Big Leap Research, in collaboration with CTC Clinical Training Company, recently organized a structured professional training program for CRCs, CRAs, and CTAs, focusing on ICH-GCP, clinical research operations, and practical site-level support.
The program was designed to strengthen both technical knowledge and operational competencies required for clinical trial implementation. The training covered key topics including ICH-GCP principles, Vietnam Ministry of Health regulations, investigator responsibilities, sponsor and CRA expectations, and the roles of Investigators, SMOs, CRCs, CRAs, and CTAs in study conduct.
Practical sessions addressed important operational areas such as the informed consent process, investigational product management, safety reporting requirements and timelines, essential documents, and Investigator Site File (ISF) management.
Throughout the program, Big Leap Research team members actively participated in discussions and shared practical experiences from clinical research operations. The training provided a valuable opportunity for CRCs, CRAs, and CTAs to enhance their professional knowledge, clarify operational challenges, and strengthen consistency in day-to-day study support activities.
Through this collaboration with CTC Clinical Training Company, Big Leap Research continues to invest in professional development and structured training, ensuring that its clinical operations team remains aligned with ICH-GCP standards, regulatory requirements, and high-quality site-level execution.
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