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GCP Certificate
- 1. GENERAL MANAGER –TRAININGTRAINING COORDINATOR Date of Issue: 16 May 2016 Contact: 011 274 9200 or training@academicadvance.co.za GOOD CLINICAL PRACTICE Basic Course Mr R Botha attended the course and achieved 98% for the assessment 11 & 12 May 2016 Venue: Wits Health Consortium, 8 Blackwood Ave, PARKTOWN Facilitator: Mary-Anne Bopape COURSE CONTENT: Drug Development Process Historical Review of GCP South African GCP Regulatory process in South Africa Study Documents Patient Recruitment and Retention Informed Consent Investigational Product Safety Reporting Responsibility of the Study Team Standard Operating Procedures Laboratory Issues Monitoring Audits The Health Professions Council of South Africa approved CPD reference is as follows: MDB08/141/01/2016 Activity No: 34598 Category: 1B Points: 11 MDB08/140/01/2016 Activity No: 34599 Category: 2L Points: 4 Ethics This 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 A division of Wits Health Consortium (Pty) Ltd COURSE CONTENT: ICH E6 Guidelines for Good Clinical Practice SA Good Clinical Practice Guidelines – 2nd Edition 2006 Drug Development Process Historical Review of GCP South African GCP Regulatory process in South Africa Study Documents Patient Recruitment and Retention Informed Consent Investigational Product Safety Reporting Responsibility of the Study Team Standard Operating Procedures Laboratory Issues Monitoring Audits