STEPS TO STUDY ACTIVATION
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, and associated outpatient clinics and infusion centers. The primary objective of IDS is to assist and support principal investigators in fulfilling their obligations to study patients, the institution, and research sponsors. This involves ensuring that clinical trials are conducted safely, effectively, and efficiently. Investigational Drug Services ensures compliance with all federal, state, hospital, Joint Commission, and IRB regulations related to investigational medications. The IDS facilitates approximately 350 ongoing studies.
Services provided by IDS include:
- Implementing study protocols adhering to IU Health policies, procedures, and applicable regulatory standards
- Ordering, maintaining, and dispensing study drug inventory
- Continuous temperature monitoring in accordance with the National Comprehensive Cancer Network (NCCN) and United States Pharmacopeia (USP) Guidelines
- Preparing sterile IV drugs for hazardous and non-hazardous study medications in USP 797 and 800 compliant environments
- Maintaining drug accountability records
- Developing prescription forms
- Building and reviewing eMARs and order sets
- Maintaining study blinding and/or randomization
- Providing feedback on proposed blinding mechanisms
- Hosting monitor and audit visits
- Consulting on requirements relative to study drugs
For studies using cellular therapies, visit Cellular Therapy and Immune Effector Trials page.
- eMAR builds, order set review, IDS fees may apply
New protocols should be submitted to IDS prior to IRB submission for feasibility and/or a budget for pharmacy services. Contact the IDS team early in the study planning phase. Early involvement allows for better planning and identification of potential challenges in drug management or protocol logistics. This should be done using the IDS Redcap form: 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:
- Submitting a feasibility survey is not necessary if sufficient information is available for IDS to prepare a budget.
- Drug costs at the time of purchasing will be passed onto the sponsor, which may be more than the quote provided on the budget document. IDS cannot control price fluctuations of products.
To streamline the study initiation process, all paper order set documentation should be completed and quality assurance (QA) checks performed before IRB approval. After IRB protocol approval and the start-up meeting, the lead pharmacist finalizes internal standard operating procedures (SOPs) and prescription forms. The designated personnel will submit the order sets for electronic health record build, when applicable.
Protocol amendments, pharmacy manuals, investigational brochures, and other related documents must be sent to IDS along with IRB approval documentation, if required. Redline copies are preferred if available. Amendments at study start up may affect study activation timelines due to potential rework.
IDS staff must be invited to sponsor site initiation visits, internal initiation meetings (for sponsor–investigator or cooperative group studies), and CRC Inservice sessions, if applicable. IDS must attend pharmacy-specific training to discuss investigational drug dispensing logistics. The study team is responsible for addressing questions about thaw and preparation times to schedule realistic patient visit times. All verbal agreements require email confirmation before IDS can dispense drugs. Specific tasks will be delegated by the PI and agreed upon by the lead IDS Pharmacist after consultation with the study team. IDS may request dedicated time during meetings or a separate review in their office and recommends at least two weeks’ notice for meetings.
IDS Hours
IDS is open Monday – Friday, 8 am – 4:30 pm and observes all IU Health holidays.
Extended hours are available for protocol enrollment and dispensing as outlined below and should only be utilized if agreed upon during start-up. All orders and information required to dispense must be received by the specified cut-off times.
- Monday to Friday: Extended hours start at 4:30 pm. Orders and required information for dispensing must be received by 8:00 pm.
- Saturday and Sunday: Orders and required information for dispensing must be received by 6:00 pm.
A pharmacist is available on call via Backline+ to answer urgent questions about a protocol and monitor the temperatures of locations containing the study drug. Search “IDS” in the schedules section. If unable to reach the pharmacist via Backline, the inpatient pharmacy may be contacted at 317-944-0362 (adult) or 317-944-6667 (pediatric).
Adult IDS–IU Simon Cancer Center (IUSCC)
Shipping Address:
Investigational Drug Services
IUSCC Room C2102
550 North University Boulevard Indianapolis, IN 46202
Phone: 317-944-1900
Fax: 317-968-1496
Email: ids@iuhealth.org
Pediatric IDS—Riley Hospital for Children
*Note: Existing protocols managed by the pediatric team should transition to the new address as soon as possible. All new protocols managed by the pediatric team should utilize the new address.
Shipping Address:
Riley IDS Pharmacy
705 Riley Hospital Drive RM 6130A
Indianapolis, IN 46202
Phone: 317-948-0014
Email: ids@iuhealth.org
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
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/or pediatric investigational drug protocols.
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: IDS page.
Submitting your study to Investigational Drug Services is only one component of study activation. Additional requirements should be reviewed utilizing the Protocol Activation Roadmap Clinical Research Roadmap.