Using IVR Clinical Concepts' electronic
patient diaries is an effective and efficient method
to collect data in real-time from patients during studies.
Real–time data provides you full visibility of key trial
information, which enables quicker decision-making regarding
the progress of a clinical trial.
Prior to the development and implementation of IVRCC'sElectronic Patient Diaries, the only option for
patients was to keep a daily paper diary throughout the
study; they were requested to record symptoms when they
experienced them, however, often times the sites and the
sponsors questioned when they were filled out.
Thus these paper diaries have several major drawbacks,
whereas the IVRCCElectronic Patient
Diary provides a number of advantages and efficiencies:
Paper patient diaries cannot be tracked for adherence
to the reporting schedule; if the patient forgets to
complete the diary on the date the symptom occurred,
they can complete the diary later, increasing the likelihood
that data which is entered is inaccurate.
The IVRprotocol often defines
a window of time during which the patient reports symptoms
that they are experiencing at the moment or within the
previous 12-24 hours. Reporting parameters are set depending
where on the globe the patient resides. Each patient
entry is time stamped with the patient’s local
time documenting exactly when the call was made.
The data reporting structure surrounding paper diaries
is slow, and costly; the diaries are brought in at routine
visits in intervals of weeks or months, and the onus
is placed on the investigative site to oversee compliance
and uncover anomalies in the data. By the time these
aberrations are discovered, the patient can no longer
remember the correct response and important data is
lost which can impact the outcome of the study.
IVRCC'se-PRO is programmed
to generate an alert when data is entered which is invalid
or outside accepted ranges. Respondents are immediately
prompted to re-enter data. Thus, conflicts are resolved
remotely and instantly. ”
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