Adverse Event (AE) Assessment & Grading for Clinical Research Practitioners (CRPs) and senior Clinical Trial assistants (sCTAs): Ensuring Patient Safety in Clinical Drug Trials
Loading...
All Authors
Drew, Victoria
LTHT Author
Drew, Victoria
LTHT Department
Research & Innovation
Non Medic
Senior Clinical Educator (Research)
Publication Date
2025-07-10
Item Type
Conference Abstract
Language
en
Subject
Subject Headings
Abstract
Background:
Patients in Clinical Research are protected through the assessment and reporting of AEs (ONS, 2016). Inaccurate reporting of AEs can lead clinicians making inappropriate decisions (Zhang et al., 2016). Clinical Research Nurses (CRNs) are integral to the AE reporting process within trials (Catania, 2012), yet a recent local training analysis and review of the current literature yielded no results around this area of training and education. CRPs and sCTAs now undertake tasks historically done by CRNs (NIHR, 2025), including assessing AEs, which highlighted an important training need within our organisation, leading to the development of a specific training programme.
Aims of the taught session:
• Understand AE assessment and terminology
• Understand how to accurately grade AEs
• Increase confidence in using the Common Terminology Criteria for Adverse Events (CTCAE)
• Know when to escalate AEs
Methods:
A training programme involving a taught session and competency document, was developed and subsequently piloted. A group of 5 CRPs/sCTA were selected for the taught element of the programme, which was evaluated with pre and post training questionnaires, to determine confidence and understanding linked to the aims and objectives of the programme.
Results:
Five staff completed the pre-questionnaire, and 4 completed the post-questionnaire. Prior to the session, none had received formal AE assessment training, 3 had received informal training and 3 had used the CTCAE before. The post training questionnaire showed that there was an increase in confidence using the CTCAE, assessing AEs, and understanding the terminology used, for 3/4 staff.
Conclusion:
The training has increased the knowledge and confidence for 3 out of the 4 staff who completed the post-training questionnaire compared to the pre-questionnaire. This will provide a standard approach to AE assessment and grading.
The training will be updated from feedback received and made available to all staff who are delegated AE assessment in their role.