Every year for at least the last 20 years, Informed Consent Form (ICF) issues and protocol compliance breaches are listed in the top 10 of most common EMA inspection findings. On top of this, in about 50% of the cases these findings are categorized as critical or major. If you want to avoid this kind of inspection feedback and ensure patient safety as well as quality of data for your trial, this TRIUM Training will set you well on your way. Each step of the ICF process from each stakeholders’ perspective (sponsor, investigator, IRB/EC) will be covered in detail, from writing the ICF to handing over a copy of the signed ICF form to the subject involved. Next to an introduction of Quality Assurance (QA) and Quality Control (QC) requirements, you will learn key QC skills (both for sponsors and sites) ensuring ongoing quality in your trial. Finally, tips and tricks on how to help sites ensure protocol compliance will be shared.
Case studies, opportunities for discussion and exercises are part of the design to ensure proper understanding of how to conduct trending, creating compliance plans, setting KPI’s and early warning detectors, for knowledge and skills retention and fast transformation of the content into practical application.
At the end, you will receive a certificate for attendance 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 ICF process, QC in clinical trials and protocol compliance
- Define and apply the ICF process in any clinical trial
- Define QC in clinical trials
- Conduct QC activities for your role in research like KPI and early warning indicator setting, compliance planning and trending
- Support your site in protocol compliance by applying the tricks and tips learned
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.