Glossary of Terms

Aeroscout Mobileview:

A unified web-based electronic asset management system, used by RPS to conduct 24 hour temperature monitoring of investigational medications.

Alias: 

Oracle Grants Accounting (OGA) account number, specific to a study, provided by Office of Proposal & Award Management (OPAM) that allows for billing of administrative fees. The number will usually begin with the number '9' for research protocols and will consist of 8 numerical digits.

Contact information: 503 494-7784, ogahelp@ohsu.edu

Archive:

Storage of documentation. As mandated by federal law, all records involved must be kept for a period of two (2) years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until two (2) years after the investigation is discontinued and FDA is notified. In cases of international study centers, records must be kept for 15 years.

CFR:

Code of Federal Regulations

Cooperative Groups:

To qualify for the "Cooperative Groups" fees, the study must be a study involving a National Cancer Institute (NCI) Clinical Trials Cooperative Group. Defined by the NCI, "The Clinical Trials Cooperative Group Program is designed to promote and support clinical trials (research studies) of new cancer treatments, explore methods of cancer prevention and early detection, and study quality-of-life Cooperative Group Program is designed to promote and support clinical trials (research studies) of new cancer treatments, explore methods of cancer prevention and early detection, and study quality-of-life and rehabilitation issues."

Cytotoxic:

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

IBS:

Internal Billing System. The official OHSU financial systems used for inter-OHSU charging.

Industry Sponsored Study: 

A study funded and designed by a corporate sponsor.

Industrial Account: 

An account number, provided by Patient Business Services (PBS), specific to a study that allows for billing for any and all transactions that are directly related to OHSU healthcare services, including pharmacy dispensing. This number will always begin with the prefix '1000' and will be followed by a 5 digit number.

Contact information: 503 494-8760

Informed Consent: 

A document 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. An informed consent form is not a contract and the participant may withdraw from the trial at any time.

Research Medication:

Investigational, repackaged or relabeled medication intended for administration to research subjects in OHSU healthcare facilities or medications that must be charged to a research account.

IRB: 

Institutional Review Board. An Institutional Review Board is made up of physicians, statisticians, researchers, community advocates and others. The responsibility of the board is to ensure ethical treatment and protection of the rights of research subjects. All research involving human subjects must be IRB approved prior to commencement of the study and reviewed periodically by the IRB (usually annually).

IWRS/IVRS/IXRS:

Integrated Web Response System. System used by study sponsor to track inventory and randomize study patients. If a study utilizes IWRS, RPS personnel will require access to the IWRS system and copies of the randomizations for each dispensation of investigational medication.

NDA:

New Drug Application. The application requesting the FDA approve a new pharmaceutical for sale and marketing in the United States for a specific purpose.

NIH:

National Institutes of Health

OHSU Investigator Initiated Study:  

Clinical study in which a researcher, not a company, has designed and is responsible for conducting a study.

OGA: 

Oracle Grants Accounting. The OHSU financial system utilized to track all sponsored project financial activity.

OPAM:

Office of Proposal & Award Management. OHSU's pre and post award office assists in the fiscal management of sponsored project awards. Contact information: 503 494-7784 or e-mail

PBS: 

Patient Business Services. Contact information: 503 494-8760

P&T Committee:

Clinical Knowledge 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.

Protocol:

A study plan describing all of the activities to be performed in a clinical study. The plan is designed to safeguard the health of the enrolled patients as well as answer specific research questions such as clinical efficacy of a treatment of a particular disease.

Principal investigator: 

The person with primary responsibility for a research study.

Protocol: 

A study plan describing all of the activities to be performed in a clinical study. The plan is designed to safeguard the health of the enrolled patients as well as answer specific research questions such as clinical efficacy of a treatment of a particular disease.

Research Staff: 

Individual(s) involved in a clinical investigation. This includes the study coordinator, principal investigator, study monitor, study sponsor, and Research Pharmacy Services (RPS) personnel.

RPS:

Research Pharmacy Services. RPS is staffed with research pharmacists, research pharmacy technicians, and an administrative coordinator. A licensed registered pharmacist is on call 24 hours a day 7 days a week. 

SPA:

Sponsored Projects Administration, or otherwise known as, Research Proposal Award Management. OHSU's post award office assists in the fiscal management of sponsored project awards, and acts as an institutional intermediary between the OHSU community and the external agencies that provide their funding. 

Contact information: 503 494-7784 or e-mail.

Study Coordinator:

Study personnel assigned to be the primary liaison with the principal investigator for each protocol and responsible for the coordination of various aspects of the protocol. Duties may include enrollment of the patient, facilitating obtaining informed consent, scheduling of appointments, assisting with ordering of medication and communication among the patient, principal investigator, sponsor, monitor and research pharmacist.

Study Monitor:

A monitor is appointed by the sponsor for each clinical study. The study monitor is responsible for overseeing the progress of a study, and for ensuring that the study is conducted, recorded and reported according to the study protocol, standard operating procedures of the sponsor, GCP and local regulatory requirements. All these activities are conducted during a monitoring visit.

Study Sponsor:

Individual(s), company or institution holding the IND for a study (if applicable) and responsible for initiation, management and financing of a clinical study.

Subject:

Individual enrolled to participate in a research protocol

TJC:

The Joint Commission is a private organization that accredits healthcare organizations. Institutions that meet Joint Commission accreditation standards are deemed to meet the Medicare Conditions of Participation, which is a requirement of Medicare reimbursement.

Unblinding:

Revealing patient treatment assignment in a research protocol. Reasons for unblinding include adverse event occurrence or accidental unblinding. All randomization procedures will be followed and unblinding will occur only in accordance with the protocol and existing federal, state and institutional guidelines.

Vestigo:

An online drug accountability system used by Research Pharmacy Service to maintain inventory records and study documentation.