Investigational Drug Service
Investigational Drug Service
The Vanderbilt University Medical Center Department of Pharmaceutical Services includes an Investigational Drug Service (IDS). The IDS provides assistance to:
- Investigators in accomplishing drug-related research goals,
- VUMC to remain compliant with FDA and Institutional Review Board regulations and
- VUMC for adherence to the standards of the Joint Commission for Accreditation of Health Care Organizations (JCAHO), all applicable federal, and state regulations.
General Information:
An investigational drug may be a chemical or biological product for therapeutic or diagnostic use in humans which has not been licensed by the Food and Drug Administration for distribution in the United States or a licensed product being used in accordance with a research or treatment protocol.
Confidentiality:
The IDS works under the medical center's policies on confidentiality and those policies provided by the research sponsor. It recognizes the confidential and proprietary status of information provided by sponsors of research for the purpose of conducting clinical trials. As appropriate, this information is shared with staff directly involved in the study and with those responsible for the care of patients participating in a study. All Health Insurance and Portability Accountability Act regulations are maintained by the IDS.
Facility and Staffing:
The IDS is located in the Central Pharmacy. The area has equipment necessary to store, prepare, and dispense all categories and dosage forms of drugs and biologics. IDS pharmacists and technicians along with other supporting pharmacy personnel provide services to faculty, investigators, pharmacy staff, nursing staff, and subjects enrolled in research protocols. IDS staff members are available on all clinic days, Monday through Friday 0700 - 1630. Key staff in the Central Pharmacy provide dispensing support twenty-four hours a day when the IDS staff are not present.
Professional Review of Orders:
The pharmacist reviews each investigational drug order in relation to all known factors concerning the patient.
The pharmacist confirms that the request is initiated by an approved investigator available on the FDA 1572 form or approved prescriber's list.
The pharmacist ensures that the consent form is correct indicating that IRB approval is in date and that the study has not enrolled more than the IRB approved number of subjects.
If questions arise, the IRB, the physician, the study nurse or coordinator is contacted for clarification.
Orders are verified against the protocol.
Inpatient orders for investigational drugs received after the IDS is closed are reviewed and processed by the Central Pharmacy staff.
Dispensing Procedures:
Study notebooks are prepared for every research study. They contain sections for: Randomization schedule, Drug Accountability Records, Drug Receipt Records, Subject scripts and consent signature pages, Drug Order Forms (if applicable) or information on how to get a re-supply of drug, and any other miscellaneous forms needed. For all studies, a protocol specific procedure sheet is prepared.
Each patient's order is verified with the protocol assigned and with the patient's dispensing history prior to dispensing any study medications. Discrepancies are discussed with the study nurse or physician, as appropriate. The signature page of the consent form is copied or faxed to the pharmacy for inclusion in pharmacy files.
The protocol is reviewed for all pharmaceutical information prior to attempting to prepare a study medication. A pharmacy protocol specific procedure sheet is reviewed before drug preparation is set up by the pharmacist processing the order.
All investigational drug supplies handled by the pharmacy are maintained by the Central Pharmacy area.
The IDS provides training to essential staff to provide service to protocols that require continuous service 24 hours per day, 7 days per week, 365 days per year.
Record Keeping and Record Retention:
Drug accountability records are maintained by IDS pharmacists in compliance with state and federal regulations and the specific requirements of each protocol.
Such records are maintained for 2 years following the date a marketing application is approved for the drug for the indication for which it was investigated; or if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified. (CFR 21:312.62c)
Quality Assurance:
The quality assurance guidelines established by clinical research sponsors and monitoring agencies, state and federal regulations and the policies of the institution are followed when dispensing investigational agents. Pharmacy dispensing errors, protocol violations, or drug inventory discrepancies are reported in detail to the Assistant Director of Pharmacy, the sponsor, and the principal investigator or study coordinator, along with a description of steps taken to prevent a recurrence of a similar error.
Budget Preparation for Investigators:
Click on the template links to view budget information and considerations for a study - a Vanderbilt ID & password are required. The templates can be printed and used to perform cost estimates.