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 data management plans, CRF design, coding and data quality. Within these processes, this courses 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.
After this course, participants should be able to:
Understand key clinical data management terminology
Better interpret the evolving role of the Clinical Data Manager within the biometrics team
Have a solid understanding of data management plans, CRF design (both paper and EDC) and coding
Understand Good Documentation Practices (GDP)
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
CRAs and Monitors
09:00 – 09:30 Welcome & Registration
09:30 – 10:30 GCP Basics for Data Management
10:30 – 11:15 CRF Design: Paper vs Electronic CRF
11:15 – 11:30 Morning Coffee Break
11:30 – 12:15 CDASH Basics
12:15 – 13:00 Database Setup Tasks and Responsibilities
13:00 – 14:00 Lunch
14:00 – 14:45 Data Management Plan Development
14:45 – 15:15 Data Quality in Clinical Trials: cleaning and holistic data review
15:15 – 16:00 Coding of Clinical Terms
16:00 – 16:15 Afternoon Coffee Break
16:15 – 17:00 Data Management and Connection Risk-Based Monitoring (RBM) Strategy
17:00 – 17:30 Strategies for Good Documentation Practices (GDP)
17:30 – 18:00 Wrap-up and Q&A session
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 WCRF
CROS NT proudly supports the World Cancer Research Fund throughout 2016. In occasion of this course, CROS Academy will donate 20 EUR for every participant in honor of WCRF.
ABOUT WCRF: World Cancer Research Fund International is the world’s leading authority on the link between diet, weight, physical activity and cancer. Their vision is to live in a world where no one develops a preventable cancer. More information on www.wcrf.org