UMH ANCILLARY COMMITTEE STUDY FEASIBILTY CHECKLIST
UMH RESEARCH REVIEW COMMITTEE is NOT an IRB; all proposals must receive IRB approval before implementation.
PART ONE: For completion by study team.
STUDY DETAILS
Full Title of Study: ______
Principal Investigator
Full Name/Degrees: ______
PI Telephone: ______PI Email: ______
Name of study coordinator (s): ______
Telephone: ______Email: ______
Study Type: ____BIOLOGIC _____DRUG _____DEVICE
____CHART REVIEW _____OBSERVATIONAL _____CLINIC VISITS
____OTHER (Please explain)
Name (s) of Drugs or Devices being investigated: ______
Funding Source: ______Sponsored _____Grant Agency/Government _____PI Initiated
______Other _____N/A
Sponsor Name: ______
Are these products FDA approved? Yes NO N/A
*If yes, attach all necessary documentation *If no, provide detail information on investigational use
Is it an IND/IDE? Yes No ______Device Number
*If yes, please provide the following IND/IDE information: ______Copy of FDA Letter
______Investigator’s Brochure/Product Labeling ______Sponsor Reimbursement Package
Who will purchase the investigational drug/device/agent? ______Sponsor _____Manufacturer
______Vendor _____Other
PART TWO: To be completed at Ancillary Committee Meeting
DATE OF MEETING: TIME OF MEETING:ATTENDEES:
If you have no experience with the sponsor, have you
checked the sponsor’s reputation with colleagues? ____Yes ____No ____N/A ___Do Not Know
If you have prior experience with the sponsor, has that
experience been satisfactory? ____Yes ____No _____N/A ___ Do Not Know
Will PI need to recruit patients from external sources?
If so, will sponsor provide funding? ____Yes ____No ____N/A ____Do Not Know
Is the proposed enrollment goal realistic? ____Yes ____No ____N/A ____Do Not Know
Will enrollment compete with other studies seeking
the same patients at UMH? ____Yes ____No ____N/A ____Do Not Know
Can UMH supply all services (e.g. lab, radiology,
pharmacy) to meet the protocol requirements? ____Yes ___No ____N/A ____Do Not Know
Are inclusion/exclusion criteria overly restrictive?
(Consider the likely screen failure ratio and the number
of screen failures for which the sponsor will pay.) ____Yes ___No ____N/A ____Do Not Know
Are vulnerable populations involved, e.g. impaired
adults with special consent issues? ____Yes ____No ___N/A ____Do Not Know
Are patient compliance problems likely? ____Yes ____No ___N/A ____Do Not Know
Will the subjects benefit from participating in the study? ____Yes ____No ___N/A ____Do Not Know
Do you expect a significant number of adverse events?
(Consider the health status of the study population) ____Yes ____No ___N/A ____Do Not Know
Will patients with Medicare be enrolled in the study? ____Yes ____No ___N/A ____Do Not Know
Is this a Medicare-qualified study? ____ Yes ____No ___N/A ____Do Not Know
UMH CLINICAL RESOURCE REQUIRED
Check additional resources needed for study:
· Pharmacy storage (temperature /other
constraints) ____Yes ____No _____N/A ____Do Not Know
· Pharmacy Storage (room temperature) ____Yes ____No _____N/A ____Do Not Know
· Supplies (kits, disposables, etc.) ____Yes ____No _____N/A ____Do Not Know
· Additional Nursing Time (beyond
standard of care) ____Yes ____No _____N/A ____Do Not Know
· Additional Tech Time ____Yes ____No _____N/A ____Do Not Know
· Other Procedures ____Yes ____No _____N/A ____Do Not Know
Patient care areas being utilized for study: ____Outpatient Clinic _____Special Population ____Inpatient Unit
____Other (Cardiac Unit, OR (Main/Ambulatory/Both), Nuclear
Will the study need to recruit in the Emergency Department and/or Behavioral Unit? Yes No
How many patients will be enrolled in this study? ______Inpatient ______Outpatient
Will coordination with other clinical units/hospitals
/non-hospital services be required for study visits or procedures? ____Yes ____No _____N/A
Indicate time of day when service will be provided /
collected for all activities occurring at UMH: DAY EVENING NIGHT N/A
· Recruiting ------
· Enrollment/Consent ------
· Blood Draw ------
· Labs ------
· Treatment ------
· Drug dispensing ------
· Drug administration ------
· Pathology service ------
· Follow-up ------
· Other (please specify)
Duties research coordinator will be performing at UMH: ______
Name of person providing in-service training, if needed: ______
Describe in-service training for all involved areas at UMH, if needed: ______
Expected Length of Stay (LOS): ______
Will study result in any increase, in LOS? Yes NO
Is adequate hospital space available? ____Yes ______No ______N/A
Is the workload manageable?
