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Purpose
of the Training Session
- Our group, Quality of Life Research
Associates, has found that a combined training session
allows all members of the research team to have a full understanding
of the nature of quality of life (QL) as an endpoint, why it was
chosen, and the background for understanding the unique measurement
considerations with QL instruments. Our experience with major
pharmaceutical companies, conducting trials for new oncologic
agents, has shown that a combined training session for the PI's,
field monitors, and data managers at the Investigators' Initiation
Meeting is the best plan. A combined session allows the team members
at each site to support each other when questions arise and a
field monitor cannot be reached. Most importantly, it allows time
to discuss pertinent questions related to QL as an endpoint and
the chosen QL measure that may interfere with protocol completion
if not resolved.
- We have found that a formal training
session not only enforces the importance of the use of
QL as an endpoint, but also "trains" everyone in the fundamentals
of administration of this brief QL instrument and the overall
process that was used to test the instrument to know that it is
reliable and valid. Unfortunately, our experience has shown that
when a formal training session has not been conducted, there have
been problems of missing data that can cause the need for controversial
imputation of data or completion errors that may cause questionable
inclusion.
- There are needed qualifications
for a trainer and certain content that is necessary for a training
session. Some pharmaceutical companies have elected to
train their own trainer after the initial training session by
our group; others have continued to use our service after the
initial trial.
- At the point when you are ready to begin
training for the LCSS, one of our group,
Dr. Patricia Hollen, would be glad to discuss the training
with you (see contact source).
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