16.01.2024
Safety Data Reporting
The course focuses on safety data reporting in paediatric clinical trials, following Good Clinical Practice and Good Pharmacovigilance Practice guidelines.
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Ethics Committee Evaluation of Paediatric Clinical Trials
This course focuses on the evaluation of paediatric clinical trials by an Ethics Committee, following the guidelines of Good Clinical Practice.
Show more06.07.2023
Trial Start Up
This course provides a general overview of activities required to start paediatric clinical trials in sites, in line with international and European standards, taking into account the specific guidelines for trials involving children.
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The Role of Research Nurses
The course focuses on the role of Research Nurses in paediatric clinical trials.
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Obtaining Informed Consent & Assent
This course focuses on the process to obtain informed consent and assent during paediatric clinical trials.
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Monitoring Paediatric Trials
This course focuses on the monitoring aspects of paediatric clinical trials, including the role of the monitor (CRA), site staff responsibilities, monitoring plans and study specific procedures (SSP).
Show more06.07.2023
Essential Documents
The course is designed to familiarise you with the essential documents needed for a Clinical Trial, following the guidelines of Good Clinical Practice.
Show more06.07.2023
Audit & Inspection Readiness
This course is on how an inspection (or an audit) should be prepared for and conducted by staff of a clinical trial site.
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