DOCS CRAcademy

€ 1050 (excl. VAT)

Netherlands

29, 30, 31 of March 2010

United Kingdom

TBD

Curriculum summary

This training presents the basic elements of Clinical Research and the regulations governing research, combined with training in the practical skills fundamental to successful clinical trial management.

The training introduces the nature and concepts of Clinical Research, the Clinical Trial process and the Regulatory framework in which clinical research is conducted.

The training emphasises the practical side of clinical trial management, demonstrating the principles involved in the accurate collection, recording and reporting of data according to Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs).

This “hands-on” approach ensures that the acquired knowledge and skills will be useful and valid in the workplace.

Lectures are informal and interactive so as to introduce individuals to the industry requirements. To emphasize the global context in which Clinical Trials are executed, the course is given in English.

Learning objectives & Benefits
After completing the course participants should be able to:
• Understand the relevance of clinical trials to the drug development process
• Prepare and conduct visits according to GCP and other requirements
• Outline the relevance of clinical trials in the drug development process
• Design a simple protocol and draft of a CRF  

 Learning objectives (continued)

• Demonstrate the basic principles of
statistical considerations in the design of a clinical trial
• Review clinical trial data and documentation, identify issues and
implement corrective action when necessary
• Summarise in outline both European and local ethical and regulatory requirements.

Programme outline

An introduction to:
• Drug development
• ICH-GCP and EU Clinical Trial directive and local drug laws
• Statistics for CRAs
• Protocol design
• Clinical trial design and theory workshop
• Case Report Form design
• Giving and receiving feedback workshop
• Pre-trial organisation
• Ethics committees and informed consent
• Investigator selection and motivation
• Source Data Verification and Clinical Trial Monitoring
• Quality Assurance
• Phase I studies
• Adverse events and Adverse drug reactions
• Regulatory Affairs / Market Authorisation Approval
• Clinical Trial Applications
• Clinical Research in Medical Devices
• Examination preparation

The learning scheme of this course is based on lectures, group work, activities and quizzes.