The basic GCP course provides an overview of clinical research, various concepts of research, and an introduction to Good Clinical Practice (GCP) from a local and international perspective.
It provides an in-depth understanding of the Investigator and team’s competencies and responsibilities as set out in the various guidelines and regulations. The importance of participant protection and valid, credible data within the environment of clinical trials is highlighted. The course is based on the current SA GCP; ICH GCP and other relevant national and international guidelines and regulations.
CREDE GCP courses comply to the SAHPRA and NHREC guidance on GCP training.
Course Format and Structure and Dates
- The course is facilitated via the ZOOM virtual platform and requires live virtual attendance in real-time (one full day).
- At least 1 scheduled date per month, right through the year.
There are 3 components to the GCP basic course:
- Pre-reading of course material provided by CREDE forms an essential component of the course. The material is carefully designed and curated to provide a framework for the live component. Material includes case scenarios, links and presentations, and e-copies of important guidelines.
- The live component takes place virtually, which allows for multiple course participants to join live in an interactive environment. The facilitator guides the discussions and all course participants are encouraged to engage actively.
- A post-course test, as required for certification, is completed within 24 hours by individual course participants. The test is online and open book.
What technology will I need for the virtual class?
You will require internet access, a laptop or desktop computer, and working sound and microphone. A camera is optional but recommended. The ZOOM application must be downloaded on your computer.
How long will this take?
The live component will take over one full day from 08h15 to 16h00. Please allow the equivalent of at least a day’s preparation with the pre-reading course material. These resources will be made available to participants at least a week before the webinar.
GCP certification and CPD
Upon successful completion of the course, the facilitator will email you your GCP certificate, valid for 3 years. Certification acknowledges 2 days of GCP training (preparation & virtual attendance).
Certification is dependent on full attendance and engagement, pre-reading, and the post-course test.
CPD points are organised through the HPCSA accreditation process for 17 CEU’s (4 ethics).
The ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
Cost
The cost for the CREDE GCP beginner webinar course includes the e-material, the facilitation, CPD certification & points valid for 2 years, as well as GCP certification valid for 3 years.