Safety Reporting, Investigational Product Handling and Monitoring in Clinical Trials

Description
Operational

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.

Learning objectives

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
Training design
Classroom Training
Training duration
4 hour
Training Language
English
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Isabelle De Bock
Isabelle De Bock has almost 17 years of clinical research experience in the medical device industry. While she started as an international CRA, Isabelle held many other roles and responsibilities within the clinical landscape varying from project lead and clinical manager to compliance manager responsible for SOP maintenance, training, audit support & inspection readiness. Prior to joining TRIUM in September 2019 as Manager Operations, Isabelle was a dedicated supervisor for about 5 years, managing an international group of monitors and building up from scratch an in-house CRA team, having line management responsibilities for more than 15 employees at once.  Isabelle is used to work in a global environment across different departments & multiple regions around the globe. She holds a master degree in Biology, did 2 years of PhD scholarship at the University of Leuven and obtained a Teacher Degree as well prior to joining the clinical research world.