August 2024 SOCRA Source Journal - Journal - Page 64
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Personnel documents,
including private documents
about individuals on the
research team, should be
stored on a secure Teams
site or channel separate from
the research study 昀椀les. This
should only be accessible
to those who should have
access. However, 昀椀les related
to personnel that should be
stored in research study 昀椀les
and accessible to all, would
be documents such as job
descriptions, organizational
charts, interview questions,
and onboarding activities.
The Indiana Clinical and
Translational Sciences
Institute often hires hourly
employees, therefore having
easy access to sample
job descriptions helps to
expedite the hiring process.
Clinical research sites
prepare internal reports such
as meeting minutes and
schedules, and more formal
reports for funding agencies
or sponsors. Reports and
project plans should be
stored in the Microsoft Teams
site accessible to the research
team. Templates and 昀椀ling
structure are necessary for
reports and project plans and
can assist with consistency
across projects.
A Gantt chart can be used
to create a study timeline.
There are several templates
that can be downloaded
from Excel and then stored in
the Microsoft Teams site for
the team to access regularly.
When using a template,
after dates are entered, the
Gantt chart will automatically
color the weeks and show
the percentage of project
completion. The Gantt chart
should be customized to the
needs of the project such
as adding columns for task
owners, costs, and contact
information. This will help
to better track information
across the various tasks when
taking a quick glance at the
chart.
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Process 昀氀ow maps help the
project manager identify steps
that may not be necessary
and if eliminated could result
in improved ef昀椀ciencies.
For example, there are
many steps in recruiting
subjects. Having a process
昀氀ow map helps the project
manager quickly identify
the recruitment structure
and more easily identify
roadblocks. When roadblocks are identi昀椀ed, 昀椀nding
solutions becomes easier with
a process 昀氀ow map. Using
the recruitment process 昀氀ow
map to review recruiting for a
speci昀椀c study is a nice teambuilding exercise to engage
everyone on the team during
the planning stage. While the
research team has reviewed
the protocol, a process 昀氀ow
map provides a different
perspective, showing the
昀氀ow of tasks and who the
responsible person is for
each task.
Budget
A budget in most cases has been
developed prior to the planning
stages of a research project and
at a very high level. That budget
should be included as part of the
study charter. During planning,
it is important to review key
budget elements such as
personnel, services such as MRIs,
and payments to participants.
SOCRA SOURCE © May 2024
The entire budget does not
need to be part of the charter
as the project manager and the
research team can refer back
to the approved budget when
necessary. Reference documents
related to the project, and
numbers related to the research
account, IRB, and ClinicalTrials.
gov, should also be part of
the research study charter
as appendices. The project
manager may manage budgets,
contracts, and memorandums
of understanding, or work with
other team members who
provide assistance with or
are responsible for managing
昀椀nance and contractual items.
It is important for the project
managers to understand their
role in managing budgets,
contracts, and memorandums
of understanding. When other
staff are responsible, the project
manager must have access to
the most recently approved
documents for each study.
Study Participant
Engagement, Recruitment,
Retention
A template for study participant
engagement, which covers
participant recruitment and
enrollment, can also be used
(see Table 2 on next page).
Study participant engagement
includes a description of the
participants and the way in
which they will be reimbursed
and paid for their participation
(e.g., check or gift card).
This should also include any
outreach plans, marketing
materials, and tracking of
barriers participants and the
study team face when engaging
in the research. Additionally,
challenges and assumptions
along with decisions based
on them should be tracked