An adverse event is any experience that has taken place during the course of a research project, which, in the opinion of the investigators, was harmful to a subject participating in the research, increased the risks of harm in the research, or had an unfavorable impact on the risk/benefit ratio.   Adverse events may be expected/anticipated (such as a known possible drug side effect) or unexpected/unanticipated.  Expected or possible adverse events should be listed in the Risk Assessment section of the protocol.

Ancillary Services

Services routinely available from hospital departments for all patients in the hospital; e.g., routine blood and urine tests, x- rays, medications, etc.

Clinical Trial Agreement

An agreement with an industrial sponsor that contains the research project; budget; and terms and conditions affecting proprietary information, data rights, publication rights, inventions and patents, and payment schedules and conditions. The agreement is signed by the principal investigator, a representative from UAMS administration, and the sponsor.

Core Laboratory

A facility that supports ongoing sophisticated clinical research and the development or validation of new methods for this purpose.

Industry-Initiated Study

A study initiated by an industrial sponsor with little or no research aims added by a UAMS investigator. Usually these studies are conducted in multiple institutions.

Inpatient Day

One person registered as a UAMS or VAMC inpatient at 12:00 midnight.

NIH Guidelines

The rules and regulations that define and govern the UAMS-CRC. Published by the National Center for Research Resources of the National Institutes of Health.

Outpatient Visit

One person registered as an outpatient who arrives at and departs from the hospital or clinics within a single day.

Patient Categories

NIH's method of assigning financial responsibility of hospitals' costs for patients receiving UAMS-CRC support.

Category A

Patients admitted solely for research purposes. In cases where all subjects would be category A, the study may be termed category A study.

Category B

Patients admitted for routine medical care and who simultaneously participate in a research project.

Category C

Patients admitted but who do not participate in any research project. These patients are typically termed "boarders" on the UAMS-CRC.

Category D

Patients who participate in industry-initiated studies. These studies are typically termed category D studies.

PHS 398

Except for minor exceptions, Public Health Service (PHS) form #398 is used to apply for all new, competing continuation, and supplemental research and research training grant and cooperative agreement support from NIH and other agencies of the PHS.

Publication Credit

Scatter Bed

Some studies require that patients be cared for in areas away from the discrete unit, referred to as scatter beds.

Serious Adverse Event (SAE)

See HRAC IRB Handbook for Investigators Conducting Human Research Studies.