OHSU

Glossary of Terms

Alias: 

Oracle Grants Accounting (OGA) account number, specific to a study, provided by Sponsored Projects Administration (SPA) 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: 503 494-0355 spa@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.

Contact information: 503 494-4261 or e-mail

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 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. Informed consent is not a contract and the participant may withdraw from the trial at any time.


Investigational Drug:

A drug under study but does not have permission from the FDA to be legally marketed and sold in the United States.  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. 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.

 

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 ensure ethical treatment and protection of the rights of enrolled 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 subjects.


NDA:

New Drug Application. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.


NIH:

National Institute of Health


OHSU Investigator Initiated Study:  

Clinical trial 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 activity.

 

PBS: 

Patient Business Services. Contact information: 503 494-8760

 

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.

 

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.

 

Principal investigator: 

The principal investigator or medical researcher in charge of carrying out a clinical trial's protocol. This includes obtaining IRB approval as well as informed consent of participating individuals, patient evaluation and monitoring and provision of medication and medication orders valid under the protocol

 

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.

 

Research Staff: 

Individual(s) involved in 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 two research pharmacists, two research pharmacy technicians, and an administrative coordinator. A licensed registered pharmacist is on call 24 hours a day 7 days a week. 

Contact Information: 503 494-6865 Fax 503 494-1096 or e-mail.

SPA:

Sponsored Projects Administration. 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: 503 494-0355 or e-mail.

Study Coordinator:

Nurse or other health care worker assigned to be the primary liaison with the principal investigator for each protocol. Individual(s) responsible for the coordination of various aspects of a research protocol. 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 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 clinical trial, 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 routine monitoring visit.

 

Study Sponsor:

Individual(s), company or institution responsible for initiation, management and financing of a clinical trial.

 

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.