Training is often considered a prerequisite and one of the essential components of clinical research. With proper training, researchers understand all the ethical implications of the study and stay compliant with all the regulations throughout the study. To that end, the training aims to teach the researchers about all the steps of the research, from communicating with the participants to returning the results of the research.
Properly designed training programs can have a significant impact on how well the research meets its endpoints. This is why you should always ensure that your training program is effective, efficient, and engaging so that you can meet your goals while staying compliant.
But how can you do it? Here’s a complete checklist to help you develop a top-notch clinical research training program.
The first step is to decide how you’re going to conduct the training. You can choose between in-person, online, and hybrid options, but here are some considerations that can make your training program more effective:
- The users can go through the training at their own pace, in their own time.
- Training is a mix of interactive components such as quizzes and polls.
- There should be an option to test the learnings of the training.
- Training completion should be monitored
- The program should be consistent for all participants in the organization.
- The program should be designed in multiple language.
- Unlimited users can access the program.
- It should give proven results.
Once you’ve chosen the appropriate training method and delivery, you should begin developing the content of the training. The content should cover all details of the research study and should also be condensed in a way that it’s easily understood by the participants.
The first step is to choose all the research topics that can help researchers and then understand how you can design a program that can cover these topics in the stipulated time. Here are some topics that you can include to train a group that’s conducting research for the first time:
- Scope of clinical research
- HIPAA compliances
- Good Clinical Practice by ICH
- Importance of diversity in clinical trials
- Deviations, safety concerns, AEs, and non-compliance
- How to monitor clinical trials
- Financial management related to the study
- Readiness for FDA approval
- How to use EDC clinical trial software
In addition to these things, the training program should cover all the latest tools used for efficient research and all the industry-specific compliances. More importantly, the training program should be created and deployed by industry experts who have extensive research experience.
If you want to make your research study a success, you should make sure to train all your participants on all the latest electronic data capturing (EDC) tools. At ClinicalPURSUIT, we provide high-quality, HIPAA-compliant clinical trial data management solutions including EDC systems for clinical trials.