The Investigational Drug Service exists as a satellite area of the Pharmacy Department. The IDS functions independently and in conjunction with the other Pharmacy operations based on the specific clinical trial. It manages more than two hundred drug studies at any given time. The types of trials include industry-sponsored, investigator-initiated, federally-funded, or foundation-funded clinical trials.
The Investigational Drug Service ensures that, no test substance will be dispensed in a clinical trial, without evidence that an informed consent has been first signed at the start of the trial by ensuring the presence of subject acknowledgement within the protocol in an Institutional database through the Committee on Clinical Investigations known as CHeRP (Children’s Hospital electronic Research Portal).
Investigator-initiated protocol randomizations are generated in a cooperative effort between the Clinical Research Program biostatistician, the principal investigator and the clinical research pharmacist. Industry-sponsored study randomizations are usually provided to the IDS.
The IDS maintains independent storage facilities, including refrigerator, freezer, and deep freezer. Dispensing facilities for the clinical research pharmacy allow for the preparation of injectable, oral, topical and rectal pharmaceuticals as well the extemporaneous compounding of agents from API.