GoingToMeet

This course will provide proven strategies for preparing, launching and managing a clinical study from protocol to final report.

At the conclusion of this course participants should be able to:

Describe the role of the study manager in reaching the study objectives.
Explain clinical research phases in drug development and describe basic concepts of study design.
Explain the regulatory framework in which studies are conducted and how compliance with the applicable regulations is achieved.
Identify the activities involved in study planning and start up, including feasibility and budgeting.
Qualify, select and oversee vendors and external resources for the study.
Identify various types of clinical trial communication plans.
Describe the data management and statistical evaluation process and be able to manage the final study report preparation.
Recognise European safety reporting requirements.
Describe the quality management system.
Discuss risk management and contingency planning.