(Consider staff’s current workload) _____Yes ______No ______N/A
What is the dosing schedule? _____Yes ______No ______N/A
Can UMH staff meet the dosing
schedule requirements? _____Yes ______No ______N/A
Will the study require out of hours
work for enrollment? _____Yes ______No ______N/A
Are additional specialists needed? _____Yes ______No ______N/A
Are study visits complex, presenting
possible scheduling difficulties, e.g.,
how many different study staff will
subjects encounter in a given visit? _____Yes ______No ______N/A
BUDGETS (FINANCIAL VIABILITY)
UMH Facility Fee: _____$3500.00 (one-time)
Does the budget include costs for administrative start-up? ____Yes _____No ____N/A
Will external funding cover all direct costs incurred at UMH? ____Yes _____No ____N/A
Will the sponsor’s preliminary budget cover all study-related costs? ____Yes _____No ____N/A
Will the sponsor pay for recruitment expenses? ____Yes ____No ____N/A
Are there standard of care procedures listed in the study that will be
billed to insurance? ____Yes ____No ____N/A
If sponsor contracts to pay for “evaluable” subjects, is the definition of
an evaluable subject clear and acceptable to you? ____Yes ____No ____N/A
If the study is canceled prior to enrollment, will the sponsor pay for
pre-study activities? ____Yes ____No ____N/A
Are there any administrative costs that may be incurred by UMH for:
· Protocol amendments (may require consent form revision)? ____Yes ____No ____N/A
· Re-consenting subjects? ____Yes ____ No ____N/A
· Unanticipated monitoring visits? ____Yes ____No ____N/A
· Unexpectedly high number of SAEs? ____Yes ____No ____N/A
· Audits? ____Yes ____No ____N/A
Are potential administrative costs acceptable? ____Yes ____No ____N/A
Will sponsor pay for an adequate number of screen failures (especially
important for difficult protocols)? ____Yes ____No ___N/A
Will sponsor pay for study record storage? ____Yes ____No ___N/A
Will the proposed payment schedule allow you to keep afloat, e.g.,
adequate up-front payment; payments paced according to work required
by protocol? ____Yes ____No ____N/A
Will sponsor pay for informed consent translations? ____Yes ____No ____N/A
What is the cost of the drug/device/agent? ____Yes ____No ____N/A
If using an investigational device, what is potential reimbursement
shortfall? ____Yes ____No ____N/A
Is potential shortfall acceptable? ____Yes ____No ____N/A
OTHER
Does the sponsor expect this study to be audited by the FDA? ____Yes ____No ____N/A
(FDA audits take staff time.)
Will sponsor’s site monitor visit frequently? (Frequent visits
will consume staff time but may help to minimize the number of data queries.) ____Yes ____No ____N/A
REVIEW FINAL ASSESSMENT/OPINION
Approval No changes: there is an acceptable risk/benefit ratio and protocol is acceptable as submitted
Conditional Approval Minor changes needed the informed consent document. Protocol or other study materials
Disapproval Risks significantly outweigh the benefit or value of the knowledge to be gained
Comments: ______
______
Signatures:
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PI: Print and Sign Date
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UMH: Print and Sign Date
If you have any questions regarding UMH Questionnaire, please contact 305-689-5410.
Version 11/12/2013 Page 5 of 5