August 2024 SOCRA Source Journal - Journal - Page 40
services for all sites. Along with
preparing the initial submission
for approval to conduct the
clinical trial, the site must also
routinely report updates to their
IRB per the IRB’s requirements.
These things include but may
not be limited to adverse events,
serious adverse events, and
protocol deviations, including
preparation of an annual renewal
submission.
Maintenance of regulatory
documentation is another
expectation of clinical research
sites. Clinical research sites
must maintain the regulatory
documents appropriately and
for the required length of time.
Data must follow ALCOA+; they
must be attributable, legible,
contemporaneous, original, and
accurate and other attributes.
This ensures that if the FDA
needs to review what happened
during the clinical trial, they can
follow the trial step by step.
While investigators are allowed to
have a 昀椀nancial interest in participating in the clinical trial, it cannot
exceed a certain threshold. All
investigators must sign a 昀椀nancial
disclosure form, indicating any
昀椀nancial interest in the test article
and for any payments that have
been received from the sponsor
for other services they may have
provided. The investigator’s
responsibilities include following
guidelines set forth by the
International Conference on
Harmonisation (ICH) Version E6
(R2) for Good Clinical Practice
(GCP).
Clinical research sites must
be trained in GCP and submit
documentation of that training.
Key points in GCP (Sections 4.1
to 4.13) are to:
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Conduct the clinical trial
in accordance with the
current protocol
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•
•
•
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•
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•
Assume responsibility for
the proper conduct of the
trial
Have adequate facilities/
number of quali昀椀ed staff
Ensure that trial staff are
quali昀椀ed, informed, and
trained
Maintain accurate, complete
records
Provide direct access to all
trial-related records
Be thoroughly familiar with
the investigational product
and be responsible for
investigational product
accountability
Report serious adverse
events immediately
Obtain IRB or IEC approval
Obtain informed consent
per ICH E6 (R2) GCP Section
4.8 prior to the subject’s
participation
Provide progress reports to
the IRB or IEC.
Investigators and sub-investigators must be identi昀椀ed Form
FDA 1572, which essentially
states that the investigator will
be responsible for the clinical
trial at their clinical research
site. The form also identi昀椀es all
locations where research services
will be conducted, including
laboratory services being used.
Also, site staff must meet 21
CFR 312.60-312.70 regulations
and be aware of patient
con昀椀dentiality and should never
send any documents containing
personal identi昀椀ers.
Whether the clinical research
site is using electronic or paper
documentation, staff must
always follow ALCOA+ and
Good Documentation Practices.
According to the FDA, “if it’s not
documented, it didn’t happen.”
The documentation should cover
who, what, when, where, and how
to paint a clear picture of what is
SOCRA SOURCE © May 2024
happening with the clinical trial for
monitors and the FDA.
Clinical research site staff must
report adverse events (AEs) and
serious adverse events (SAEs)
to the sponsor. The side effects
listed in product labeling come
from AEs and SAEs reported by
participants during clinical trials.
The AEs and SAEs can help the
sponsor determine whether to
continue the work to take the
drug to market. Table 6 provides
an overview of AEs and SAEs.
SAE reports must be submitted
within 24 hours of learning of
the SAE. The safety team at the
sponsor or the CRO will review
the SAE report immediately, as it
might impact other participants.
Safety followup is critical even
after participants take the last
dose of the study drug, for a
speci昀椀ed period of time. The drug
can still be in the participants’
systems and AEs and SAEs can
still occur. Deaths and SAEs
occurring after the 30-day safety
follow-up period AND considered
related to study treatment or
study procedures must also
be reported. If a participant or
participant’s partner becomes
pregnant while on the clinical
trial, follow up is usually done to
determine the health status of the
child.
Once all participants have
been enrolled and completed
the study, the sponsor, CRO,
and clinical research sites work
together during study close-out
to ensure that all of the data have
been entered and monitored,
and that the data are accurate
and clean. Any outstanding
documents are collected and
昀椀led in the study’s trial master
昀椀le. The sponsor or the CRO’s
monitoring team conducts a
close out visit at each site that
is active and participating in the
clinical trial, whether or not they
enrolled any participants. All