The Informed Consent process, Quality Control and Protocol Compliance in Clinical Trials

Description
Operational

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.

Learning objectives

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
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
Bert Peeters
Bert Peeters has a Master degree in Biomedical Sciences and obtain a Specialization in Management and Policy in Healthcare. He has over 15 years of experience in the clinical research industry, 10 of which have been in a QA related role at several CROs. He has a thorough understanding of clinical trial processes together with in-depth knowledge of ICH-GCP / ISO 14155 guidelines and excellent understanding of regulatory requirements, combined with QA management and auditing experience. Since 2020, Bert is TRIUM’s Quality Assurance Manager.