August 2024 SOCRA Source Journal - Journal - Page 22
however, the solutions chosen
must be the right 昀椀t to solve the
pain that the research team is
experiencing.
Table 3 highlights a rubric
that can be used to assess
technology solutions and
determine whether they are
helpful. Data must have a single
source of truth. It is challenging
when data and information
related to day-to-day clinical
research, such as the study
data, who is working on each
study, the calendar, and contact
details for the clinical research
associate, are in different places
and it is not apparent where
to go to answer a question.
Solutions should consolidate
the data in a single source of
truth and reduce the time and
effort needed to track down
information.
Data must be discoverable. For
example, if the list of members
of the research team for a
study or the clinical research
associate’s contact details
are buried, and it takes a few
minutes to 昀椀nd this information,
or the data are only available
on the lead study coordinator’s
computer, this does not help
the research team.
Research team collaboration
and risk management are
necessary. If the lead study
coordinator gives notice about
leaving the clinical research site,
there will be a scramble to try
to move data from their head
or personal notepad to the site.
Solutions should always share
data across the research team
to make it easier for onboarding
and when someone does leave
the site.
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TABLE 3
Rubric to Assess Solutions
•
•
•
•
•
Data has a single source of truth
Data is discoverable
Team collaboration and risk management are necessary
Opportunities to integrate site technology with pharmaceutical
companies may be available
Investment is required
Clinical research sites work with
pharmaceutical companies
and CROs. There may be
opportunities to integrate
technology, such as sharing
data back and forth. The
research team and the clinical
research site must both invest in
technology solutions.
Two Examples of
Technology Solutions
The following examples illustrate
how to assess technology
solutions and improve study
organization and the feasibility
questionnaire work昀氀ow. Data
has a single source of truth.
Many clinical research sites
use a whiteboard to list active
studies and which members of
the research team are working
on each study. Whiteboards
are great, however, staff cannot
access them when they are at
home or not in the of昀椀ce where
the whiteboard is located. Some
sites use Excel 昀椀les and others
use bookmarks in their browser.
A great deal of data is captured
and lost in email inboxes. Data
are also stored on sticky notes,
昀椀le systems such as Google
Drive or Microsoft SharePoint,
or handwritten notes in
notebooks.
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There are many places where
data can live and many data
silos. This makes it challenging
to answer even simple
questions. Where data live
might be different depending
on each study coordinator’s
preferences.
Under current practices at
clinical research sites, data do
not have a single source of
truth. In a new world, data can
be brought together to create
a single source of truth. Study
organization is key. Clinical
research site staff have been
trying to organize their studies,
using different tools.
In the 昀椀rst example, data lives
in many places, including
browsers, spreadsheets, and
the clinical trial management
system. The 昀椀rst step would
be to organize everything
around the study. Shortcuts
and bookmarks should be used
to access the various systems
involved in the study, whether
the systems are from the
pharmaceutical company or the
clinical research site’s internal
systems. This should all be
stored in a single place. Also, it
is important to easily know the
key contacts associated with
the study.