Professional Training

By: Clinical Research Solutions  27-03-2011
Keywords: Consulting, Training, quality assurance

All our workshops are approximately 3 hours in length and include the following elements:
Hands-on exercises
Executive summary
Quiz to reinforce the main concepts
Certificate of training




Examples of our workshops are as follows:

Good Clinical Practice Workshop
This workshop covers the ICH-GCP regulations, with a particular focus on investigator responsibilities. It covers the following topics
A history of the main events and documents leading to ICH GCP
ICH-GCP guidelines with focus on investigator responsibilities, informed consent, source documents and adverse event reporting
Hands-on exercise dealing with informed consent

Clinical Research Operations
This workshop is an introduction to efficient clinical research operations and covers the following topics:
Standard Operating Procedures: importance, creation, implementation
Structure and roles of the research team
Tracking a study from feasibility to initiation to completion
Maintenance of study documents
Investigator initiated trials from grants to implementation
Hands-on exercise on Standard Operating Procedures

Budget Evaluation and Preparation in Clinical Research
This workshop focuses on the financial aspects of clinical research operations and covers the following topics:
General overview of costs and cost structures
Identifying budget components of a clinical research project
How to evaluate a pre-established budget, with a focus on developing and using tools
Building a budget for investigator driven projects
Maintaining finances

Currently other relevant workshops are under development. 

Keywords: clinical research, Consulting, quality assurance, Training

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