Subject safety and the collection of quality data are the key objectives in any legislation or guidelines related to clinical trials anywhere in the world. A proper understanding and execution of the safety reporting and Investigational Product (IP) handling process is therefore necessary to achieve these objectives. After having ensured a common understanding of the applicable legislations, guidelines and safety and IP definitions in the introduction, this TRIUM Training will focus on the responsibilities of the key stakeholders (investigator, sponsor & monitor, applicable ethics and regulatory body) and the processes to follow to ensure oversight and compliance. For example, the full circle from investigator to sponsor to regulatory body back to the sponsor and the investigator for safety reporting and the road an IP takes from manufacturing to destruction will be explained in detail.
Case studies, opportunities for discussion and exercises are part of the design to ensure proper understanding of each key stakeholder’s part in the process, for knowledge and skills retention and fast transformation of the content into practical application.
At the end, you will receive a certificate and handy hand-outs for use in the field.
By the end of this TRIUM Training you should be able to:
- List the global legislation and guidelines regulating the safety reporting and IP handling procedures
- Define safety reporting definitions
- List the research stakeholders involved in safety reporting and IP handling
- Investigator, sponsor, applicable ethics and regulatory body responsibilities related to safety reporting and IP handling
- Monitoring responsibilities and activities to ensure qualitative safety reporting and IP handling
- Describe the safety reporting cycle and the difference between medical devices and pharma/biotech safety reporting processes
- Conduct compliant safety reporting and IP handling per your research role
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.