The Future of Modern Clinical Trials is Here: Join the Advanced Clinical Investigator Certification (CLIC) Course 2026
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Advance Your Clinical Research Expertise with South Africa's Leading Clinical Investigator Training Programme
Date: 13 Aug -16 Sept 2026
Hybrid programme | face-to-face and virtual delivery | Cape Town, South Africa
The clinical research landscape is evolving rapidly. With the implementation of ICH E6(R3), the growing adoption of decentralised and data-driven trial models, increasing regulatory expectations, and the emergence of Artificial Intelligence (AI) in clinical research, today's investigators and site staff require a new level of knowledge and competence.
For the past decade, Fundisa African Academy of Medicines Development and Tiervlei Trial Centre have successfully delivered the Clinical Investigator Certification (CLIC) Programme. Building on this strong foundation, the Advanced Clinical Investigator Certification (CLIC) Course 2026 has been designed to prepare investigators, study coordinators, site personnel, pharmacists, regulators, and healthcare professionals for the future of clinical research.
Why Attend?
The Advanced CLIC Course provides practical, contemporary training aligned with:
• ICH E6 (R3)
• ICH E8 (R1)
• South African GCP 2020
• South African National Department of Health (NDoH) 2024 Guidelines
Participants will gain a comprehensive understanding of:
✓ Advanced Good Clinical Practice (GCP)
✓ Quality by Design (QbD)✓ Risk-Based Quality Management (RBQM)
✓ Critical-to-Quality (CTQ) Factors
✓ Digitalisation of Clinical Trial Sites
✓ Artificial Intelligence in Clinical Research
✓Community Engagement and Diversity
✓ Leadership and Quality Culture
✓ Regulatory Compliance and Data Integrity
Importantly, training on the NDoH 2024 Guidelines, referenced in SA GCP 2020, is increasingly expected by ethics committees and stakeholders across South Africa.
Programme Details
Dates: 13 August – 16 September 2026
Delivery Format: Hybrid Programme
• Face-to-face sessions in Cape Town
• Live virtual participation available
• No recordings provided
Module 1
Foundations of Modern GCP and Evolving Ethics
13 August 2026 | 08:00 – 17:00 SAST | Hybrid
Topics include:
The Evolution of Ethics in Research in the Context of ICH E6(R3)
Overview of Medicines Development: The Global Regulatory Landscape
Introduction to ICH E6(R3): Patient-Centricity, Proportionality and Flexibility
ICH E8(R1): Quality by Design, Critical-to-Quality Factors and Inclusivity in Trial Design
Ethics and Regulatory Frameworks: NDoH 2024 Guidelines and SA-GCP 2020
Module 2
Operational Excellence at Trial Sites
14 August 2026 | 08:00 – 17:00 SAST | Hybrid
Topics include:
Clinical Trial Site Competence
Clinical Operations Process Standardization
Modern Informed Consent and e-Consent
Safety Reporting
Risk-Based Sample Lifecycle Management
Investigational Product Management
Essential Records and Documentation for Data Integrity
Presented by Dr Zarinah Mohamed, Dr Haylene Nell, Prof Nobelungu Ngoloyi-Mekwa, Dr Tirhani Maluleke, Prof Patrick Bouic, Shaakira Abrahams and Dr Annalene Nel.
Module 3
Protocols and Data Reliability
19 August 2026 | 15:00 – 17:00 SAST | Virtual
Study Protocol Harmonisation: ICH M11 (CeSHarP)
Reliable Data for Clinical Technical Documents
Presented by Dr Haylene Nell and Dr Annalene Nel.
Module 4
Digitalisation and Data Governance
26 August 2026 | 15:00 – 17:00 SAST | Virtual
Digitalization of Clinical Trial Sites
e-Source and e-CTMS
Remote Monitoring
Decentralized Trial Models
Data Governance and Transparency
Presented by Marius Engelbrecht and Adriaan Kruger.
Module 5
AI in Clinical Trials
2 September 2026 | 15:00 – 17:00 SAST | Virtual
Good AI Practice in Clinical Research
AI in Clinical Trial Operations
Practical AI Use Cases
Implementation Readiness
Presented by Prof Keymanthri Moodley and Adriaan Kruger.
Module 6
Community Engagement, Diversity and Compliance
9 September 2026 | 15:00 – 17:00 SAST | Virtual
• Participant-Centred Community Engagement
• Inclusive Research Approaches
• Contracts and Stakeholder Agreements
• Insurance and Legal Essentials
Presented by Dr Annalene Nel and Johan Heyns.
Module 7
Leadership and Risk-Based Quality Management
16 September 2026 | 15:00 – 17:00 SAST | Virtual
• Building Quality Culture
• Leadership and Resilience
• Future-Ready Clinical Research Teams
• Risk-Based Quality Management
• Clinical Quality Management Systems (CQMS)
Presented by Renata Schoeman and Dr Annalene Nel.
Registration Options
Option I – Modern Clinical Trial Operations
Modules 1 & 2 (On-site Cape Town)
Standard Fee: R6,000
Early Bird Fee: R5,000
Modules 1 & 2 (Virtual)
Standard Fee: R5,000
Early Bird Fee: R4,000
Option II – Modern Clinical Trials Advanced
Modules 3–7 (Virtual)
Standard Fee: R7,000
Early Bird Fee: R5,000
Option III – Full Advanced CLIC Certification
Modules 1–7 (Hybrid)
Standard Fee: R12,000
Early Bird Fee: R10,000
Modules 1–7 (Virtual)
Standard Fee: R10,000
Early Bird Fee: R8,000
Who Should Attend?
This programme is ideal for:
• Principal Investigators • Sub-Investigators • Study Coordinators • Clinical Research Nurses • Site Managers • Pharmacists • Clinical Research Associates • Regulatory Professionals • Sponsors and CRO Personnel • Ethics Committee Members • Healthcare Professionals involved in research
Secure Your Place Today
The future of clinical research belongs to professionals who understand modern GCP, quality-focused trial design, digital transformation, AI implementation, and participant-centered research.
The Advanced Clinical Investigator Certification (CLIC) Course 2026 offers an exceptional opportunity to learn from recognized experts while building practical skills that can be immediately applied in clinical trial settings.
Join a growing network of clinical research professionals committed to advancing research quality, participant safety, regulatory excellence, and innovation.
The Future of Modern Clinical Trials is Here.
Register today and become part of the next generation of clinical research leaders.
**CPD accreditation and registration deadline: to be confirmed
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