2154 Courses delivered Online

This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and how sponsors should report to regulatory authorities and other stakeholders in the safety of investigational products. It explains how events are characterized as serious or non-serious, expected or unexpected, and it distinguishes the requirements for each category. It describes controlled vocabularies used for coding of events in reports.

A clinical investigator is responsible for conducting the clinical trial in compliance with the study protocol, GCP, medical ethics, and applicable legal requirements. The clinical research community expects that investigators and clinical staff are fully trained in GCP. Duties and functions discussed in this short course include: provision of adequate resources; liaison with IRB/IEC; compliance with protocol; management of investigational product(s), informed consent and data records; and safety reporting.

Unlock the secrets of effective and sustainable weight loss with our comprehensive course, 'Clinical Weight Loss: Strategies and Techniques.' Explore the intersection of nutrition, exercise, behavioral psychology, and advanced clinical approaches to address obesity. Equip yourself with evidence-based practices, personalized interventions, and the multidisciplinary skills needed to guide individuals on successful weight loss journeys. Join us for a transformative learning experience in healthcare, blending science and practical application for improved patient outcomes.

This course sets out the legal and regulatory requirements for safety reporting in clinical trials of medicinal products under the jurisdictions of the European Union and the USA. It builds on the foundation laid by our companion course CT13, Safety Reporting in Clinical Trials, and provides greater detail of specific requirements in those jurisdictions.