RESEARCH METHODOLOGY POSTER PRESENTATION ABSTRACTS
Please note: All posters will be displayed in
Salons 10-12.
FRIDAY, 10:15-11:00 AM
Fitzpatrick AL, DeKosky ST, Slaton J, Nahin R, Sorkin
B, Standish LJ.
Multi-site data collection and management in studies
of complementary and alternative medicine.
University of Washington fitzpal@u.washington.edu
Methodologies for collecting and managing multi-site
studies are not new to medical research. However, as more complex studies
of Complementary and Alternative Medicine (CAM) are being conducted,
investigators initiating studies across two or more clinical centers
may benefit from the experience of on-going CAM research. Two studies
sponsored by the National Center for Complementary and Alternative Medicine
(NCCAM) are currently collecting data in multi-site settings: the Ginkgo
Evaluation of Memory Study, a randomized placebo-controlled trial evaluating
Ginkgo biloba for the prevention of dementia in four US communities,
and the Trametes versicolor-Induced Immunopotentiation Study evaluating
the effect of Trametes versicolor for enhancing immune systems in vitro
and in vivo at two US universities. Issues involving data collection
include standardization of procedures, centralized training of clinical
staff, and distribution of study medication. Data management is focused
primarily on systems designed for entering data and receiving them at
a central database; successful methods have included a web-based data
entry system, scannable entry forms, and site-specific computer systems.
Reporting of Serious Adverse Events presents additional challenges as
both site IRBs and the IND holder must be notified in a timely manner.
Quality control involves audits of site-specific data and monitoring
of data by statistical analyses. In these two studies, systems across
sites and between the coordinating center and the Project Office have
been developed to meet the needs of data collection and management when
more than one center is involved. Transferring the technology and knowledge
used to manage multi-site studies may help new researchers in CAM successfully
implement their studies. This presentation will cover computer and other
applications considered most important across multiple sites.
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