CFR: Code of Federal Regulations

Cytotoxic: Any compound or substance that is detrimental or destructive to cells. This includes chemotherapeutic agents.

FAID: Fiscal Authority Identification

FDA: Food and Drug Administration 

Hazardous: Hazardous materials in this context may include cytotoxic, chemotherapeutic, or investigational drugs with an unknown risk to the health of humans. Materials may be full or partial containers, containing more than 3% of their original volume at the point of disposal, and any items soiled in the making of these medications (eg. preparation mats, spill kits).

Industrial Account Number: An account number, provided by Patient Billing Services (PBS) specific to a study that allows for billing for any and all transactions that are directly related to dispensing. This number will always begin with the prefix '1000' and will always be followed by a 5 digit number. Example: 100012345

Informed Consent: A document required under federal regulation and reviewed and approved by the OHSU Institutional Review Board (IRB) that describes the rights of the study participants and includes details about the study such as duration, treatment, procedures, risks, benefits and key contacts. After review of the document, the participant decides whether or not to sign the document and participate in the study. Informed consent is not a contract and the participant may withdraw from the trial at any time. All research subjects must review and sign an informed consent form prior to study participation.

IRB: Institutional Review Board: An Institutional Review Board is usually made up of physicians, statisticians, researchers, community advocates and others. The responsibility of the board is to evaluate all research that is conducted with human subjects, regardless of funding to ensure ethical treatment and protection of the rights and welfare of all research subjects. All clinical trials must be IRB approved prior to commencement of the trial. According to the FDA and federal regulation, every institution that conducts or supports biomedical or behavioral research involving human participants must have an IRB that initially approves and periodically reviews the research in order to protect the right of enrolled patients. Research activities included under the federal definitions are the collection of tissues, blood, genetic material, private information and any chart review. No research involving human subjects under the auspices of OHSU can be done without IRB approval.

Oracle Grants Accounting (OGA) Alias: An account number, specific to a study, provided by Sponsored Projects Administration (SPA) that allows for billing of administrative fees. This number will usually begin with the number '9' for research protocols and will consist of 8 numerical digits.

P&T Committee: Pharmacy and Therapeutics Committee. Oversees the compilation and maintenance of the hospital formulary and establishes and supervises drug utilization policies and practices within the hospital to ensure optimum clinical results and cost effective management of patients. 

Patient/Subject: Individual enrolled to participate in a research protocol.

PI: Principal Investigator: The PI is the individual responsible for the technical aspects and day-to-day management of the study, including ensuring compliance with the financial, administrative and programmatic aspects of the study, assuring responsible conduct of the research and for conducting the research in compliance with all laws, polices, guidelines and regulatory requirements.

Protocol: A study plan in which all clinical trials are based. The plan is designed to safeguard the health of the enrolled patients as well as answer specific research questions such as clinical efficacy in the treatment of a particular disease state.

RPS: Research Pharmacy Services

Investigational Drug: A drug is a research drug if it is a new drug not approved by the FDA for use in humans and those drugs not approved for sale in interstate commerce by the FDA. An Investigational New Drug (IND) application must be filed for its approval by the FDA. This includes any newly invented or discovered substance undergoing Phase I-IV clinical trial investigation, a new combination of two or more drugs, is used in a new way to diagnose, cure, mitigate or prevent disease. Commercially available drugs that may be used in the treatment of new indications, in new patient populations or in a different dosage form or formulation may also be considered research drugs prior to FDA approval.

Study Coordinator: Individual(s) responsible for the coordination of various aspects of a research protocol. Depending on the individual' s scope of practice and type of research study, duties may include enrollment of the patient, obtaining informed consent, scheduling of appointments, ordering of medication and communication among the patient, principal investigator, sponsor, monitor and research drug pharmacist. Unblinding: Revealing patient treatment assignment in a research protocol. Unblinding is done in the event of some adverse events (AEs) where knowledge of the treatment assignment is necessary to effectively treat the subject.

Unblinding: Revealing patient treatment assignment in a research protocol. Unblinding is done in the event of some adverse events (AEs) where knowledge of the treatment assignment is necessary to effectively treat the subject.