Maintaining control over your data when outsourcing is part of your company strategy can be complicated for any clinical trial Sponsor. ICH GCP E6(R2) underlines the importance of risk
assessment in your clinical trial strategy but how can you be certain that you are utilizing this effectively to manage your data, when you don’t have full control of that data? Clinical Trial Management is often conducted by individuals without extensive expertise in clinical data, and by multiple vendors with differing processes and practices. Therefore, it is even more important now for the entire clinical study team to understand the oversight required in the overall biometrics picture. Managing oversight activities needs a solid understanding of your own organizations expectations and a confident awareness of the fundamental biometrics documents and processes. A methodological approach and investigative nature also helps uncover the reality behind reports and information. This course aims to promote an understanding of the practical application of ICH GCP E6(R2) in managing the oversight of biometrics activities. We will review the requirements of ICH GCP E6(R2), look at the main documents used to document and define biometrics activities in order to understand whether that document meets both the requirements of your organization and the regulation, conduct a facilitated discussion to support you in the process of identifying, mitigating and monitoring risks associated with biometrics activities, and look at some specific techniques and tools that help reduce the burden of monitoring your data.
FOR WHOM IS THIS COURSE DESIGNED?
Any personnel with vendor oversight accountability or responsibility:
– Heads of Clinical Operations, Development or R&D
– Clinical Trial Directors or Managers
– Medical Directors and Medical Affairs professionals
– Heads of Biometrics
– Data Managers
09:00 – 09:30 Welcome & Registration
09:30 – 10:00 GCP E6(R2) requirements
10:00 – 11:00 Reviewing key biometrics documents: CRF, DMP, SAP, Output shells
11:00 – 11:30 Morning Coffee Break
11:30 – 11:45 The principals of risk assessment as a vendor oversight method
11:45 – 13:00 Identifying Biometrics risks (Round table exercise)
13:00 – 14:00 Lunch
14:00 – 15:15 Monitoring and mitigating Biometrics risks (Round table exercise)
15:15 – 15:45 Afternoon Coffee Break
15:45 – 16:15 Methods of Oversight: Risk Based Metrics
16:15 – 16:45 Methods of Oversight: Centralized Statistical Intelligence
16:45 – 17:00 Wrap up and Q&A session
Presentation, documents study, round table exercise.
After this course, participants should be able to:
- Understand key oversight requirements of ICH GCP E6(R2) and how they relate to biometrics functions
- Better interpret the primary biometrics documents used by vendors to document the conduct of a clinical trial
- Be able to assess and interpret the risks inherent in biometrics activities for a clinical trial and other analysis
- Be able to identify appropriate methods of monitoring and mitigating those risks
- Have an insight in to some specific techniques aimed to facilitate oversight of your data in a clinical trial
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.
Lisa Comarella – Director Biostatistics – CROS NT
Lisa graduated from the University of Padova in Italy with a degree in statistical science in 1999. She started her career in CROS NT in 2000 as a Statistician and Data Manager. In 2003 she became the Director of Biostatistics. She is a member of the European Statistical Forum (ESF) scientific board and she is part of the BIAS managing committee. In her career she has authored various publications and scientific articles and she has been a speaker at industry conferences and trainings related to statistics in the field of clinical trials.