Investigational Drug Service (IDS)

The Investigational Drug Service (IDS) is a function of the Department of Pharmacy and provides support to ensure the safety and efficiency of all clinical drug trials at Nationwide Children’s Hospital.  Standard MM.0601.05 of The Joint Commission has mandated: 

“The critical access hospital’s written process for the use of investigational medications specifies that the pharmacy controls the storage, dispensing, labeling, and distribution of investigational medications.”

In an effort to comply with The Joint Commission, the Ohio State Board of Pharmacy, and the Food and Drug Administration (FDA) standards, Nationwide Children’s Hospital has instituted policies requiring the IDS to manage all investigational pharmaceutical products dispensed in clinical trials. This includes:

• FDA approved medications
• Over-the-counter medications 
• Herbal supplements
• Investigational New Drug (IND) or research-grade products
• Investigational devices requiring an IND

As a fee-for-service program, the IDS will initially review each protocol and determine an estimated study budget. Fees are dependent on the number of subjects anticipated, the duration of the study, and the extent to which pharmacy services are required. General fees include, but are not limited to:

• Set-up & Close-out Fees
• Dispensing Fees
• Compounding & Consultation Fees
• Maintenance Fees
• Special Handling & Storage Fees

If you would like more information on the fee structure or have specific questions regarding the fees for your study, contact the IDS at PharmacyIDS@NationwideChildrens.org. Please include a copy of your current protocol for all new study budget requests.

IDS Services

Inventory Control

• Ordering, receipt, expiration tracking, and documentation of study drug shipments

Storage

• Limited access storage of all investigational study product, separate from regular pharmacy stock
• Refrigerator, freezer, and locked controlled substance storage for appropriate investigational study product
• Controlled temperature monitoring of all investigational study refrigerators, freezers, and room air

Drug Information

• Preparation of pre-printed prescriptions, drug data sheets, and IV drug cards
• Training of pharmacy staff on investigational drug protocols
• Clinical checking, drug information, or drug interaction checking

Dispensing & Accountability

• Inpatient and Outpatient Pharmacy dispensing complying with all state and federal regulations
• Compounding of oral preparations or sterile products
• Blinding of investigational drugs
• Treatment randomizations
• Subject-specific and overall site accountability of all dispensed study medications
• Accommodation and preparation for pre-site visits, study initiation visits, routine monitoring visits, internal audits, and FDA audits

Study Close-out

• Temperature reports from date of product receipt to product disposal or return
• Proper disposal and documentation or return of all investigational study supplies upon study close-out
• Permanent, secured long-term storage of pharmacy study records

Other

• Patient counseling for outpatient study medications
• Consultation for initial protocol development or Institutional Review Board (IRB) review
• Ancillary department review for clinical drug studies prior to IRB approval

Contact Information

Please ship all investigational products to:
Nationwide Children’s Hospital
Department of Pharmacy
Attn: Investigational Drug Service
700 Children’s Drive, Room LL007 Tower
Columbus, Ohio 43205

Email: PharmacyIDS@NationwideChildrens.org
Telephone:  (614) 722-2168
Fax:  (614) 722-2157

Hours of Operation
Outpatient Studies: 8:00am – 4:00pm
Inpatient Studies: 24 hours a day, 7 days a week