The Clinical Research Training Program Checklist: What to Look For
Training is an essential and often required, component of conducting clinical research. Effective training teaches researchers how to ethically and compliantly execute study activities, communicate with participants, manage regulatory requirements, interact with research tools and technology, and provide proper oversight of staff. Despite their potential impact on a study’s success, training programs are often outdated, unengaging, and redundant. Therefore, it is critical to select a vendor or program encompassing not only regulatory requirements but also your organization’s goals. When shopping for clinical research training programs, use the criteria below to ensure your training is engaging, efficient, and effective.
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Training Method and Delivery
How do you plan to deploy and implement your training program? Whether you’re planning to host training in-person, via online platforms, or leverage a hybrid approach, below are implementation considerations.
- End-users can complete the training on their own time, at their own pace
- Learning management system (LMS) is user-friendly and intuitive
- Training is repeatable and consistent across the organization
- Training completion is easily monitored and recorded
- Training is accessible or easily referenced at any time throughout a trial or staff tenure
- Training is available in multiple languages
- Training is engaging (ex: clear visuals, quizzes, polls, interactive components)
- Training offers test-out options of some or all of the content
- Training is available to unlimited users
- Training is positively received by trainees and teams, with proven results
What should the training cover? Every training course should prove detailed enough to ensure your staff and investigators can conduct research but condensed enough to encourage comprehension and completion. That means creating educational and practical course content so your team can understand but execute. Below is a list of research topics for teams new to research. First, select the topics applicable to your team. Second, evaluate the program to understand and compare how much time is required to complete the programs you are considering.
- Introduction to clinical research
- Human Subjects Protection and HIPAA privacy protections
- ICH Good Clinical Practice
- Regulatory and financial startup
- Diversity and inclusion in clinical trials
- Clinical operations and launching the study
- Investigational product management
- Participant recruitment and informed consent
- Executing study visits and clinical trial monitoring
- Assessing safety and AEs, deviations & non-compliance
- Regulatory and financial management
- Readiness for FDA inspections
Program Credibility and Experience
The best research training programs leverage experienced training teams with experienced researchers. There are two key factors to consider when evaluating program credibility:
- Industry-specific: Does the training incorporate industry considerations, regulatory and ethical foundations, and address common challenges research staff feel?
- Industry-backed: Is the program content created by those with real-world research experience?
CME/CEU Credit Options
To maximize a training program’s value, the content and credentials should apply beyond a single instance or event. Below are considerations for maximizing your training investment:
- Recognized by TransCelerate SQT member organization
- Training content qualifies for continuing education units (CEUs) at no additional cost
- Training status or record is logged and accepted across studies, sponsors, or staff
More new-to-research sites are engaging in trials to reach patient populations, achieve enrollment, and startup objectives, and adapt to site staffing shortages and turnover. Unlike other offerings available in the market, Advarra’s Clinical Research Conduct Training integrates required research topics with an operational mindset to ensure researchers can quickly turn knowledge into practice while successfully and compliantly conduct a study, all within a third of the time required for traditional programs.