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Fundamentals of Clinical Data Management

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EDEN AU LAC Zurich

Utoquai 45

8008 Zurich

Switzerland

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INTRODUCTION

Implementing a clinical data strategy can be complicated for any clinical trial Sponsor. The truth is there is no “manual” in place which describes how to prepare a clinical data strategy. Clinical data management plays a fundamental role in any company’s biometrics strategy. Data Managers were once associated with “Data Entry Clerk”, and the role usually required no formal training and had no defined role within clinical research. Thanks to regulatory guidelines such as Good Clinical Practice (GCP), regulatory authorities such as EMA and audits and inspections, the role of the Data Manager has changed.

The Data Manager now has more of a stake in the requirements for data collection, data accuracy and quality. Therefore, it is now important for the entire clinical study team to understand data management processes and the role of data management in the overall biometrics picture.

This course aims to cover the fundamentals of data management processes in the GCP environment such as CRF design, Data Management Plan, coding and data quality. Within these processes, this course stresses the importance of data standards such as CDASH and covers the basics of implementing these standards during database build.

The course will also touch upon the connection between data management and Risk-Based Monitoring strategy.


COURSE OBJECTIVES

After this course, participants should be able to:

  • Understand key clinical data management terminology

  • Have a solid understanding of data management plans, CRF design (both paper and EDC), data quality and coding principles

  • Comprehend the role of clinical data management in Risk-Based Monitoring


For whom is this course designed?

  • Heads of Clinical Operations, Development or R&D with limited or no data management knowledge

  • Medical Directors and Medical Affairs professionals with limited data management knowledge

  • Heads of Biometrics with limited or no data management knowledge

  • Data Managers

  • Biostatisticians

  • Medical Writers

  • CRAs and Monitors


AGENDA

09:00 – 09:30 Welcome & Registration

09:30 – 10:00 GCP Basics for Data Management

10:00 – 11:15 CRF Design: Paper vs Electronic CRF

11:15 – 11:30 Morning Coffee Break

11:30 – 12:15 CDASH Basics

12:15 – 13:15 Database Setup Tasks and Responsibilities

13:15 – 14:00 Lunch

14:00 – 15:15 Data Management Plan Development

15:15 – 15:45 Data Quality in Clinical Trials: cleaning and holistic data review

15:45 – 16:00 Afternoon Coffee Break

16:00 – 16:45 Coding of Clinical Terms

16:45 – 17:30 Data Management and Connection Risk-Based Monitoring (RBM) Strategy

17:30 – 18:00 Wrap-up and Q&A session

ABOUT THE INSTRUCTOR

Monica Pimazzoni, Director Clinical Data Management, CROS NT

Monica joined CROS NT in 2010 as the Head of Clinical Data Management after more than 20 years in the data management department of GlaxoSmithKline. In 2012, Monica became the Head of Database Programming as well and is accountable for managing workload and headcount as well as ensuring clean, accurate and complete clinical data in accordance with the project plan and ICH/GCP guidelines. Monica began her career in data management in 1987 as a data monitor in the data monitoring unit of GlaxoSmithKline. She later became a Data Manager and then a Senior Data Scientist for Clinical Pharmacology Statistics and Data Sciences. In 2007, Monica became Therapeutic Program Manager for Clinical Pharmacology Data Sciences leading data management activities across a compound/disease area through all stages of development. In her experience, Monica has a broad understanding and in depth knowledge of the clinical development and data management process. She has been involved in hundreds of studies across her career, covering Phases I-IV and observational studies and numerous therapeutic areas. In CROS NT alone, she has done extensive work in Neurosciences, Respiratory and Oncology. Her study experience has also included numerous EDC studies and she is well experienced in the implementation and database setup for EDC as well as hybrid EDC/paper studies.


CROS Academy for WINGS FOR LIFE

CROS NT proudly supports Wings For Life Fundthroughout 2017. In occasion of this course, CROS Academy will donate 20 EUR for every participant in honor of Wings For Life.

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EDEN AU LAC Zurich

Utoquai 45

8008 Zurich

Switzerland

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