groups » Data Management and Statistics » Electronic Data Capture
Over time there has been a shift or campaign to shift from the paper based way of data capture to a paper less system (EDC)because of several reasons ranging from tight time lines for trials to reducing redundancy and also the need to improve on data quality. I am interested in the experience of others regarding EDC particularly on multi-centre trials done in resource poor set-ups. What are the major requirements as well as preferred software solutions which would still allow compliance to GCP guidelines?
Ray.
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Benoit Marchal
11 Feb 2013
For the requirements, you can start with the following Guidance from the FDA:
http://www.fda.gov/regulatoryinformation/guidances/ucm126402.htmWe also started a working group on LinkedIn collecting the requirements for a Tablet based EDC system with offline capacity (thus good for resource poor set-ups): https://docs.google.com/spreadsheet/ccc?key=0AqiftCiaTEiBdGFkS1dOUkpzdi1XN2pKUS1LQjdpNmc&usp=sharing
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