NIH requirements for Data management
Dear EpiData friends,
Recently I was talking to a friend about the professionalism of research x professor-student structure in research and then he showed me a past call of NIH grant wich in part I pasted here.
I was somehow surprised, because I didnt know that all these should be in a project.
Data and Biostatistics Core: Required. Each application must include a The Data and Biostatistics Core is a resource to the multi-project application, providing for the data management and statistical support of the overall Center and individual research projects. The Data and Biostatistics Core has several components: an electronic data management system, a data management implementation plan, and biostatistics support. A full-time Data Manager must be present onsite at the Center or at the place where the electronic data management system is hosted and statistical expert(s) should be available as needed.
Applications must provide a detailed description of the existing or planned data management system. The data management system must be capable of collecting and managing data from the participating study sites in order to ensure uniformity of procedures and high quality data. The data management system should reside at the endemic area site(s) and data management staff will be responsible for the design, development and testing of databases and data management software, validation of the data system, training of data management and field personnel on data collection procedures and activities, maintenance of the database and software systems, documentation of changes, and preparation of data dictionaries and standard operating procedures for all aspects of data management. Each TMRC and related field sites should have computers, connectivity to the internet and communications capabilities. For sites without such capabilities, funding for such infrastructure should be budgeted in this core and the infrastructure should be in place before the end of the first year of the grant.
The data management system should include, but is not limited to:
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security features for controlled access to all project data;
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a tracking system for data forms, activities, and study samples;
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date and time stamping of all data records;
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audit trails to track all changes made to data records; and
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a reporting system that generates error reports and summary information reports.
If applicants do not have the capability for the data management system at the time of application submission, the applicant should describe a plan for designing and implementing a fully operational data management system based on the system requirements, including provisions for the time frame for design, development, testing, validation, and training activities. Plans and procedures must be in place to provide security against anticipated risks, including loss of confidentiality of subject electronic records and data summaries.
Each TMRC should have staff with data management (Data Manager) expertise at each site. The Center should have access to dedicated statistical expertise that informs the research study design and provides the ability to conduct statistical data analysis. They should provide for activities such as study design and protocol development and where appropriate, generating interim tables, preliminary statistical analyses for progress reports, and assisting with statistical issues related to laboratory testing and results.
Abraço forte e que a força esteja com você,
Dr. Pedro Emmanuel A. A. do Brasil Instituto de Pesquisa Clínica Evandro Chagas Fundação Oswaldo Cruz Rio de Janeiro - Brasil Av. Brasil 4365 Tel 55 21 3865-9648 email: pedro.brasil@ipec.fiocruz.br email: emmanuel.brasil@gmail.com
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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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