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Submit to Investigational Drug Services (IDS)

The Investigational Drug Services (IDS) is part of the IU Health Pharmacy Department. All clinical research studies 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 and extended access programs (EAPs) conducted at University Hospital, Methodist Hospital, Riley Hospital for Children, IU North Hospital, IU West Hospital, Fort Wayne Neurology Center and associated outpatient clinics and infusion centers. The AAHC IDS will establish specific procedures for procurement and dispensation of study drug for each clinical trial. The IDS facilitates approximately 350 ongoing studies.

Services Provided by IDS

Services provided by IDS include:

    • Operationalizes study protocols to ensure adherence to IU Health policies and procedures and regulatory requirements
    • Study drug inventory ordering, maintenance, and dispensing
    • Proper medication storage and 24/7 temperature monitoring in accordance with the National Comprehensive Cancer  Network (NCCN) and United States Pharmacopeia (USP) Guidelines
    • IV drug preparation
    • Drug accountability record maintenance
    • Prescription form development
    • eMAR builds and order set review
    • Study blinding and/or randomization maintenance
    • Hosts monitor review visits and audit reviews
    • Protocol or IRB consultation on requirements relative to study drugs

For studies using cellular therapies, visit the Cellular Therapy and Immune Effector Trials page.

    • eMAR builds, order set review, IDS fees may apply
Protocol Setup

If IDS services are going to be used, please complete a REDCap request using this website: IDS Pharmacy Budget and Feasibility Request (iu.edu) 

      • Choose feasibility to generate a brief list of questions to evaluate the trial’s feasibility. To request a budget after a feasibility request, return to the same form using the unique return code.
      • Choose budget for financial details to assess feasibility and request a budget for IDS services.
      • Please note: you are not required to submit a feasibility survey if you have all information necessary for IDS to provide a budget.

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.

Please send IDS a copy of any protocol amendment or inform them when changes are submitted to the IRB and where to find the amendment (e.g., OnCore). Redline copies are preferred if possible.

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). IDS should also be invited to internal start up meetings involving the Clinical Research Center staff. 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.

Additional Information

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 Backline+ (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.

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.

IDS Locations and Contact Information

Adult IDS–IU Simon Cancer Center (IUSCC) 

Shipping Address:  
Investigational Drug Services  
Shipping Address:
IUSCC Room C2102  
550 North University Boulevard  
Indianapolis, IN 46202
Phone: 317-944-1900
Fax: 317-968-1496
Email: ids@iuhealth.org
Backline+ (Diagnotes): Search “IDS” in schedules to contact the pharmacist on call 

Pediatric IDS—Riley Hospital for Children 

Shipping Address:
Investigational Drug Services  
IUSCC Room C2102  
550 North University Boulevard  
Indianapolis, IN 46202 
Phone: 317-948-0014
Email: ids@iuhealth.org 
Backline+ (Diagnotes): Search “IDS” in schedules to contact the pharmacist on call 

Pediatric IDS – Future shipping address, anticipated to begin transition April 2025
Shipping Address:
Riley IDS Pharmacy 
705 Riley Hospital Drive RM 6130A 
Indianapolis, IN 46202 

Riley Hospital IP Storage locations: 

  • Riley OR/Main IDS Pharmacy Satellite, Room W2801 (2nd floor Simon Family Tower (SFT)) 
  • Riley Inpatient Pharmacy, Room W6130 (6th floor SFT) 
  • Riley Infusion Pharmacy, Room 3400 [3rd floor Riley Outpatient Center (ROC)] 

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

Contacts

IDS
Email: IDS@iuhealth.org
Phone: 317.944.1900
Fax: 317.948.1496

The IDS page on the Office of Clinical Research website includes more information about their services, procedures, and monitor visits. 

Submitting your study to Investigational Drug Services is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.