September 2020

The Johns Hopkins Bayview Medical Center, in collaboration with the Johns Hopkins University, School of Medicine, provides Pharmacy Service to assist investigators with their clinical research conducted on the Bayview campus. In addition to the Main IDS Pharmacy in the hospital, Bayview IDS has research pharmacy satellites in the Asthma & Allergy building, Sidney Kimmel Comprehensive Cancer Center Clinic and the ICTR Clinical Research Unit. The Bayview Investigational Drug Service (Bayview IDS) has dedicated personnel to ensure that the storage, control, preparation and dispensing of drugs used in clinical trials meet all regulatory and hospital requirements. In addition, routine audits are conducted to ensure quality control.

The Clinical Research Pharmacists for Bayview IDS have experience in developing protocols, institutional review board submissions and conducting clinical trials. Additionally, we provide services that include, but are not limited to: study drug preparation & dispensing, subject randomization, handling hazardous compounds, placebo preparation & blinding, drug information, simple random-code generation, preparation of investigational drug data sheets for IRB submission, assistance with the preparation of Investigational New Drug (IND) FDA application, in-service on drug research topics and drug acquisition for investigators.

Our personnel, resources and experience have given us the ability to successfully support a wide variety of research proposals, from small, investigator-initiated studies to large, Multi-center, government or industry sponsored trials.

Budget estimates for Research Pharmacy Services are provided to investigators after review of the available protocol information. If the information changes, then the budget would need revision.

The time and cost impact on the Bayview IDS are categorized accordingly:

• Study Setup & Initiation: This fee occurs only once. It pertains to the time involved in reviewing the protocol and related documents, developing dispensing procedures, in-servicing staff, attending start up meetings, and any effort for IDS to prepare for a study;
• Study Maintenance: This pertains to the cost of procuring drug or receipt of shipments, drug storage, temperature monitoring, inventory control and record keeping, as well as monitor visits (when applicable);
• Study Drug Preparation & Dispensing: Pertains to the time involved for randomization (if applicable), preparation, and dispensing of study drug. The cost of miscellaneous supplies that are not provided by the sponsor of the study are included separately; and
• Close-out Cost: This pertains to study drug return or destruction, and storage of pharmacy regulatory records.

All billing reflects the work performed during the indicated period. Bayview IDS does not work directly with sponsors regarding contracts or budgets for supported trials. The proposed budget is between Bayview IDS and the Principal Investigator.

Auditing

Research protocols involving Investigational New Drugs (INDs) that are approved by the IRB for the investigator to handle on the Bayview Campus and not dispensed by IDS must be audited by a Clinical Research Pharmacist. Routine audits will be conducted at initiation, shortly after patients are enrolled, prior to yearly IRB renewal, and upon termination of the protocol. This is to ensure that the storage, control, preparation, and dispensing of drug(s) used in clinical trials meet all regulatory and hospital requirements.

For further information on how Bayview IDS can support your study needs, please call (410) 550-2747 or contact a Clinical Research Pharmacist at the following e-mail address: [email protected].