The Research Pharmacy, also known as the Investigational Drug Service (IDS), was established to handle issues related to clinical drug studies. Their service is available to assist investigators conducting drug-related research for subjects at Carolinas HealthCare System, its clinics, and Carolinas HealthCare System Medical Group.
- Limited access to investigational drugs
- Appropriate storage of investigational drugs in accordance with FDA and DEA regulations, as well as, TJC guidelines
- Collection and storage of patient drug returns for reconciliation
- Maintenance of Drug Accountability Records and all study-related files
- Return of all used and unused study drug to the sponsor
- Destruction of expired or used drug on site per approved policies
- Investigational drug dispensing services for all inpatient studies at Carolinas Medical Center (oral medications, admixture/preparation of parenteral medications, cytotoxic/oncologic agents)
- Enroll, randomize, and dispense investigational medications to consented subjects via provided randomization tables, telephone, and/or internet
- Investigational drug dispensing services for Carolinas HealthCare System clinics and Medical Group offices as requested (if feasible)
- Participation in final close-out of study protocols with the sponsor by providing copies of all study drug disposition and inventory control records as required or requested
- Participation in FDA, NCI, NIH, and pharmaceutical sponsor audits/monitor visits
- Assistance with protocol development
- Assistance with randomization schemes and tables
- Development of blinding methodologies
Initiation of a Clinical Drug Study Protocol
Investigators wishing to utilize the Investigational Drug Service must submit a copy of the protocol and Investigator's Drug Brochure prior to IRB submission. The Research Pharmacist will review the protocol to determine the feasibility of IDS participation in the project based on available resources.
The Research Pharmacist will prepare an IDS budget estimate to cover necessary pharmacy costs and submit the budget to the investigator or study coordinator. A list of the applicable fees is available on request.
- Development of educational materials and/or in-service training for medical and nursing personnel
- Assistance with pre-printed physician order forms
- Preparation of oral, topical, and parenteral dosage forms and matching placebos
- Compounding of active drug or placebo capsules, or suspensions
- Other special services as needed for study conduct
Ryan Bender, PharmD
Supervisor, Investigational Drug Services
6:30 a.m. - 4 p.m.
Monday - Friday
||Investigational Drug Services
Attn: Ryan Bender, PharmD
1025 Morehead Medical Drive, Suite 600A
Charlotte, NC 28204