ESSENTIAL SERVICES
COMPANION SERVICES
IU Health Investigational Drug Services
- Coordinating drug studies across the IU Health system
Investigational Drug Services (IDS) is part of the Indiana University Health Pharmacy Department. All Indiana University Institutional Review Board (IRB)-approved clinical trials requiring study drugs to be dispensed or administered within any IU Health facility must be coordinated through the Adult Academic Health Center (AAHC) IDS. The AAHC IDS involvement includes but is not limited to clinical trials conducted at University Hospital, Methodist Hospital, Riley Hospital for Children, IU North Hospital, IU West Hospital, and associated outpatient clinics and infusion centers.
The IDS facilitates approximately 350 ongoing studies.
- Services provided by IDS include:
- Operationalizing study protocols to ensure adherence to IU Health policies and procedures
- Study drug inventory ordering, maintenance, and dispensing
- IV drug preparation
- Drug accountability record maintenance
- Prescription form development
- Cerner builds and order set development
- Study blinding and/or randomization maintenance
- Hosts monitor review visits and audit reviews
- Protocol or IRB consultation on requirements relative to study drugs
This summary is designed to aid the research coordinator, data manager, and study monitor to make the most effective use of our services.
IDS Hours
IDS is open Monday – Friday, 8 am – 4:30 pm, and observes all IU Health holidays.
A pharmacist is on call to answer emergent questions about a protocol and to monitor temperatures of locations containing study drug.
The contact can be found in Diagnotes by searching “IDS” in schedules. Alternatively, you may call the inpatient University Hospital pharmacy and they can connect you with the IDS team member on call.
Drug Shipment Address / IDS Office Address
Investigational Drug Services
IUSCC Room C2102
550 North University Boulevard
Indianapolis, IN 46202
Billing Address for Purchase Orders
IU Health Investigational Drug Services
University Hospital AOC, 6201
550 North University Boulevard
Indianapolis, IN 46202
Buy IU Supplier Number
P30193343
IDS
Email: IDS@iuhealth.org
Phone: 317.944.1900
Fax: 317.948.1496
IDS Staff
IDS is staffed by licensed pharmacists and pharmacy technicians whose professional focus is investigational drugs. All pharmacists have extensive experience with managing adult and pediatric investigational drug protocols.
Monitor Visits
Routine monitor visits are scheduled at least 4 weeks in advance. Requests for documentation (temperature logs, shipping documents, training logs, etc) will be handled as a monitor visit. If a monitoring plan requires an initial visit to occur within a certain time of the first patient’s treatment, please communicate that at the time of scheduling and IDS will try to accommodate. Email IDS@iuhealth.org or call 317.944.1900 to schedule.
Interactive Response Technology (IRT) / EDC Access
IDS responsibilities are limited to verification or confirmation of study drug receipt or confirmation of a dispense at the time of dispense in an IRT system. IDS personnel cannot support enrolling subjects, entering subject data, or entering drug accountability data (or perform reconciliation) within an IRT when accountability is documented in Vestigo. IDS cannot support entering a system to determine treatment, lot number, or kit assignment. IDS will not be responsible for entering data into an EDC system. For protocols that require IRT, we require that all technicians have access plus the lead pharmacist. Additional pharmacists may be required to have access on an as needed basis.
Protocol Set-up
If IDS services are going to be used, please complete a redcap request using the website: IDS Pharmacy Budget and Feasibility Request (iu.edu). IDS will prepare a budget for the sponsor for pharmacy services.
After the protocol has received IRB approval and the start-up meeting has occurred, the pharmacists will finalize the internal standard operating procedures, preprinted prescriptions, arrange for Cerner computer drug activation, and provide advice on inpatient order development.
We request that copies of any protocol amendments be forwarded to IDS or IDS notified that changes have been submitted to the IRB and the appropriate computer website/program to find the amendment (e.g. ONCORE).
The IDS staff must be a participant in the sponsor’s site initiation visit or the internal site initiation meeting (for sponsor–investigator or cooperative group studies). It may be necessary for IDS to request a specific time during the meeting for the study drug review or a meeting in the IDS office. IDS recommends a minimum of 2 weeks’ notice for meetings.
Patient Orders / Prescription Dispensing Process
A protocol medication cannot be prepared without receipt of an accurate and completed prescription/order and IRT (if applicable). All requests for protocol medication are processed in the order in which they are received if a specified pick-up time or administration time is not listed. Per CFR 312.6, all IP dispensed from IDS will have, “Caution: New Drug – Limited by Federal (or United States) law to investigational use.”
Records Storage
Study materials (accountability logs, drug receipt records, etc.) are returned to the principal investigator at the close of the study for long-term storage.
Compounding Hazardous Products
Closed System Transfer Device (CSTD) system will be used to compound all injectable hazardous agents in a biological safety cabinet to minimize exposure using proper technique and equipment in accordance with USP 800, IU Health Policy, and IDS procedures. There is a potential risk of exposure wherever hazardous medications are received, stored, prepared, administered, or disposed. Exposure may occur via inhalation of an aerosolized drug or droplets, absorption through the skin, accidental injection, or ingestion through contact with food or contaminated hands. Currently, IU Health utilizes Equashield as our standard CSTD.
Per the National Comprehensive Cancer Network (NCCN) investigational service consensus recommendations, research pharmacies should follow their institution’s applicable policies and risk assessment for handling of any IP that is deemed hazardous.
- “In the absence of incompatibility evidence between the CSTDs fluid pathway components and IP, CSTDs will be used for compounding as dictated by local policy.”
- “IDS should use their locally sourced CSTD supplies due to familiarity and increased safety when compounding and administering hazardous drugs.”
- “Clinical trial sponsors should be willing to prospectively test IP with CSTD products if compatibility is a concern.”
Patient Returns
IDS will not save any used IP, packaging or materials from patient returns. The IP and/or packaging will not be saved for monitor reconciliation or returned to the sponsor. These will be destroyed following the standard Document and Destroy Procedure. IDS will not accept any returns that are considered a biological hazard.
Used IP from Sterile or Non-Sterile Preparations
IDS will not save any IP or packaging that was used for preparation. Once the product has entered the preparation area, no materials will be removed or saved. These materials are placed for destruction upon preparation.
Standard Temperature Ranges for Investigational Drug Storage
Storage Location
Temp. Range
Reportable Temperature Excursions
Controlled Room Temperature
20 ºC to 25 ºC
A temperature > 5º out of the standard temperature range for a sustained period of > 2 data points (approximately 30 minutes).
Refrigerated Temperature
Freezer Temperature
2ºC to 8 ºC
-25 ºC to -10 ºC
A temperature > 1º out of the standard temperature range for a sustained period of > 2 data points (approximately 30 minutes).
Freezer, Ultra Low Temperature
-90 ºC to -65 ºC
A temperature > 5º out of the standard temperature range for a sustained period of > 4 data points (approximately 60 minutes).
- National Comprehensive Cancer Network investigational drug service consensus recommendations, American Journal of Health-System Pharmacy, Volume 79, Issue 6, 15 March 2022, Pages 486–491, https://doi.org/10.1093/ajhp/zxab455.
- US Pharmacopeia. General notices and requirements. Applying to standards, tests, assays, and other specifications of the United States Pharmacopeia. Accessed June 4, 2024. https://www.uspnf.com/sites/ default/files/usp_pdf/EN/USPNF/ generalNoticesandRequirementsFinal.pdf