The planning, preparing, and organising of clinical trials has become a highly complex task that includes important issues such as: the need to protect patients, generate reliable data, perform trials efficiently within short timelines, fulfil quality requirements according to current legislation and inspection requirements, and conduct clinical trials within budget to ensure sustainable business.
Since COVID-19 emerged in 2020, it has caused unprecedented disruption of clinical trials. To protect patient safety and trial integrity, the pharmaceutical industry made strides to accelerate trial innovations such as digital tools and virtualization, with support from regulatory authorities. The increased complexity of medicines development and regulatory requirements require well-trained staff in industry, CROs and Regulatory Agencies. The 2018 SAHPRA draft guidance on “Capacity Building and Transformation in Clinical Trials Research in South Africa” requires public or private clinical trial sites to offer training at all staff levels.
PharmaTrain and the European Clinical Research Infrastructures Network (ECRIN) have developed an international standardised Clinical Investigator Certification (CLIC) Course syllabus as training platform for investigators, site staff as well as regulatory and other scientists. Fundisa Academy African Academy of Medicines Development, together with Tiervlei Trial Centre, have successfully hosted CLIC courses in Cape Town and Johannesburg in line with the PharmaTrain syllabus since 2015.
CLIC LEVEL 1 + SA GCP 2020:
Core knowledge on ethics, quality data, preparation and conduct of studies at investigational sites. The target audience for this two-day programme includes sub/co-investigators, study nurses, and study coordinators.
CPD POINTS: 5 Ethics + 8 Clinical
CLIC LEVEL 2:
Knowledge in regulatory and managerial aspects, according to SA-GCP, international and national requirements. The target audience for this five-day programme includes principal investigators, clinical trial managers, and site managers.
CPD POINTS: 3 Ethics +17 Clinical
If you have questions about the available CPD points, please see a course representative in-person
Hanlie Bester