Key Objectives:

• Review the phases of clinical research and how they advance a drug to market globally
• Understand the terminology and the key tools of clinical research
• Discuss the roles of the key people involved in clinical trials
• Gain an understanding of A step by step guide to how clinical trials are set up and run globally
• Decipher the framework of clinical trial regulations in Europe Gain an Overview of the EU Clinical Trial Directive and GCP Directive and some of the key issues
• Ensure you comply with regulatory inspection 

PROGRAMME

Understanding the phases of clinical research and how they advance a drug to market globally

• How does clinical research fit into how a drug is a developed internationally?
• Gaining a clear picture of what happens at eachphase of clinical research:
• Phase I  -  Phase II   -   Phase III and Phase IV
• Where are the trials carried out, and why are particular countries used most frequently?

 Understand the terminology and the key tools of clinical research

• Key terminology will be explained including: randomised, single blind, double, blind, crossover and parallel groups, placebo and controls, GCP, CRO, SMO
• Key tools used: SOPs, protocol, CRF and investigator brochure

What are the roles of the key people involved in clinical trials?

• Group discussion on who is involved in clinical trials - the CRA/Monitor, Clinical
• Trial Administrator/Clinical Trial Assistant, Project Manager, Clinical Research Manager, Medical Director and Medical Advisor, CRO personnel, the investigator
  and other key people at the study site

A step by step guide to how clinical trials are set up and run globally including meeting the requirements of the Clinical Trial Directive and new GCP Directive

• Why GCP is so important in all countries when carrying out clinical trials
• Identifying and selecting investigators
• Informed consent/Patient Information procedures
• The importance of Ethics Committees (ECs)/ Institutional Review Boards (IRBs) 
• Study set up procedures
• The role of the investigator, pharmacy, and laboratories
• Patient recruitment – particular issues for global trials
• How are trials monitored?
• Audit and inspections
• Safety considerations and reporting
• Study drug management and accountability
• Study closure procedures
• Archiving study documentation

Special considerations for running clinical trials internationally

• Different medical practice
• Logistical considerations
• Patient recruitment issues

How is data from clinical trials managed?

• Recognising the importance of good quality data and managing data queries
• Combining data from many sites and in different countries
• Clinical trials in the future –  e-clinical trial systems including collecting data using EDC to speed up data collection

Regulatory control of international clinical trials

• The role of the regulators in controlling clinical trials  - FDA and EMEA
• ICH (International Conference Harmonisation) for clinical trials – including the CTD (Common Technical Document) – the global dossier
• The EU Clinical Trial Directive and how it has affected the way clinical trials are carried out – including how different countries have implemented the requirements