There are no regulations in the USA or EU that specifically govern case report form development or data management practices. There are some guidelines produced by professional bodies of data managers. This presentation covers the range of data management tasks from CRF design to data entry to raising and resolving queries to tracking all aspects of data management.
There will be a short discussion of importation of data as well as safety management as it pertains to data management. Throughout the presentation, general guidance on best practice will be given.
This audio conference covers:
- All the tasks in a medical device trial that fall under the remit of data management
- The best way to complete these tasks
- What systems and procedures should be in place to ensure compliance with existing regulatory guidance
- Consequences of not following best practice
About the speaker:
Helen Colquhoun, MD holds degrees in Genetics and Medicine from the University of Edinburgh and spent several years practising clinical medicine before entering the life science industry in 1988. Initially working in the UK in the pharmaceutical industry, Helen set up as an independent consultant in 1995. Since that time she has spent increasingly more time working with medical device and drug delivery companies. In 2000 she co-founded the Pleiad group of companies and is currently CEO of Pleiad Devices, a clinical research organization based in the USA and Europe that specializes in clinical research and regulatory support for medical device companies. Helen runs Pleiad's North American operation and is based in Cambridge, Massachusetts.
Who should attend?
- Data Managers
- Clinical Project Managers
- Quality and Regulatory Managers
- Operational Management Team Members
This audio conference is classified as General Interest.