Scope of Services
- CTU provides a supportive environment to conduct clinical trials in a cost-effective and efficient manner while ensuring compliance with clinical trials standard operating procedures, Good Clinical Practice (GCP), CCHE Institutional Review Board (IRB), external regulatory agencies and external sponsors.
- Establishes and maintains appropriate administrative support for the development and implementation of clinical trials.
- Provides disease management teams with regulatory support to ensure compliance with GCP, IRB and other regulatory agencies.
- Ensures safety of patients with rapid actions in case of unexpected events during any of the ongoing studies.
- Supports IRB in executing the functions of the clinical trial Review and Monitoring System.
- Disseminates information on active clinical trials involving cancer patients to the hospital staff and patients at CCHE.
- Provides education and training for CCHE staff involved in clinical trials regarding the importance of clinical trials and its ethical and regulatory issues.