As the clinical research industry evolves, it is essential to continually acquire knowledge and skills to remain competent in the field. Pharmaceutical companies, regulatory bodies, sponsors, ,and contract research organisations (CROs) should support institutions in developing training programs to facilitate continuous education and ensure a competent workforce. In this blog, we will explore the various training modules that can help research staff remain “fit for purpose” in a dynamic environment.
Review of Literature:
One of the most effective methods of maintaining up-to-date knowledge in clinical research is through literature review. Research staff can visit relevant websites regularly and subscribe to automated notifications for updates. Periodic sessions (once a month) can be organised to share new information and updates with other staff. Group discussions can help to reinforce the information and sharpen awareness to a greater extent.
Review of Audit Reports:
Audit reports can also provide insights into essential findings or particular audit situations, and research staff can analyse them in a group or workshop setting. This can help other staff or sites become aware of critical findings and understand how to prevent them in the future.
Site Training Workshops:
Audit scenarios or situations extracted from audit reports or literature on the latest regulations can form the basis for case studies in training workshops. For example, guidelines on completing the FDA 1572 can be interpreted and implemented in a standard format across sponsor, CRO, and sites. These topics and findings can be used for comprehensive training.
Immersive Learning Opportunities:
Many sites may be isolated, and research staff may not have the opportunity to work closely with experienced professionals. Others may have been operating for a while but have never been exposed to an audit and are unsure if they are meeting expectations. Industry support to fund training programs can help inexperienced staff shadow and learn from experienced sites. We need to bridge the Good Clinical Practice (GCP) gap by creating continuous learning opportunities for the new generation.
Clinical research staff must be trained continually to remain adept and successful in their work environment. The return on investment will be high, including a competent workforce, higher quality trials, accurate data output, and infrequent personnel changes. Although GCP is clear on the requirement for training, it is not clear on what and how to train. Therefore, sponsor, CRO, and site management should pay attention to developing staff skills, and training should be equally dynamic as the industry itself. Investing in developing clinical research staff is vital, and it is an investment that will pay off.
Foundations and Beyond – the clinical research journey
An excellent opportunity for Pharmaceutical companies, regulatory bodies, sponsors, and contract research organisations (CROs) to support training programs is to support or fund the enrollment of industry professionals into the “Foundations and Beyond – the Clinical Research Journey”course, to help clinical research professionals bridge the gap between initial GCP training and real-life scenarios. The course is based on the full life cycle of a mock Phase III clinical trial and aims to help learners gain the necessary confidence, skills and practical knowledge to understand the bigger picture and succeed in the clinical research industry.