[EpiData-list] NIH requirements for Data management

epidata-list at lists.umanitoba.ca epidata-list at lists.umanitoba.ca
Wed Oct 20 16:22:29 CDT 2010


  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.



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