Risk-Based Monitoring Strategy? Eight Essentials for Clinical Trial Training Platforms

Posted by Heather Pitt on Mar 22, 2017 11:07:17 AM

If you are using or considering a risk-based monitoring strategy for your study, ensuring the effective oversight and training of study teams, monitors, principal investigators and coordinators, as well as other extended site staff, can be a huge challenge.

In a risk-based monitoring approach, on-site time for CRAs is typically reduced in favour of focusing more on critical study parameters and a combination of monitoring activities.

The FDA’s Guidance for Industry document titled ‘Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring’ states:

“Without meaningful training prior to the conduct of a study and of appropriate instruction during the study (e.g., when changes are made to the protocol), CIs and their staff may have difficulty carrying out a trial correctly. Sponsors who plan less frequent or limited on-site monitoring should consider the following:

  • Monitoring activities should include sufficient time for discussion of CI's and site staff’s responsibilities, feedback, and additional training, if needed, during the conduct of the study.

  • It may be necessary to implement alternative training (e.g., teleconferences, webcasts, online training modules) and communication methods (see section III .B.1) for providing and documenting ongoing, timely training and feedback, as well as to provide notification of significant changes to study conduct or other important information.”

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  1. Compliance with the FDA Guidelines on Electronic Records and Electronic Signatures in the United States (Title 21 CFR Part 11 of the Code of Federal Regulations) - Some of the regulations on the technical implementations of the clinical trial training platform include having a permanent audit trail of user actions within the system, having a digital version of user signatures for users authorized to perform critical operations, etc., and other general regulations on security of the systems and back-ups.

  2. Ability to Adapt and Scale - Supporting the training requirements of the study team and site staff is an ongoing process. Therefore, the system needs to have the ability to adapt and scale effortlessly to keep up with the changing demands for training.
  3. Mobile Compatible - Users should be able to access courses on the go using any device on any platform, with particular focus on mobile devices. The days of not being able to access material on multiple devices are long gone!mobile_learning.png

  4. Multiple Functions in One Place - Instead of asking your sites to use multiple systems for successful study implementation, look for platforms that consolidate training with other complimentary functions in one place (e.g., communication tools, document repositories, and other implementation supports).

  5. Visually Engaging - The most effective method of training is one that engages learners; the greater the engagement, the greater the effects of training. Your online training system should provide access to courses that are visually engaging, to the point, direct, and which provide the target audience with the right amount and right type of information.

  6. Easy-to-Use - Everything begins with your platform. If the platform is not reliable or is difficult to use, it will be difficult to host quality training content and make information retention problematic for learners. Training platforms need to have intuitive tools and resources that come together in an easy to use and easy to navigate interface. Make sure that you request a demo and trial the system in advance so you can get a true picture of how your training can be used and understand how your stakeholders would use it in the context of your trial.

  7. Reporting Capabilities - This is one key area where your training platform needs to work for you. Due to extensive auditing requirements to fulfil compliance, the system must have extensive reporting capabilities (e.g., training status, completion, certification, and full audit trail). To get solid compliance and engagement reporting, your training platform must go beyond telling you who took the test and what their score was. You need to be able to easily identify and review outstanding risk assessments to know where to take the necessary action. Creating reports should be simple but meaningful to reduce manual admin workloads and keep study managers and monitors informed and involved.

  8. Reminders and Outcome Reports - Look for tools that allow you to create automated reminders that alert learners, help you to ensure course completion, and report successful training outcomes, or non-compliances to the study management and monitoring teams.

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