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?
For the requirements, you can start with the following Guidance from the FDA:
We 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