Clinical Research Training for the Investigational Site Team

Clinical Operations Courses

Faced with a clinical study and uncertain how to deal with it? This course will take away your doubts as you get the insight in ICH-GCP, the legal aspects and the management of clinical trials. You will know how to deal with informed consents, adverse events, audits and get practical tips on protocol reading and effective patient management.

dates

location

language

950,00 €

Full description & trainer
Programme highlights
Learning objectives
Workshops & extras

Full description

This is a two-day introductory course specifically designed for clinical site personnel such as study nurses and study co-ordinators. In particular site staff of hospitals will learn how to conduct a clinical trial and how to comply with current regulations and guidelines on clinical trials. Highlights of this
course include a number of interactive workshops on how to prepare for a clinical trial, how to manage an active trial and how to motivate patients.

Who should attend?

Investigational site personnel who want to be proactive in getting quality results in their research centres. All hospital personnel involved in conducting
clinical trials. No previous knowledge of clinical research is required.

Trainers

Introduction to drug development
ICH-GCP (Good Clinical Practice)
The study protocol as opposed to regular practice
Study preparation & Managing the active study
Adverse event reporting
Study closure
Preparing for audits

To familiarise participants with current clinical research regulations and guidelines
To provide hands-on information on how to manage a clinical trial on site in practice
To provide insights on effective patient management in clinical studies

Workshops

Informed Consent
Study recruitment
Sample CRFs (Case Report Forms) & Source Data
Audit findings

Extra's

Comprehension Test

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Clinical Research Training for the Investigational Site Team

Clinical Research Training for the Investigational Site Team