Dear all
Pedro Emmanuel A. A. do Brasil gave a lengthy description of requirements for data management in studies supported with a particular funding agency (NIH). Thank you for pointing this out.
Allow me to supplement with further (lengthty) comments.
But - I should say that most EpiData users can rest assured, that EpiData software will comply with these regulations in an orderly manner - and you do not have to study details on this matter.
By orderly I mean a way which can be handled by the individual researcher, provided they set up systems accordingly. Without loosing the simplicity principles. This will be the focus for development in the first half of next year. And obviously also a focus point for developing documentation and field guides.
The good news is therefore in short: We are prepared for this challenge and have been supported financially to be able to meet these requirements. Among other donators for the GCP development (Good Clinical Practice) was a grant from Médecins Sans Frontières (research dept. in Paris) from IUATLD, who is obviously interested in getting GCP compliance when developing medications for abundant diseases in low-income countries and other field epidemiology activities, such as the Association of Public Health Epidemiologists in Ontario - Canada. Please see the funding bodies mentioned on http://www.epidata.dk/funding.htm. It is a prime privilege for me to assist in securing that EpiData Software will be able (expectedly) to handle these regulations in view of the many development areas, where this will be important in the coming years.
In summary the demands were given as: - security features for controlled access to all project data; - a tracking system for data forms, activities, and study samples; - date and time stamping of all data records; - audit trails to track all changes made to data records; - a reporting system that generates error reports and summary information reports.
These headlines are EXACTLY the reasoning behind the current re-writing of EpiData Software. I have explained about these demands previously on this list and I have participated in a European Union supported non-commercial network called ECRIN (See http://www.ecrin.org). So far we have published two reports, more are coming:
A summary of the demands stated as minimal and "maximal" implementation is contained in: Ohmann C (chair) and the Transnational Working Group on Data Management: GCP-compliant data management in multinational clinical trials. ECRIN-2, Deliverable D10, Version 1, 15 September 2008. Download from: http://www.ecrin.org/index.php?id=274
The variability has been documented in a recent publication: Wolfgang Kuchinke et al. Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres. /Trials/ 2010, *11*:80 (22 July 2010)- full text at: http://www.trialsjournal.com/content/pdf/1745-6215-11-79.pdf
My worry is that if we are not meeting the demands the whole area will become highly commercialised and out of control of the individual researcher.
(excuses for the length)
regards
Jens Lauritsen EpiData Association ps. The pile of papers I have been studying to plan this particular part of the re-writing of software is about half a meter if put into one pile.