Data Management for Medical Device Trials: Best Practices

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.

Data Management for Medical Device Trials: Best Practices was presented by Helen Colquhoun, MD, CEO, of Pleiad Devices and aired on 2007-11-01. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Mapping Your Case Report Forms to CDASH

This is the second in a series of three audio conferences focusing on the CDASH standard, and in this session the speaker provides practical knowledge for initiating the transition from sponsor-specific CRFs to CDASH-conforming data structures. CDASH, the CDISC data capture standards, defines CRF content for sixteen of the most commonly used data domains, and allows data to flow from the CRF smoothly into SDTM, the CDISC electronic regulatory submission standards. Each sponsor will eventually have to decide whether to adopt CDASH, and this session provides the tools to do both the impact analysis and the CRF mapping necessary to make that decision.

Mapping Your Case Report Forms to CDASH is being presented by Kit Howard, Principal and Owner, of Kestrel Consultants and airs on Tuesday, September 15, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Data Management for Medical Device Trials: Best Practices

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 will cover 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 is presented Helen Colquhoun, MD, CEO of Pleiad Devices. For more information of Data Management for Medical Device Trials: Best Practices, please visit our site www.fxconferences.com