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Obviously it will be easier to assemble these materials if careful documentation is prepared along the
way. As a minimum every document should bear a date and a notation of authorship. Documents
retained in a word processing file should if possible contain a notation of where the document file
resides, so that it can be located for later revision or adaptation in creating related documents.
1.4.9 Poke around
The amount of activity and detail in a large project can easily exceed what the (usually
limited) staff (and time-urgent investigators) are able to handle comfortably. Despite the highest
motivation and experience, communication will be incomplete and important items will be
overlooked. Investigators should review data forms regularly to familiarize themselves with the data
in its raw form and verify that data collection and coding are being carried out as stipulated. It may
also be worthwhile even to poke around occasionally in file drawers, stacks of forms, and among
computer files.
1.4.10 Repeat data analyses
The fact that debugging is a major component of commercial software development
suggests that investigators need to make provisions to detect and correct programming errors or at
least to minimize their impact. One strategy is to have a different programmer replicate analyses
prior to publication. Typically only a small portion of analyses that have been carried out end up in
a publication, so this strategy is more economical than many others, though of course if serious
errors misled the direction of the analysis much work will have been lost. Replication begins as
close as possible to raw data offers the greatest protection, but more often other methods are used
to ensure the correctness of the creation of the first analysis dataset. An object lesson about the
importance of verifying the accuracy of data analyses is offered by the following excerpt from a
letter to the New England Journal of Medicine (Jan 14, 1999, p148):
"In the February 5 issue, we reported the results of a study … We regretfully report that we
have discovered an error in computer programming and that our previous results are incorrect.
… After the error was corrected, a new analysis showed no significant increase …"
It is a good bet that error reports such as these are the tip of the iceberg.
2. Data conversion
Picture stacks of questionnaires, stacks of medical record abstract forms, lists of laboratory
results, photocopies of examination results, and the like. Before they can be analyzed, these original
data need to be coded for computerization (even if the volume is small enough and the intended
analyses are simple enough for manual tabulation, coding is still required). This process can be a
major and arduous undertaking, and may involve the following steps for each data "stream":
1. Preparation of a coding manual stating the codes to be used for each data item and the
decisions to be made in every possible situation that occurs (see sample coding manual);
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www.sph.unc.edu/EPID168/ © Victor J. Schoenbach 16. Data management and data analysis - 531
rev. 9/27/1999, 10/22/1999, 10/28/1999