In recent developments, the South African Health Products Regulatory Authority (SAHPRA) and the National Health Research Ethics Council (NHREC) have made significant strides in updating their guidelines to acknowledge, support, and accept virtual training for first-time Good Clinical Practice (GCP) training. This pivotal decision marks a progressive shift in the landscape of clinical research education within South Africa.

Introduction and Background

The COVID-19 pandemic prompted unprecedented challenges for various industries, including the clinical research sector in South Africa. In response to these challenges, SAHPRA, in collaboration with the National Department of Health (NDOH) and NHREC, extended a gracious accommodation to the clinical research industry, allowing for the provision of basic / first-time GCP training through virtual classrooms. However, a review was underway to potentially revert to traditional, in-person face-to-face training, as outlined in the SA GCP section 4.4.3.10.

Recognizing the evolving landscape of education and training, it was imperative to consider the most effective methods for delivering first-time GCP training. While traditional face-to-face training has been the norm, virtual classroom training presents a viable alternative that aligns with modern educational principles and industry demands.

What is Virtual Classroom Training?

Virtual classroom training is a form of synchronous online learning that facilitates real-time interaction between instructors/facilitators and students. Leveraging digital tools such as learning management systems and video conferencing platforms, virtual training simulates the immersive experience of traditional classroom settings.

Benefits of Virtual Classroom Training:

  1. Increases Inclusivity: Virtual classes provide a safe space for reserved students to actively participate without the anxiety associated with traditional classroom settings.
  2. Improves Accessibility: Virtual training eliminates geographical barriers, enabling students from remote locations to access high-quality education.
  3. Facilitates Collaboration and Community Building: Virtual classrooms foster an inclusive online community where students can interact and collaborate beyond the confines of physical classrooms.
  4. Cost Saving: By eliminating the need for venue rentals, refreshments, and travel expenses, virtual training offers a cost-effective alternative to in-person sessions.
  5. Enhances Technical Skills: Virtual classrooms expose students to various interactive technologies, fostering the development of essential technical skills.
  6. Provides Immediate Feedback: Live quizzes, polls, the opportunity to ask questions directly to the facilitator and online exams offer real-time feedback to students and instructors which enables them to gauge students’ understanding instantly.
  7. Greater Flexibility and Comfort: Virtual courses can be offered more frequently, accommodating diverse schedules and preferences.

Virtual Face-to-Face first-time GCP Training also aligns with the World Health Organization’s (WHO) Competency Framework

Virtual training effectively addresses the six domains outlined in the WHO Competency Framework by integrating interactive learning activities that promote people-centeredness, decision-making, communication, collaboration, evidence-informed practice, and personal conduct.

Consequences of face-to face GCP training to the South African Clinical Research Industry

Reverting to exclusively in-person face-to-face first-time GCP training poses significant challenges and limitations for the clinical research industry in South Africa. It impacts cost, accessibility, capacity building, diversification efforts, and overall workforce readiness, ultimately hindering the growth and sustainability of clinical research endeavours within the country.

The Current Landscape

The clinical research industry in South Africa is facing a workforce crisis, exacerbated by the challenges posed by the COVID-19 pandemic. SAHPRA’s recent strides in expediting approval processes underscore the importance of embracing innovative approaches to training and capacity building.

The acceptance of virtual training for first-time GCP compliance by SAHPRA and NHREC heralds a new era of education and training in the South African clinical research industry. Virtual classroom training offers a dynamic, inclusive, and cost-effective solution that aligns with global trends and industry demands. By embracing virtual training, stakeholders can ensure the continued growth and success of clinical research endeavours in South Africa.

TASK Research Academy’s (TRA) New GCP Training Program

In compliance with the updated regulations, TRA is launching a Qualified GCP facilitator-led live and interactive virtual workshop, complemented by a foundational pre-workshop course. This comprehensive program ensures participants are ICH and SA GCP compliant, equipped to excel in their clinical research roles.

For further information on the two part program, workshop dates or enrollment details, please visit our website or contact us at academy@task.org.za.