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Checklist for Resuming Clinical Research
The following checklist outlines actions to consider for resuming clinical research. This
checklist is meant as guidance for assessing safety for clinical studies and sites. When
working at non-UMB clinical sites, safety procedures for the host site should be
followed. Concerns that the host site does not have adequate safety procedures in
place should be reported to the clinical site leader. Some items may not apply to every
clinical site. Check N/A, or customize this form, as needed.
CLINICAL OPERATIONS
ITEM
COMPLETE
N/A
NOTES
Develop a work schedule to minimize onsite
personnel.
Enroll approved personnel in SAFE on Campus
screening tool or create alternate screening plan
for any personnel unable to access SAFE on
Campus.
Plan to maintain physical distancing (6 feet of
separation) whenever possible and promote use
of face coverings when physical distancing
cannot be maintained.
Ensure you have sufficient Personal Protective
Equipment (PPE) supplies to conduct research
safely. Take inventory and order well in
advance.
Cross-train research staff to fill in for others who
may be sick or unable to come to work.
Train all research personnel on appropriate use
of PPE and safety precautions.
Develop a plan for cleaning and disinfection of
high-touch surfaces within the clinic and ensure
supplies are available.
Routinely back up critical research data.
Make a plan for the sudden cessation of
operations, such as in the event of COVID-19
infections of clinical staff or participants.
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CLINICAL FACILTIES
ITEM
COMPLETE
N/A
NOTES
Secure approval from EACH clinical site(s) for
resumption of research activities (e.g., UMB,
UMMS, FPI).
Waiting and clinical areas have been
reconfigured to promote physical distancing
(see EHS Guidelines).
Physical distancing signage in place.
Adequate alcohol-based (60% or more) hand
sanitizers are available.
Plexiglass or clear barriers are installed
between reception and waiting areas.
Protocols are in place for custodial service
cleaning.
Adequate IT is available for telemedicine visits.
PARTICIPANT MANAGEMENT
ITEM
N/A
NOTES
Participants advised to make appointments
online or call before arrival.
Measures are in place to limit participant
contact with computers, keyboards, or other
equipment.
Measures are in place to promote continued
use of telemedicine.
Protocols are in place to promote online or
telephone participant check-in.
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Updated screening protocols are in place for
COVID-19 symptoms.
Communication plan for informing participants
of any potential contact with suspected
COVID-19 infected person(s).
Protocols are in place for managing
participants with acute respiratory symptoms.
Protocols in place to limit the use of nebulizers.
Requirements for the use of facemasks and
other PPE are in place.
Procedures are in place to prohibit visitors,
children, or guests
Protocols are in place for transporting
participants with respiratory symptoms to home
or to the local hospital.
Communication messages have been
developed and implemented to inform
participants on scheduling appointments and
which visits should be in person or virtual.
COMMUNICATIONS
ITEM
COMPLETE
N/A
NOTES
Personnel are subscribed to receive UMB alerts.
Communication plan for informing research
personnel or other exposed persons of any
potential contact with suspected COVID-19-
infected person(s).
Communicate with all involved persons the
availability of the UMB Hotline for reporting
safety or other non-compliance concerns.
COVID-19 procedures applicable to the clinical
site have been reviewed with all members of the
team.
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List of critical contacts has been complied and
provided to all team members.
Expectations and roles have been
communicated to all personnel to avoid potential
confusion and conflicts.
Personnel have access to materials and
resources that may be needed to work from
home.
Meetings have been transitioned to remote
formats, such as Zoom, Webex, or Microsoft
Teams whenever possible.
CLINICAL SUPPLIES
ITEM
COMPLETE
N/A
NOTES
Ongoing inventory plan for clinical materials,
particularly those that are controlled, high value,
and/or high risk is in place.
As possible, a plan to maintain backup stocks of
materials (e.g., cell lines) to ensure any
disruption to operations does not result in their
loss is in place.
SECURITY
ITEM
COMPLETE
N/A
NOTES
Personnel have been provided the following
contact information:
Emergency911
UMB Police Non-Emergency and Safe
Walk/Safe Ride410-706-6882
EHS410-706-7055
UMB Hotline866-594-5220
COVID-19 hotline - 800-701-9863
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System for monitoring for life-threatening
emergencies is in place (due to fewer people in
the workplace, life-threatening emergencies may
go undetected, consider implementing a “text-
in/text-out” or similar system).
Guidance to all personnel to properly store
valuables (e.g., laptops are out of sight and in
locked drawers) has been provided.
Clinical doors will be locked at the end of each
day.
Ensure windows are closed, if applicable.
Guidance to all personnel to take needed
personal belongings home at the end of each
day has been provided.
ENERGY REDUCTION
ITEM
COMPLETE
N/A
NOTES
Any non-essential equipment will be unplugged
when not in use, even if it is turned off.
Fume hoods will be closed when not in use and
at the end of each day.
Lights will be turned off when personnel leave.
In UMB facilities, plans to avoid working 7 p.m.-7
a.m. are in place (most UMB buildings are on
energy setbacks during this time and non-
research buildings are also on energy setbacks
on weekends and holidays).
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