GCP training refers to Good Clinical Practice training, a critical foundational course designed to educate individuals in clinical research on the ethical, safe and scientific quality standards for how to design, conduct, record and report data in clinical trials that involve human participants as part of interventional clinical trials (i.e. testing new medicine) and device trials.

If you’re considering a career in clinical trials or need to ensure compliance within your organisation, understanding GCP is non-negotiable. But what is GCP training, and why is it necessary?

More importantly, how can you get the training you need to thrive in South Africa’s clinical research landscape?

This blog has all the answers.

Whether you’re just starting your clinical research career or looking to upskill for compliance, this guide covers the essentials of GCP training, its purpose, who it’s for, and the guidelines unique to South Africa.

Plus, we’ll introduce you to TASK Research Academy’s (TRA) robust combined first-time GCP Training and SA GCP Workshop and our GCP refresher Course to ensure compliance every three years.

what is gcp training

 

Understanding GCP and GCP Training

What is GCP?

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality standards for how to design, conduct, and report in clinical trials globally to protect participants’ rights, safety, and well-being.

It’s the ethical and operational roadmap for research that generates high-quality, credible and accurate data that adheres to international standards.

GCP builds global trust in clinical research and helps ensure that every participant is protected and every data point is reliable, regardless of country.

International and Local Guidelines: ICH GCP and SA GCP

There are two sets of GCP guidelines: International and Local.

1. ICH GCP (International Council for Harmonisation – Good Clinical Practice)

  • These are global standards developed to harmonise regulatory requirements across regions like the US, EU, and Japan.
  • Widely adopted as the core standard for GCP worldwide.
  • Applicable to all interventional clinical trials intended for regulatory submission.

Download the ICH CGP guidelines here.

2. Local Guidelines, e.g., SA GCP (South African GCP)

  • Country-specific adaptations of GCP, like South Africa’s SA GCP, provide more detailed guidance that reflects local laws, ethics, infrastructure, and regulatory requirements.
  • SA GCP is published by the Department of Health in South Africa and aligns with ICH GCP, but also includes additional requirements specific to the South African context (e.g., community engagement, ethics review, language considerations).

Download the latest SA GCP 2020 guidelines here.

ICH GCP provides the foundation, but local guidelines, such as SA GCP, ensure that international principles are applied in a manner that makes sense in the local legal, cultural, and healthcare environment.

Local guidelines are important for compliance with national laws and ethical standards specific to a country or region.

What is GCP training?

GCP training equips clinical trial staff – including researchers, investigators, and coordinators – with the knowledge they need to comply with these principles. It covers essential topics such as participant safety, data integrity, ethical considerations, and regulatory requirements.

For countries like South Africa, GCP training also includes local requirements to ensure national standards are met.

Why Train on Both ICH GCP and SA GCP?

If you’re conducting or involved in internationally sponsored or regulated trials, you must understand ICH GCP to meet global regulatory standards.

If you’re conducting research within South Africa, especially involving local ethics review and approval by SAHPRA, you must also understand the SA GCP to comply with national requirements.

If you’re conducting clinical trials in South Africa, you need training on both to ensure ethical, scientific, and regulatory compliance. Most South African training programs, like that of TASK Research Academy, include both sets of guidelines to ensure researchers are fully equipped.

Why You Need GCP Training

Organisations that value ethical, scientifically sound research that is globally harmonised in terms of design, conduct and the collection and reporting of standardised and credible data accepted by global regulatory authorities and trusted by the public know that staff trained in GCP lead to successful trials. Conducting clinical research without properly trained teams is a recipe for disaster.

Here are some of the risks of hiring untrained staff:

  • Non-compliance with global and local laws and regulations can lead to potential legal repercussions.
  • Poor-quality data renders studies invalid or unpublishable.
  • Significant risks to participant health and safety.

Investing in GCP training ensures your team is equipped to handle these challenges. It sets a strong foundation for ethical decision-making and successful trials.

Who Needs GCP Training?

If you’re involved in clinical research or anticipating entering the world of clinical trials, chances are high that you need GCP training.

Key Roles That Require GCP Training:

  • Clinical researchers and Principal investigators: These individuals oversee trials and must adhere to rigorous ethical and scientific standards as they are responsible for the overall conduct of the trial at the site.
  • Sub-Investigators: Assist the PI with clinical and research tasks.
  • Trial site staff and Study coordinators: They manage day-to-day trial operations, participant visits, and documentation, making their GCP compliance vital for overall trial integrity.
  • Clinical Research Associates (CRA) / Monitors: Remote /Central and on-site CRAs monitor trial conduct, verify data accuracy, and ensure site compliance.
  • Study sponsors and service providers, e.g CRO’s: These professionals oversee the trial from protocol development to study close-out and must ensure trials are conducted under ethically sound conditions and meet regulatory standards.
  • Ethics committee members: Their decisions on trial approvals hinge on a solid understanding of GCP principles.

