August 2024 SOCRA Source Journal - Journal - Page 61
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to be assertive in obtaining
the necessary information,
and needs to be a great
communicator both with the
study team and with others
involved in the study.
Money and resources are a
luxury, especially in academia.
Appropriate planning leads
to ef昀椀cient execution of a
project. Understanding what
resources are available and
when they are available is an
important part of planning
and can help prevent delays.
For example, if the project
involves an MRI, the project
manager will need to gather
details about scheduling
and lab availability when
developing a plan. If the
research team starts enrolling
participants and tries to
schedule the MRIs without
knowing when the test is
available, they will run the
risk of project delays and the
potential of the participant
withdrawing from the study.
The project manager must
make participating in the
study as smooth as possible
for the participants and
for the research team. This
requires advance planning
with the lab, recruiters, and
昀椀nance team members.
As described above, there
are many complexities when
planning a project. A project
manager should work through
as many of those complexities
as possible, but, the planning
must transition into execution in
order to stay on schedule. There
will be times when a project
will need to start before the
entire plan has been completed.
Project managers cannot allow
themselves to get so mired in
the details that they critically
delay the start of a project.
This is a balance because at
the same time, the project
manager should not succumb to
pressure, which is common, to
start a project before adequate
planning has been completed.
The key is to balance the
amount of detail needed in
the plan along with the critical
(albeit reasonable) timelines,
milestones, and deliverables.
So, in order to plan effectively,
there are some key areas to
cover.
Some Key Components to
Include when Planning a
Project:
• Research study charter
• Operations
o Organization and File
Management
o Budget
o Study participant
engagement
o Quality assurance
• Communications
o RACI chart (Reasonable/
Accountable/Consulted/
Informed)
o Stakeholder register
Research Study Charter
A research study charter is a
brief statement describing
the study (see Table 1 on next
page). The charter serves as a
roadmap for the research team
and for those who need a quick
overview. The project manager
can share the study charter with
team members or stakeholders
who need a high-level overview
of the study.
Key things to think about when
writing a study charter:
• The research study charter
should be written in layman’s
terms as it may be used to
communicate with people who
are not part of the research
team. Sometimes it is helpful to
have an appendix of common
abbreviations and/or terms
used within the document.
• The project timeline with
details such as the start and
end dates as well as the
enrollment timeline should be
included. Timelines should be
easily accessible to the project
manager and the research
team and stored in one place.
Everyone must be able to
see their assigned tasks and
deadlines.
• Enrollment numbers and
eligibility are additional details
to include as part of the
research study charter.
• The research study charter
includes project deliverables,
milestones, and key performance indicators.
o Key performance indicators
show whether a project is
successful. For a research
project, meeting the
enrollment goals in the
designated time period is a
key performance indicator.
o Milestones might be
completing a certain report
every quarter or completing
enrollment or data collection
by a certain date.
o Milestones and deliverables
related to recruitment are
part of study participant
engagement.
o Diversity goals, such
as recruiting a certain
percentage of diverse
participants, and speci昀椀cs
should also be included.
This should be tracked to
SOCRA SOURCE © May 2024
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