Request CTRI Services
The CTRI Research Pharmacy is a fully operational pharmacy staffed by a fulltime pharmacist and a fulltime technician through our collaboration with the UC San Diego Pharmacy Department. Located at the East Campus Office Building, the investigational drug pharmacy is a temperature-controlled space that includes a refrigerator, a freezer, storage, compounding areas, and a glove box for handling sterile material. It has a general pharmacy license and a sterile compounding license. In the fall, it is scheduled to move into the Altman Clinical and Translational Research Institute Building, inhabiting 1,000 square feet of the Center for Clinical Research (CCR).The addition of the pharmacy to our CCR makes our clinical research operations more efficient, effective, and comprehensive, giving CTRI a full slate of clinical trial services under one roof, from nursing and clinical coordination, to biostatistics and labs, to physician oversight and investigational drug compounding.
Representatives from CTRI and UC San Diego Pharmacy Services recently gathered at the new CTRI Research Pharmacy. From left are: Charles Daniels, PhD, Professor and Associate Dean for Professional Practice, Skaggs School of Pharmacy and Pharmaceutical Sciences; Cindy Adams, RPh, Investigational Drug Service pharmacist; Thaine Ross, CPhT, pharmacy technician; Gary S. Firestein, MD, Director of CTRI, Distinguished Professor of Medicine, Dean and Associate Vice Chancellor of Translational Medicine; and Ji Sun, PharmD, Ph., Investigational Drug Service manager.
Pharmacy services are critical to the success of clinical trials involving experimental drugs. Pharmacists are responsible for procuring and storing drugs; maintaining all records regarding their purchase, regulation, and dispensing; compounding and dispensing study drugs; providing consultations to subjects enrolled in clinical trials; monitoring potential drug side effects in subjects enrolled in the studies; and assuring quality control and compliancy. The CTRI pharmacist is an active member of the research team, helping with the design of the study and participating in protocol review. Our pharmacist ensures that labeling, drug storage, dispensing, and accountability records of all investigational new drugs comply with federal, state, and institutional guidelines. The pharmacy technician is also a critical member of the pharmacy team because he or she works with drug sponsors and auditors, and performs day-to-day compounding, dispensing, record keeping, and billing.
All UC San Diego pharmacies use Epic, an electronic medical record keeping system that minimizes the medication errors normally seen in paper-based records. Also, UC San Diego pharmacy services require all actions to be double checked, including the protocol, dispensing, and treatment time billed. These combined actions heighten safety and ensure quality.
Our on-site pharmacy saves time and removes drug stability issues that could arise during transport. Many investigational drugs are expensive; some need to be thawed and can't be re-frozen. The on-site pharmacy better serves our investigators, clinic staff, and subjects by eliminating drug stability concerns and transport responsibilities, and decreasing wait time.
The CTRI CCR presently supports more than 150 clinical trials – and the number is growing. On-site formulation and administering of experimental medications improve clinical trial safety. The CTRI pharmacy helps us better support all phases of clinical trials, including Phase I, the early phase trials that test a drug's safety during the development of novel treatments.
The CTRI pharmacy is capable of supporting hundreds of clinical trials.
For more information, e-mail Ji Sun, PharmD, PhD, Investigational Drug Service Manager.
Service requests must come through the CTRI website request form in order to receive the approved recharge rates.
Recharge Rates went into effect July 1, 2015.
|Protocol Set-Up – Inpatient/Outpatient Trials
||One time non-refundable fee includes but is not limited to: reviewing the protocol; developing specific dispensing procedures set by the study protocol; creating randomization scheme (if needed); building inpatient order sets in Epic (mandatory); and developing pre-printed orders sets for 7/24 inpatient studies (must be approved by the PI prior to use). In addition, but is not limited to: Investigational Drug Service (IDS) to meet with the sponsor at Site Initiation Visit and during scheduled quarterly monitoring visits; study drug inventory will be accurately maintained and documented; and IDS staff will provide in-service training to nursing and impatient pharmacy studies
|Renewal Fee – Annual
||For multi-year studies, an annual maintenance fee will be applied on the anniversary of the date that the initial Set-Up Fee was applied. The maintenance fee covers, but is not limited to: scheduled quarterly monitoring visits and continuing investigational product management (temperature-controlled storage, regular inventory and documentation, and query responses that occur regardless of medication dispensation).
||Closing Task includes, but is not limited to: conducting close-out visit with the sponsor; performing final drug accountability and drug destruction on site (if needed); completing any inquiries; providing supporting documents such as temperature logs, drug receipts, etc.; completing final billing (if not finalized prior); and storing protocol-specific pharmacy binder (on site up to 12 months, then long-term storage [Iron Mountain] for additional 22 years).
|Fee per Rx Dispensed/Compounded per hour for weekdays
|Fee per RX Dispensed/Compounded per hour for evenings
|Fee per RX Dispensed/Compounded first two hours for weekends, holidays
|Fee per RX Dispensed/Compounded hour 3+ for weekends, holidays
|Fee for Simple Encapsulation (costs of drug and labor are not included):
|Randomization Assignment (flat fee)
|Additional Monitoring Visit beyond the quarterly visits