Essentially, GCP training is not limited to this list. Even if you’re not directly interacting with participants, if your role affects trial data, safety, or compliance, GCP training is a must-have.

GCP Guidelines in South Africa

South Africa’s GCP guidelines are unique and enforced by the South African Health Products Regulatory Authority (SAHPRA).

If you’re working or aiming to work in clinical trials in South Africa, here’s what you need to know about first-time GCP training:

  • First-time GCP training must follow SAHPRA standards and is effective from 1 June 2024 ongoing.
  • The guideline states that your GCP training must not just include ICH GCP, but also include training on SA GCP – reflective on your certification.
  • Virtual Training Approved: Although the current SA GCP third edition 2020 guideline prescribes face-to-face training, the guideline clarified that your GCP training must include a virtually led face-to-face session via platforms like Zoom or Teams. Sessions must be interactive, providing opportunities for participants to actively engage. A live facilitator must be present throughout for questions and discussions.
  • Mandatory Two-Day Training: The course must align with prescribed outcomes and unit standards and last approximately two days.
  • Accreditation: The training content must be accredited by the Health Professions Council of South Africa (HPCSA).
  • Certificates are valid for 3 years, after which you can maintain compliance through online ICH & SA GCP courses.

What Doesn’t Qualify

South Africa has strict standards concerning first-time GCP training. Many hopeful candidates have tried using free online GCP certifications from international platforms, but these don’t meet South African requirements.

Here’s why:

  • They don’t cover SA-specific GCP guidelines (ICH GCP isn’t enough).
  • They are often too short (less than the recommended two days).
  • No live facilitator engagement is provided.
  • They are not accredited by the HPCSA.

Without meeting these vital requirements, candidates may find themselves ineligible for roles in South Africa’s clinical research field.

Getting Started With TRA‘s GCP Training Course

If you’re seeking GCP certification in South Africa, look no further than TASK Research Academy. Our training courses and workshops are carefully designed to meet all the SAHPRA requirements and set you up for success.

Why Choose TRA?

Here’s what TASK Research Academy’s GCP Training offers:

1. Comprehensive Two-Part Structure

The course is based on a mock clinical trial and is divided into two parts: Part 1, a 10-hour asynchronous (online) course with interactive and engaging material that you can do in your own time and at your own pace in the comfort of your own home. To prepare you for Part 2, the attendance of the mandatory virtual face-to-face SA GCP workshop, facilitated by a GCP expert, totalling a 16-hour GCP learning journey, ensures a working knowledge of GCP guidelines in clinical trials.

2. SAHPRA-Compliant

TRA’s training complies with the guidelines for first-time GCP training as mandated by SAHPRA and is accredited by the HPCSA. It includes both ICH GCP and SA-specific GCP guidelines to meet national standards.

3. Interactive Virtual Workshops

Learn online from anywhere. Attendance to one mandatory SA GCP face-to-face component is made easy. Our scheduled workshops are live (virtual), interactive and led by an experienced facilitator, providing immersive discussion points on real-life scenarios and support for questions throughout.

4. Valid Certification

Once you complete your first-time GCP training through TRA, your certificate is valid for three years (with a three-month grace period after expiry, to renew). To maintain GCP compliance, we offer an online GCP Refresher course to keep your working knowledge in the industry up to date.

5. Our training goes BEYOND GCP compliance!

Our full first-time GCP training course- Foundations and Beyond – not only delivers GCP compliance (on both SA GCP and ICH GCP guidelines) but provides in-depth and immersive insight into the full life-cycle of a clinical trial, from start-up to close-out, including all role players involved and what their responsibilities are from a bird’s eye view.

This course equips staff with a working knowledge of clinical trial conduct by means of interactive and simulation training techniques, based on a mock Phase III clinical trial, including an introduction to:

  • Example documents
  • Real-life scenarios
  • Quizzes to develop staff’s decision-making skills as they would at the site

We teach what to do, how to do it, when to do it, and why it should be done, in line with GCP guidelines.

Workshop Dates

Check out upcoming workshop dates and secure your spot today.

GCp training TRA part 2 workshop dates

Contact us at task.academy@taskclinical.com or call us on +27 21 100 3606.

Start Your GCP Training Journey With Us

Good Clinical Practice Starts Here!

GCP training is not just a regulatory box to tick; it’s the backbone of ethical, effective clinical research and your ticket to enter the clinical research industry! By understanding these principles, you can contribute to advancing healthcare while safeguarding the well-being of trial participants.

At TRA, we don’t just meet the requirements; we exceed them, ensuring you and your team are empowered to excel in clinical research.

Don’t wait to take the first step toward professional growth.

Register for TASK Research Academy’s First-Time GCP Training Course, Foundations and Beyond, or our GCP refresher course today and set yourself apart in the world of clinical research.