Study Nurse Qualification

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Intensive course

Contents:

• Introduction to clinical trials
• Legal guidelines and regulations in clinical research (ICH/GCP)
• Responsibilities of investigators, study nurses and monitors
• Submissions, applications and registration
   (Ethics Committee & authorities)
• Study Protocol and patient information
• CRF, source data and electronic documentation
• Study medication / laboratory
• Investigator Site File
• Adverse events (AE/SAE)
• Study coordination
• Coordinating and conducting clinical trials
• Monitoring visits: recruitment, qualification & initiation

Aim:

This intensive course specifically addresses practicing healthcare professionals. It provides you with a recognized qualification in Clinical Research and all the knowledge you require to work as a Study Nurse or Study Coordinator.

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