Consent and eligibility for Clinical Trials: Learning Burst 4

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Presentation transcript:

Consent and eligibility for Clinical Trials: Learning Burst 4 Mr Karl Ward, Lead Nurse – Research and Innovation Leeds Teaching Hospitals NHS Trust

Why is this relevant… To demonstrate that all trial participants were consented prior to any trial related activity and to evidence that eligibility was confirmed prior to dosing with Investigational Medicinal Product These steps must be fully documented at source and on the Case Report Form (CRF)

Why is this relevant… As an investigator or delegated member of the team you are responsible for ensuring that approved informed consent process is followed at your site This includes the confirmation and review of eligibility in accordance with Good Clinical Practice (GCP), the approved protocol and local policy