February 2024 SOCRA Source Journal - Journal - Page 23
the time we opened our first
phase I trial, and many of our
research staff were transitioning
back to the clinic from working
from home. What had not
returned to normal was our
monitoring visits. Our hospital
network did not allow visitors
or vendors at the time we
began enrolling subjects, and
many sponsors continued to
monitor our work remotely. The
pandemic forced us to give
up our trusted paper source
and subject binders and move
to electronic documentation.
Thankfully, our network had
invested in an eRegulatory
platform at the start of the
pandemic, and we were able to
place our regulatory documents
including protocols, consents,
1572s, delegation of authority
logs, training documentation, as
well as deviation and SAE logs
in a central, web-based location
that was accessible to research
staff as well as monitors. We
upload source documentation,
such as AE logs, central lab
requisitions, and outside
specialist notes, such as
ophthalmology exams, to our
EMR so that monitors can view
all the source they would have
reviewed in a subject binder
electronically. We are currently
working with a research-certified
analyst on our EMR team to
establish a process by which
adverse events can be routed
to investigators for causality
assessment and signature
within our EMR so that we can
further reduce our paper-based
sources. Moving to electronic
source documentation has
allowed us to maintain team
communication at a time
when our team was not
physically together and has
significantly reduced our
paper consumption. It has
also allowed us continuity in
providing sponsor access to
subject data at a time when
many sites paused enrollments
and study activations.
Building an early-phase
oncology practice is challenging
even in times of stability. When
we enrolled our first phase I
subject in the summer of 2021,
we could not have imagined
that we would activate more
than 10 early-phase trials in
the coming year. Our site has
been fortunate to have access
to technology, flexible and
collaborative research and clinic
staff, and administrators who
are dedicated to providing our
subjects with the best treatment
options.
Acknowlegement:
The author would like to thank
Adam Byers, MS for the use of
Table 1.
REFERENCES
1. Getz, K. A., Campo, R. A., & Kaitin, K. I. (2011). Variability in protocol design complexity
by phase and therapeutic area. Drug Information Journal, 45(4), 413–420. https://doi.
org/10.1177/009286151104500403
2. Fortes, B. H., Tailor, P. D., & Dalvin, L. A. (2021). Ocular toxicity of targeted anticancer agents.
Drugs, 81(7), 771–823. https://doi.org/10.1007/s40265-021-01507-z
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