[EpiData-list] NIH requirements for Data management

epidata-list at lists.umanitoba.ca epidata-list at lists.umanitoba.ca
Wed Oct 20 14:16:45 CDT 2010


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:

•

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; and

•

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 at ipec.fiocruz.br
email: emmanuel.brasil at gmail.com

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