Download IDS Fee Form - UC Davis Health

Investigational Drug Service at UC Davis Medical Center
Description of Investigational Drug Service Fees
Central IDS Pharmacy at
UC Davis Health System
Investigational Drug Pharmacy, Rm 1107
2315 Stockton Blvd
Sacramento, CA 95817
[email protected]
Phone: (916) 703-4093
Fax:(916) 703-7048
Cancer Center IDS Pharmacy
UC Davis Comprehensive Cancer Center
Investigational Drug Pharmacy
4501 X Street, Rm 1008A
Sacramento, CA 95817
[email protected]
Phone: (916)734-7176
Fax:(916) 734-2260
NOTE: This information is provided for reference only. This information is NOT to be
used by researchers to determine the actual IDS fee charges associated with a specific
protocol or proposed study. Actual estimates of UCDMC IDS fees will be outlined in a
formal, written estimate provided to the research team by the IDS staff. IDS estimates
are based on specific information provided in the protocol, investigator brochure and/or
the sponsor-provided pharmacy manual.
Protocol Set-up and First Year Inventory (Standard and Oncology/Cancer Center Trials)
One time, non-refundable fee charged upon pharmacy study activation. Set-up fees include but are not limited
to protocol review, site qualification visits, site initiation visits, development of study specific dispensing
procedures, EMR entry and label design (mandatory), randomization (if needed) provision of GCP-compliant
storage and inventory system including temperature monitoring, IXRS training/set-up, study drug supply
security, creation of pre-printed prescription/order template, quarterly monitoring visits, first year study drug
inventory, in-service training for essential pharmacy personnel, and drug destruction.
Base Protocol Set-up
$2000
Cryogenic Liquid Storage Fee
$250
Additional, non-standard Pharmacy Personnel Training
$100/hour
24 Hour and/or 7 days per week
$250
Protocol Set-up—UCDMC Investigator Initiated Trials
$1500
The Protocol Set-up fee for UCDMC Investigator Initiated Trials applies to UCDMC PI initiated studies only. This
fee requires approval by an Investigational Drug Service Pharmacy Staff Pharmacist. Set-up fees include but are
not limited services detailed above in Protocol Set-up fees for Standard and Oncology/Cancer Center Trials.
Annual Maintenance Fee (Standard and Oncology/Cancer Center Trials)
Annual maintenance and inventory fees will be applied to multi-year studies on the anniversary of the pharmacy
study activation date. The Annual Maintenance Fee covers but is not limited to a monthly study drug inventory
by IDS, study drug accountability, receipt and disposition, scheduled quarterly monitoring visits, temperature
monitoring, and query responses.
Base Annual Inventory Fee
$1000
Cryogenic Liquid Storage/Monitoring Fee
$250
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Annual Maintenance Fee—UCDMC Investigator Initiated Trials
$500
The Annual Maintenance fee for UCDMC Investigator Initiated Trials applies to UCDMC PI initiated studies only.
Annual maintenance and inventory fees will be applied to multi-year studies on the anniversary of the pharmacy
study activation date. This fee requires approval by an Investigational Drug Service Pharmacy Staff Pharmacist.
Annual Maintenance fees include but are not limited to services detailed above in Annual Maintenance Fees for
Standard and Oncology/Cancer Center Trials.
Study Close Out Fee (Standard and Oncology/Cancer Center Trials)
$250
Study closure activities include but are not limited to return or destruction of study drug, archiving of study
documents, final drug accountability and drug destruction (if needed), provision of outstanding documentation
such as temperature monitoring logs, accountability logs, final billing if outstanding balance remains, and
storage of protocol specific documents.
Study Close Out Fee—UCDMC Investigator Initiated Trials
$100
Study closure activities include but are not limited to return or destruction of study drug, archiving of study
documents, final drug accountability and drug destruction (if needed), provision of outstanding documentation
such as temperature monitoring logs, accountability logs, final billing if outstanding balance remains, and
storage of protocol specific documents.
Dispensing Fees
$25-250/dispense
Dispensing fees will be charged based upon protocol specific study drug dispensing requirements and drug
handling and preparation requirements. Dispensing fees will vary based on the complexity of the preparation
(e.g. simple dispense, compounded product, sterile compound, hazardous drug). Dispensing fees are charged
for each prescription number generated. The estimate fee will be calculated based upon maximum chargeable
cost per patient per pharmacy visit. Amount charged may be lower than estimated cost depending on actual
prescribed dosage. UCDMC Investigator Initiated Trials will not be charged dispensing fees. Additional charges
for shipping will apply beyond dispensing fees.
IDS Fee estimates are subject to change upon further review of study materials if necessary.
Pharmacy activity will not commence until signed agreement and required study documents are received by IDS
by the research team.
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