Investigational Drug Services

The Investigational Drug Services (IDS) is part of the Indiana University Health Pharmacy Department. The IDS specializes in investigational drug studies and coordinates studies for both inpatient and outpatient protocols at IU Health University Hospital, Riley Hospital for Children at IU Health, and IU Health Methodist Hospital, and IU Simon Cancer Center.

The IDS facilitates approximately 350 ongoing studies.

  • Services provided by IDS include:
  • Study drug inventory ordering, maintenance, and dispensing
  • IV drug preparation
  • Drug accountability record maintenance
  • Prescription form 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.

Specializing in investigational drug studies makes IDS a unique area of the Department of Pharmacy. We are involved with both inpatient and outpatient protocols at IU Health University Hospital, Riley Hospital for Children at IU Health, IU Health Methodist and satellites.

IDS Location

The IDS pharmacy is located in the IU Simon Cancer Center (IUSCC) Room C2102.

IDS Hours

IDS is open Monday – Friday, 8 am – 4:30 pm, and observes all IU Health holidays.

IDS Staff

IDS is staffed by four full-time licensed pharmacists whose professional focus is investigational drugs. All pharmacists have extensive experience with managing adult and pediatric investigational drug protocols.

The responsibilities of the pharmacists include: reviewing protocols, writing protocol specific standard operating procedures, site initiation meetings with sponsors and staff, and verification of all doses prepared by IDS technicians.

IDS is staffed with five full-time licensed investigational drug technicians who work strictly with investigational drug protocols. Technician responsibilities include: drug preparation and accountability, monitor guidance, billing, patient returns, drug ordering and inventory management. Each technician is assigned to specific therapeutic areas, but all are cross-trained to cover for one another.

Patient Orders/Prescriptions

A protocol medication cannot be prepared without receipt of a completed prescription/order by IDS. All requests for protocol medication are processed in the order in which they are received. While we strive for efficiency in protocol medication preparation, occasionally there may be a delay.

Protocol Set-up

All protocols that involve IDS must have Institutional Review Board (IRB) approval. If IDS services are going to be used, please forward the study protocol to IDS@iuhealth.org. 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 write 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).

A member of the IDS staff will attend the start-up meetings. Due to IDS staffing and meeting constraints, 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.

Monitor Visits

Routine monitor visits are scheduled at least 4 weeks in advance. 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.

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.

IVRS / 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 IVRS system. IDS will not be responsible for entering data into an EDC system. For protocols that require IVRS, we require at least 7 pharmacy team members to have access.

Study Monitors Information

This summary is designed to aid the research coordinator, data manager, and study monitor to make the most effective use of our services.

Specializing in investigational drug studies makes IDS a unique area of the Department of Pharmacy. We are involved with both inpatient and outpatient protocols at IU Health University Hospital, Riley Hospital for Children at IU Health, IU Health Methodist and satellites.

IDS Location

The IDS pharmacy is located in the IU Simon Cancer Center (IUSCC) Room C2102.

IDS Hours

IDS is open Monday – Friday, 8 am – 4:30 pm, and observes all IU Health holidays.

IDS Staff

IDS is staffed by four full-time licensed pharmacists whose professional focus is investigational drugs. All pharmacists have extensive experience with managing adult and pediatric investigational drug protocols.

The responsibilities of the pharmacists include: reviewing protocols, writing protocol specific standard operating procedures, site initiation meetings with sponsors and staff, and verification of all doses prepared by IDS technicians.

IDS is staffed with five full-time licensed investigational drug technicians who work strictly with investigational drug protocols. Technician responsibilities include: drug preparation and accountability, monitor guidance, billing, patient returns, drug ordering and inventory management. Each technician is assigned to specific therapeutic areas, but all are cross-trained to cover for one another.

Patient Orders/Prescriptions

A protocol medication cannot be prepared without receipt of a completed prescription/order by IDS. All requests for protocol medication are processed in the order in which they are received. While we strive for efficiency in protocol medication preparation, occasionally there may be a delay.

Protocol Set-up

All protocols that involve IDS must have Institutional Review Board (IRB) approval. If IDS services are going to be used, please forward the study protocol to IDS@iuhealth.org. 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 write 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).

A member of the IDS staff will attend the start-up meetings. Due to IDS staffing and meeting constraints, 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.

Monitor Visits

Routine monitor visits are scheduled at least 4 weeks in advance. 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.

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.

IVRS / 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 IVRS system. IDS will not be responsible for entering data into an EDC system. For protocols that require IVRS, we require at least 7 pharmacy team members to have access.

Drug Shipment Address

Investigational Drug Services
IU Health Pharmacy
IUSCC Room C2102
550 North University Boulevard
Indianapolis, IN 46202

Contact Information

IDS Office Address

Investigational Drug Services
IU Health Pharmacy
IUSCC Room C2102
550 N. University Blvd.
Indianapolis, IN 46202

Billing Address for Purchase Orders

University Hospital Pharmacy Administration
Pharmacy Administration
University Hospital AOC 6201
550 North University Boulevard
Indianapolis, IN 46202

IDS (all staff access)

Email: IDS@iuhealth.org
Phone: 317.944.1900
Fax: 317.948.1697

Contact

Drug Shipment Address

Investigational Drug Services
IU Health Pharmacy
IUSCC Room C2102
550 North University Boulevard
Indianapolis, IN 46202

Contact Information

IDS Office Address

Investigational Drug Services
IU Health Pharmacy
IUSCC Room C2102
550 N. University Blvd.
Indianapolis, IN 46202

Billing Address for Purchase Orders

University Hospital Pharmacy Administration
Pharmacy Administration
University Hospital AOC 6201
550 North University Boulevard
Indianapolis, IN 46202

IDS (all staff access)

Email: IDS@iuhealth.org
Phone: 317.944.1900
Fax: 317.948.1697