The success of a clinical study is very much dependant on its efficient preparation and effective conduct. Study managers should be knowledgeable about required quality and regulatory standards, roles and responsibilities of team members, and be able to select and oversee internal and external resources. Study managers also should be able to anticipate potential problems, offer creative solutions and develop strategies to mitigate risk.
This training course provides a comprehensive overview of the essential elements of study management and the clinical study environment in the context of the overall drug development process. After successful completion of the training course, participants will be able to plan, execute and manage a clinical study from protocol to final report.
What You Will Learn
Featured topics include:
- Drug Development Process
- Feasibility Assessment
- Study Planning Tools
- Regulatory Framework
- Quality Management System
- Essentials of Site Management
- Resource Management
- Investigational Product Handling
- Risk Management
- Safety Reporting
- Study Evaluation and Reporting
Who Should Attend
This course will particularly benefit those newly appointed to, or interacting with, a clinical study management position, e.g. clinical research professionals with some basic experience in the field of clinical research, who need a broader understanding of the principles of clinical study management. This course will also benefit study managers in an academic research setting who interface with industry.
Level: Junior/Intermediate Level Clinical Research Professionals.
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