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International - Activity
Data Management Guidelines Issued by British Medical Research Council
Volume 9, No. 4, September 2001
Basic policies on gathering, storing, and retaining research
data were issued by the Medical Research Council (MRC) in England for all
scientists supported by the MRC as part of its guidelines for good research
practice.
The complete guidelines for good research practice, published in
December 2000, can be accessed through the ORI web site by selecting
"International" in the Resources section and clicking on the MRC link.
The guidelines state that data should be stored in a way that
permits a complete retrospective audit and monitored regularly to ensure their
completeness and accuracy. Primary data should be retained for 10 years from the
completion of the project, but research records related to clinical or public
health studies should be retained for 20 years.
The basic policies that apply to notebooks and electronic
records follow:
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All raw data should be recorded and retained in indexed
laboratory notebooks with permanent binding and numbered pages or in an
electronic notebook dedicated to that purpose.
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Machine print-outs, questionnaires, chart recordings,
autoradiographs, etc., which cannot be attached to the main record should be
retained in a separate ring-binder/folder that is cross-indexed with the
main record.
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Records in notebooks should be entered as soon as possible
after the data are collected. Recorded data should be identified by date of
the record and date of collection if the two do not coincide. Subsequent
modifications or additions to records should also be clearly identified and
dated.
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Special attention should be paid to recording accurately the
use of potentially hazardous substances (e.g., radioactive materials) in
both laboratory notebooks and any central logbooks.
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In clinical studies, consent forms should be kept securely
with the raw data, and normally for the same period of time.
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Supervisors should regularly (monthly or as appropriate)
review and "sign-off" notebooks of researchers to signify that
records are complete and accurate. Queries should be discussed immediately
with the individual who recorded the data and any resultant changes to the
records should be signed by both. Authentication of data collected and
recorded electronically requires special attention.
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If the data are recorded electronically, the data should be
regularly backed up on disc; a hard copy should be made of particularly
important data; relevant software must be retained to ensure future access,
and special attention should be given to guaranteeing the security of
electronic data.
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Assurance
