August 2024 SOCRA Source Journal - Journal - Page 65
TABLE 2
TABLE 2
Study
Participant
Engagement
Example
Study Participant
Engagement
Example
either in the minutes or some
other document, such as an
assumptions log. This will help
the team when reviewing what
decisions were made previously
and why they were made.
Quality Assurance
Planning impacts the quality of
a research project. The project
manager must have plans to
ensure that the project is on
target, completed in a timely
manner, and high quality (Table
6). Part of maintaining a quality
project is evaluating 昀椀nances
and resources. This includes
invoices, billing, contracts,
progress reports, and personnel.
Tasks related to evaluating
昀椀nances and resources include
determining the frequency of
budget reviews and the actions
to be taken if the project is over
the budget.
Data covers reports, missing
data, and errors. Considerations
include determining:
• How to enter the data
and ensure that they are
entered correctly
• Whether auditing will
be conducted and if so,
how often
• Whether double data entry
will be used for a certain
percentage of the data.
• For industry-sponsored
clinical trials, the sponsor
may provide a monitoring
10
plan. The project manager
must determine how to
implement the plan and
meet monitoring and
quality timelines.
“Regulatory,” covers informed
consent, serious adverse events,
and documentation. The
project manager must develop
a process to document that
informed consent was obtained.
The process must include how
to ensure access to and use
of the latest version of the
informed consent document.
Serious adverse events and
adverse events must be tracked,
documented, and 昀椀led.
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