Investigational Drug Services

Harris Health System's Investigational Drug Service (IDS) Department supports all clinical drug-related research conducted by investigators at all Harris Health locations, including both the inpatient and outpatient settings. The IDS provides the support needed to ensure safe and efficient handling of clinical drug materials, including compliance with federal, state and The Joint Commission's requirements regarding investigational drugs.


Services provided:

• Assistance with protocol development and participation in study initiation visits
• Development of protocol-specific physician order forms
• Randomization schemes
• Blinding methodologies
• Development of educational materials/in-service training for staff
• Preparation of a variety of dosage forms and matching placebo
• Appropriate storage of investigational agents according to FDA guidelines
• Limited access and security of study drug
• Maintenance and control of investigational drug inventories
• Collection of all patient drug returns and reconciliation
• Maintenance of drug accountability records and all study related files
• Participation with the sponsor in final study close-out
• Return or destruction of all used and unused study drug
• Participation in FDA, NCI, NIH and pharmaceutical sponsor audits
• Permanent storage of all clinical study records following study closure


Pharmacy fees
The IDS staff will review the protocol to determine pharmacy feasibility and prepare a fee schedule. The IDS prepares a budget for each study regardless of the funding source. Studies with minimal financial support can be accommodated.

Pharmacy fees generally consist of:

• Set-up Fee: a one-time assessment for establishing and administering the protocols at each Harris Health pavilion. Protocols conducted at multiple pavilions will be assessed a set-up fee for each Harris Health location.

• Dispensing Fee: a standard fee for each dose dispensed or each prescription filled.

Contact Investigational Drug Services for general pharmacy information or pharmacy pricing.

Michael George, PharmD
Coordinator, Investigational Drug Services
Phone: 713-873-4457
Fax: 713-873-4455
E-mail: invdrugs@harrishealth.org

 



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