Resources For Investigators

Clinical Research Services (CRS) is designed to be a portal through which clinical investigators access streamlined coordination of services necessary to initiate clinical research projects, regardless of funding source. We support all clinical research studies, providing staff and/or services to manage your study from beginning to end according to Good Clinical Practice and federal, state and institutional regulations and guidelines. We can also facilitate survey research, large data set analyses, and psychometrics.

Available Services 

• Clinical research project consultation, study design assistance
• Protocol development and feasibility
• Regulatory/IRB document preparation services
• Clinical research budget development, including research pricing
• Data collection for subject tracking to ensure proper invoicing/revenue capture
• Clinical research training
• Overall study management provided by certified and extensively trained clinical research coordinators, including:
  • Creation of source documents that facilitate systematic data collection and/or aid in protocol execution and management including:
    • Obtains informed consent/assent
    • Collection of subject data; completion of data collection forms and submission to sponsor
    • Maintenance of IRB/regulatory documents
    • Advocacy for the research subject and family
    • Performance of study procedures; specimen collection and processing
    • Coordination of subject study visits with other hospital services
    • Administration of investigational medications
    • Procedure such as venipuncture, IV insertion and injections; PK capability
    • Coordination of monitoring visits by sponsor representative

Intramural clinical and translational research grants are available on a competitive basis to all Nationwide Children’s Hospital faculty. Clinical Research Services oversees this program by providing support for the application process, scientific review, and administrative oversight. Investigators holding faculty appointments at The Ohio State University with a primary appointment at Nationwide Children’s Hospital may apply for funding through this program with approval of their division director or department chair.

Applications are accepted quarterly on the first Monday of April, August and December before 5 p.m. and can be submitted electronically to Clinical Research Services. Funded investigators are required to present their research study at a the Abigail Wexner Research Institute educational program and to submit a written progress report every six months. An end of study report must be submitted within thirty (30) days of the end date of the project.

Information for Faculty

More information is available to faculty, including applications for Intramural Funding and for Research Release Time.

• Access the employee intranet (ANCHOR) page for Clinical Research Services Intramural Funding: anchor.columbuschildrens.net/crs-intramural-funding

• Contact IntramuralFundingCommittee@NationwideChildrens.org for more information.

Note: You must be connected to Nationwide Children’s server in order to access this information.

Research Release Time is designed to “buy out” clinical time for physicians with primary clinical responsibility so that a clinical or translational research project can be successfully completed. The goal is to have an investigator’s time and effort on every research project either paid for by a grant or with Research Release Time. In the Department of Pediatrics, applications for up to 12 months of Research Release Time are accepted on a quarterly basis and can be submitted electronically to Clinical Research Services. Applications must be reviewed and approved by the Division Chief and Department Chair prior to submission.

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

More information is available to faculty, including applications for Intramural Funding and for Research Release Time.

• Access the ANCHOR page for Research: anchor.columbuschildrens.net/pediatric-research
• Under "Shared Resources" on the left list of links, click on "Clinical Research Services (CRS)"

Note: You must be connected to Nationwide Children’s server in order to access this information.