OCTRU Pharmacovigilance Workshop *ONLINE*
Joanna Black
OCTRU
Tuesday, 08 February 2022, 10am to 4pm
Hosted by octrutrialshub@ndorms.ox.ac.uk
Workshop key objectives:
Understanding the terms diagnosis, signs and symptoms; and investigations
Assessment of causality: the rules within the framework
Assessment of expectation: when is an event considered expected?
Downgrading of SUSARs: when is this allowed?
Query of SAEs
Interpretation of the RSI
Managing updates to the RSI
Coding and the use of MedDRA
Working through some real examples of SAEs
Note: the workshop is focused on CTIMPs, but several aspects of this are relevant to nonCTIMPs. It will
not cover the rules for Medical Device trials.
To book your place, please email octrutrialshub@ndorms.ox.ac.uk
External Training
These links lead to a variety of clinical research related resources, training opportunities and conferences offered by external organisations – OCTRU does not necessarily endorse the links – this is offered only as a resource for individuals to use when looking for wider opportunities.
Note: We endeavour to keep this page up to date, however if a link is broken please can you let the admin team know on octrutrialshub@ndorms.ox.ac.uk
Training Opportunities
Training provided in Clinical Trials by the University of Oxford
Training in Research Integrity & Ethics
Research Governance, Ethics & Assurance Team (RGEA)
UKCRC Registered Clinical Trial Units
Monitoring of clinical trials - Online Training Modules
Resources about Human Tissue Act
Resources about Public Engagement
Health Research Authority (HRA)
National Institute of Health Research (NIHR) including NIHR Learn
Integrated Research Application System (IRAS)
NIHR Research & Design Services (RDS South Central)
This team have regular emails with links to training opportunities offered by themselves and other – follow this LINK to register for these alerts.
NIHR Learning for Involvement - training and resources dedicated to learning and development for public involvement in health and social care research
NIHR Associate Principal Investigator Scheme Resources Site
E-Learning
Training offered on Good Research Practice, including GDPR, Human Tissue legislation, IRAS - follow this LINK
National Institute of Health Research (NIHR Learn)
Online training courses for those working on trials, including those with an ac.uk email address. Courses include Introduction to GCP and refresher GCP training, diversity and inclusion training, and more - follow this LINK
LinkedIn Learning
Conferences
Biannual conference for researchers and practitioners to present the very latest in trials methodology research
Society for Clinical Trials (US organisation)
Annual conference in the US for those working in trials