Research A to Z

This agreement is used when one institution engages in research with: A performance site with whom institution ‘a’ currently does not have a Cooperative Review Agreement and Only one institution's IRB will review the study to avoid the need for dual review - Either institution ‘a’ or the performance site.

Institutional Review Board for Health Sciences and Behavioral Science

Junior Associate Regulatory Analyst

Individual who manages the study protocol (i.e. consenting, IRB applications, scheduling patients, monitor visits, data entry, query resolution, etc.)

A HIPAA-specific term, denoting a dataset that contains PHI with only indirect HIPAA identifiers. Specifically, the following types of HIPAA identifiers may be included:

• Geographic subdivisions smaller than a state.
• All elements of dates (except year) for dates that are directly related to an individual; and all ages over 89 and all elements of dates (including year) indicative of such age
• Any other unique identifying number, characteristic, or code

See Research A-Z webpage Limited Data Sets for guidance on the requirements for using or disclosing an LDS.

An event which occurs in a study under the supervision of the UM IRBMED and whose principal investigator is a UM faculty or staff member. The event is a UM Event when it occurs at UM (including any UMHHC, or other facility) or any other site where the UM PI has oversight, even when the PI is physically in another location. It does not matter where the subject experiences or is treated for the adverse event. If interventions take place at several different UM locations, please specify at which location the event occurred.

Study designs comparing two or more interventions in which either the investigators, the subjects, or some combination thereof do not know the treatment group assignments of individual subjects. Sometimes called "blind" study designs. See also: Double-Masked Design and Single-Masked Design

The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity.

• A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body (that is, not a drug or biologic). Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment. (OHRP)
• A medical device is any instrument, apparatus, or other similar or related article, including component, part, or accessory, which is… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals… The range of devices is broad and diverse, including bandages, thermometers, ECG electrodes, IUDs, cardiac pacemakers, and hemodialysis machines. For further information, see the following FDA guidance:
  • Medical Devices
  • Frequently Asked Questions about Medical Devices
  • Significant Risk and Nonsignificant Risk Medical Device Studies

The patient-centric electronic health record (EHR) system used by more than 26,000 members of the Michigan Medicine community.

MCRU provides the clinical staff, resources, and infrastructure necessary to conduct human clinical research protocols at the UM. MCRU hosts investigators funded by federal, state, and local agencies as well as those funded by the private sector. MCRU also serves as an institutional resource for investigators to perform pilot studies that may result in further agency funding. Investigators whose research protocol is federally, departmentally, or philanthropically funded currently can access resources and services without fee. Industry-sponsored studies are billed differently but all research discounts apply.

The process by which a specification (built & delivered by Nimblify) is updated by CRAO to encompass the level of detail needed for successful subject management, account reconciliation and charge routing at U of M.

MIAP was established to provide comprehensive regulatory support, guidance, and education services to faculty investigators involved in US FDA regulated clinical research at UM. MIAP's primary focus is to offer regulatory assistance to sponsor-investigators of a new drug, biologic or medical device to ensure clinical research excellence and regulatory compliance, as set forth by the UM and the FDA. The MIAP program offers regulatory assistance to Investigators planning to utilize either a drug or biological product classified by the FDA as an IND per 21 CFR 312, or an investigational medical device subject to IDE regulations, per 21 CFR 812.

• Generally: “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life or during the performance of routine physical or psychological examinations or tests”  45 CFR 46.102(i)
• Prisoners:  “Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy person"  45 CFR 46.303(d)

An event which causes discomfort and perhaps requires treatment, but does not pose any significant or permanent risk or harm to the subject or require in-patient hospitalization. An event that is Grade II by CTC Common Toxicity Criteria.

A single study that involves more than one research center.

National Cancer Institute

The protocol identifier assigned by clinicaltrials.gov.

National Institute on Alcohol Abuse and Alcoholism