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Choose Your Training Course
Intro to Good Clinical Practice (GCP)
3 000RThe GCP course is run over 2 days and designed to prepare staff in the conduct of clinical researchValid for 7 days- Principles of Good Clinical Practices
- The Rights And Importance Of Consent Of The Trial Subjects
- International Council For Harmonization
- Establishment of ICH
- Groups Working Within ICH
- Link Between ICH And GCP
- Guidelines of What An Ethical And Safe Trial Is
- The Duties Of The Sponsor And Investigator Of The Trial
- Aims Of ICH
- The Importance Of ICH
- ICH GCP E6 R2 Efficacy Guidelines
- The Institutional Review Board
- Protocol And Protocol Amendment, Investigator’s Brochure
- Essential Documents
Refresher GCP
1 000RThis 1 day course is a revision of Good Clinical Practice (GCP)Valid for 7 days- Summary of GCP - Introduction session
- The development of GCP
- GCP in South Africa
- Audits & Inspections
- Genetic Research Trends
- Litigation in Clinical Trials
- Industry Updates in relation to GCP
Clinical Study Coordinator
10 000RA 1 month course to gain skills and competencies to for an entry career in study coordinationValid for one month- Introduction to Clinical Research
- ICH/GCP and CFR 21
- Clinical Research Process and Study Design
- Clinical Research Organizations, Vendors, Ethic Boards and S
- Study Coordinator and Site Staff
- Protocol and Informed Consent Form (ICF)
- Medical History, Adverse Events/Serious Adverse Events and C
- The Monitor
- CERTIFICATION EXAM
Clinical Research Associate (CRA)
10 000RThis 5 day course is aimed at aspiring clinical research professionalsValid for 7 days- Medicines Development Process, Good Clinical Practice
- Regulatory Environment in the EU and USA
- Clinical Trial Design & Clinical Research Roles & Resp.
- Selecting and Initiating Clinical Trial Sites
- Monitoring and Closing Clinical Trial Sites
- Patient Protection & Adverse Events
- Investigational Medicinal Product Management
- Data Management for Clinical Research Associates
- CERTIFICATION EXAM
Clinical Project Manager (CPM)
14 000RThis 3 month program will certify attendees with knowledge to project manage clinical trialsValid for 3 months- Project Management Basics
- Stakeholder Management
- Project Conception and Definition
- Project Risk Management
- Clinical Risk Management
- Project Planning
- Project Critical Path and Baseline Schedule
- Project Launch and Execution
- Project Closure and Evaluation
- CERTIFICATION EXAM

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