| One of the most important resources a clinical
trial can provide is immediate access to a physician intimately
familar with both the disease being studied and the clinical
trial protocol. As part of the toll-free DCRI Clinical Helpline,
a Duke University physician is available 24 hours a day, 7
days a week via pager to assist study sites with both protocol
issues and questions about the acute care of the patients
enrolled in the trial.
Having central, rapid access to a physician with expertise
in both the disease under investigation and the clinical trial
protocol enhances recruitment, increases protocol compliance,
and significantly reduces the incidence of unblinding. The
Helpline enables the early identification of trends in adverse
events, allowing significant and clinically important protocol
amendments.
The central Clinical Helpline also allows the recording and
distribution of frequently asked questions (FAQs) and answers
to all study personnel. The DCRI Clinical Helpline has been
in operation since 1990 and has managed clinical questions
from both short- and long-term trials from more than 20 countries.
With more than 15,000 questions answered and counting, the
Helpline is a proven and invaluable resource to any clinical
research project.
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