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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