Good Clinical Practices Implementation and Auditing Training

RFQ/OBP319/2025/26

Training Provider & Facilitator Accreditation: Look for courses accredited by HPCSA, SAHPRA or SAMAREC (South African Medical Association Research Ethics Committee). Compliance: Courses must cover the latest ICH GCP E6 (currently R3) and South African guidelines. Validity: A South African GCP certificate is valid for 3 years. Training Format: Interactive sessions with a live accredited facilitator (in person classroom set-up) At least 10 years’ experience in offering GCP training Course duration: To be provided by service provider Course content shall include: • Proportionality and Risk-Based Quality Management: The guideline promotes a "fit for purpose" approach, requiring that the level of quality management and risk assessment be proportionate to the specific objectives and nature of each clinical trial. - Flexibility for Modern Trials: E6(R3) supports diverse and modern trial designs, including decentralized models and the use of electronic data capture, promoting innovation and technological advancements. - Clear Roles and Responsibilities: The guidance provides more explicit details on the roles and responsibilities of the sponsor and the investigator, emphasizing clear delegation and overall accountability. - Focus on Data Integrity: Sponsors are required to implement robust data management systems to ensure the reliability and integrity of data throughout the entire trial lifecycle. - Integration of Digital Technologies: The guideline encourages the seamless incorporation of new technologies, such as electronic informed consent and remote monitoring, to streamline trial processes and enhance participant engagement. Implementation and Impact • Global Adoption: Major regulatory bodies, including the FDA in the US and the EMA in Europe, have aligned with the new guidelines and are proceeding with their implementation. - Impact on Stakeholders: Sponsors and investigators must update their strategies and protocols to align with the new expectations, ensuring compliance and the successful integration of new technologies and processes. • GCP auditing.

Request for Quote

2026/01/25 15:00:00

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RFQ/OBP319/2025/26