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Essentials of Clinical Study Management

Nov 5 2014 8:00AM - Nov 7 2014 3:30PM | Holiday Inn Bloomsbury Coram Street London WC1N 1HT United Kingdom

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        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.

            Learning Objectives 

              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

              Contact Information 

              Registration Questions
              Phone.: +41 61 225 51 51
              Fax: +41 61 225 51 52
              Monday-Friday 8:00-17:00 CET

              Agenda and Event Logistics
              Magdalena Lewandowska, Event Manager
              Phone: +41 61 225 51 65
              Fax: +41 61 225 51 52




              Previous Next


              Day 1 Wednesday, Nov 5, 2014

              • 8:30AM - 8:45AM (GMT Standard Time)

              • 8:45AM - 9:30AM (GMT Standard Time)

                Session 1: DRUG DEVELOPMENT
              • 9:30AM - 10:15AM (GMT Standard Time)

                Session 2: QUALITY FRAMEWORK
              • 10:15AM - 10:45AM (GMT Standard Time)

                COFFEE BREAK
              • 10:45AM - 11:45AM (GMT Standard Time)

                Session 3: REGULATORY OVERVIEW
              • 10:45AM - 11:15AM (GMT Standard Time)

                Session 7 continued: RESOURCING
              • 11:15AM - 12:45PM (GMT Standard Time)

                Session 8: STUDY PREPARATION
              • 11:45AM - 12:30PM (GMT Standard Time)

                Session 4: CLINICAL DEVELOPMENT
              • 12:30PM - 1:30PM (GMT Standard Time)

              • 1:30PM - 2:30PM (GMT Standard Time)

                Session 5: STUDY DESIGN
              • 2:00PM - 3:30PM (GMT Standard Time)

                Session 6: STUDY PLANNING
              • 3:30PM - 4:00PM (GMT Standard Time)

                COFFEE BREAK
              • 5:30PM - 6:30PM (GMT Standard Time)

                DRINKS RECEPTION

              Day 2 Thursday, Nov 6, 2014

              • 8:30AM - 10:45AM (GMT Standard Time)

                Session 7: RESOURCING
              • 10:45AM - 11:15AM (GMT Standard Time)

                COFFEE BREAK
              • 12:45PM - 1:45PM (GMT Standard Time)

              • 1:45PM - 2:45PM (GMT Standard Time)

                Session 9: IMP MANAGEMENT
              • 2:45PM - 4:15PM (GMT Standard Time)

                Session 10: STUDY COMMUNICATION
              • 3:45PM - 4:15PM (GMT Standard Time)

                COFFEE BREAK
              • 4:15PM - 5:00PM (GMT Standard Time)

                Session 10 continued: STUDY COMMUNICATION

              Day 3 Friday, Nov 7, 2014

              • 8:30AM - 10:15AM (GMT Standard Time)

                Session 11: SITE MANAGEMENT
              • 10:15AM - 10:45AM (GMT Standard Time)

                COFFEE BREAK
              • 10:45AM - 11:45AM (GMT Standard Time)

                Session 12: EVALUATION AND REPORTING
              • 11:45AM - 12:30PM (GMT Standard Time)

                Session 13: DRUG SAFETY
              • 12:30PM - 1:30PM (GMT Standard Time)

              • 1:30PM - 2:30PM (GMT Standard Time)

                Session 14: RISK MANAGEMENT
              • 2:30PM - 3:30PM (GMT Standard Time)


              Registration Fees 


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              Charitable Nonprofit/Academia Nonmember
              NonMember Government
              NonMember Standard
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