistakes in manual tracking, lack of transparency into progress and completion, paper certification, and inefficient transfer to the TMF. Automation isn’t just an advantage of compliance LMS, it should be considered a best practice that the LMS provides.

2. Centralization

   Training programs consolidate many different components associated with learning, and so it makes sense you would want to centralize all of that information. A single training repository for all your compliance training courses, SOP documents, e-learning SCORM modules, and even assessments, makes access and updates easy.

   Centralization also enables a single place to upload multimedia content like PowerPoint presentations, training videos, and high-end HTML5 content. Centralization gives your teams the ability to go through modules in their own free time and access it as needed. An often overlooked component of training is reinforcement (in other words, revisiting training materials after formal training has taken place). Training is most effective when people revisit the content. Many may consider centralization a feature, but it is also a necessary best practice.

3. Analysis

   “If you can't measure it, you can't improve it.”
   – Peter Drucker

   Constant visibility into a training program is just not possible without a learning management system. In fact, a number of organizations in highly regulated industries find it critically important to demonstrate learning compliance. However, only a small minority of these companies are able to claim that they are highly prepared for a compliance audit. Without a system that is constantly updating in real time with learner activity, programs are always operating in hindsight and with potentially flawed data.

   It isn’t just managers that need to manage though. Learners need to manage their own learner journey. This is much more readily accomplished with simple dashboard analyses of their progress, success in each module, and their proximity to certification. Managers benefit from rolled-up views of this information for every user, as well as more global views of the general trending progress or the team(s). Real-time analysis means better understood learning programs.

The importance of learning management for compliance training goes above and beyond speed and efficiency. The right-fit system, by virtue of its design, will help you embed best practices into your operations simply through the implementation and administration of the technology. In evaluating the evolution of your training programs, consider that the bells and whistles of LMS have broader operational implications that complement teams who need to be optimal in their ability to execute under the scrutiny of sponsors and regulatory agencies. 

For more information on compliance LMS, contact us at info@trialinteractive.com or visit http://www.trialinteractive.com/solutions/learning-management-systems-lms to request a demo.