Download Operational Assessment Checklist

CLINICAL RESEARCH IMPLEMENTATION COMMITTEE – OPERATIONAL ASSESSMENT CHECKLIST
Purpose: the purpose of this checklist is to help facilitate the committee’s goal of reviewing logistics of each
potential trial early in the activation process, to help identify potential challenges and mitigate them prior to trial
activation at UVA.
Section 1.0: General Study Questions
Title:
PI:
Study Coordinator:
Study Team:
Phase of Study
☐Pilot ☐Phase I ☐ Phase I/II ☐ Phase III ☐Phase IV
Number of patients expected
to enroll over study duration?
☐1-4
☐ 5-10
☐10-15
☐15+
Section 2.0: Investigational Product Information & Pharmacy Logistics
Are the investigational agent(s) involved
in this study FDA-approved?
How will the drug(s) be provided?
How would you describe the ‘type’ of
drug product in this study?
Any special equipment necessary? This
could include compounding equipment,
administration equipment such as
tubing/pumps, or special fluids.
☐Yes
☐No
☐By the sponsor
☐Commercially available – IDS to purchase on sponsor’s behalf
☐Commercially available – patient’s insurance to pay
Please select all that apply:
☐Oral Drug
☐Infused drug – if infused, please select:
☐ Chemo ☐ Non-hazardous (ex: most monoclonal antibodies)
☐Vaccine – If vaccine, is this considered gene therapy*?
☐Yes ☐No
*if genetic material is involved, will require biosafety plan
☐Yes* ☐No ☐Don’t Know – need pharmacy manual
*If Yes, will the sponsor be providing?
☐ Yes
☐No
Comments: ______________________________________________
Is there a pharmacy manual?
How will the drug(s)
be administered?
☐Yes* ☐ No
*If yes, please send to IDS pharmacy
Section 3.0: Drug Administration Logistics
☐IV infusion ☐ID/SC/IM injection
Please select all that apply.
☐oral
☐other (topical, intranasal, etc.)
Comments:_______________________________________________________________
Does the protocol
require frequent
monitoring during or
after administration?
☐Yes (This may be every 15 minute vitals, ECG, etc)
☐No
Are there research
blood samples
required?
☐Yes*
☐ No
*If yes, how often?(please select as many as applicable)
☐1-2 hours post infusion ☐2-4 hours post infusion ☐4-12 hours post infusion
☐Outside normal business hours (8:15am – 4:30pm)?
Comments:_______________________________________________________________
Comments:_______________________________________________________________
Version date: 10/1/2014
1
Are there restrictions
to the days of the
week patient can be
treated in infusion?
Does the protocol
require patient
isolation?
☐Yes*
Do you anticipate
needing to administer
drug or monitor
patient outside of
normal business hours
(8:15am – 4:30pm)?
☐Yes*
☐ No
*If yes, please describe: _____________________________________________________
☐Yes*
☐ No
*If yes, please describe: _____________________________________________________
☐ No
*If yes, please describe: _____________________________________________________
Section 4.0: Lab Logistics & Collection Requirements
Are there biopsies
☐Yes
☐ No
required?
Do you anticipate
☐Yes
☐ No
using the BTRF?
Do you anticipate
☐Yes
☐ No
after-hours
processing?
Are there same-day
☐Yes
☐ No
shipments or batch
shipments required?
Is there a lab manual
☐Yes
☐ No
available?
Additional Comments:
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
FINAL REVIEW OUTCOME (to be completed by the CRIC upon review of completed checklist):
Where will the drug(s) be
Please select all that apply:
administered?
☐Infusion Center ☐Clinic ☐CRU
☐Inpatient ☐Home – self administered
Will a treatment plan need
to be built for this study?
What is the estimated
timeline to trial activation?
☐Yes
☐ No
Based on acuity and checklist assessment, this trial will take approximately ____
weeks to open.
Comments:____________________________________________________
Action Items and Additional Comments:
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
Version date: 10/1/2014
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