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14 Calendar Days

The IRBMED office should receive reports within 14 calendar days of the event or investigator's receipt of notification of the event. (Because the reporting of Adverse Events can be a time-sensitive issue researchers are encouraged to establish a system for logging or date-stamping information related to Adverse Event notifications and reports from subjects, sponsors and other sources.)

21 CFR…

Title 21 - Food and Drugs: Title 21 of the Code of Federal Regulations houses all the regulations related to the Food, Drug and Cosmetics Act can be found.  Some of the more popular are:

Part:

               

11: Electronic Records; Electronic Signatures

50: Protection of Human Subjects

54: Financial Disclosure by Clinical Investigators

 

Part:

                      

56: Institutional Review Boards

312: Investigational New Drug Application

812: Investigational Device Exemptions

45 CFR 46

Title 45, Part 46 of the Code of Federal Regulations covers the Protection of Human Subjects. These regulations govern human subject research conducted by all federal agencies. Together, this body of regulations governs the conduct of human subject research today. 45 CFR 46 Subpart A is often called the Common Rule as nearly all divisions, centers or institutes within the DHHS has agreed to follow the regulations in the protection of human subjects.

510(K) Device

A medical device that is considered substantially equivalent to a device that was or is being legally marketed. A sponsor planning to market such a device must submit notification to the FDA 90 days in advance of placing the device on the market. If the FDA concurs with the sponsor, the device may then be marketed. 510(k) is the section of the Food, Drug and Cosmetic Act that describes premarket notification; hence the designation "510(k) device."

7 Calendar days

The IRBMED office should receive reports within 7 calendar days of the event or investigator's receipt of notification of the event. (Because the reporting of Adverse Events can be a time-sensitive issue researchers are encouraged to establish a system for logging or date-stamping information related to Adverse Event notifications and reports from subjects, sponsors and other sources.)

AAHRPP

Association for the Accreditation of Human Research Protection Programs

ACCR

Advisory Council on Clinical Research

ACRP

Association of Clinical Research Professionals

Active

A study that is open to accrual

ADA

American Dental Association

Adverse Drug Reaction (ADR)

All harmful and unintended responses to a research use of a medicinal product (drug) related to any dose should be considered adverse drug reactions. The phrase "responses to a medicinal product" means that a causal relationship between the drug and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out.

Adverse Event (AE)

Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio. The FDA also includes in its definition abnormal preclinical or laboratory findings which may not yet have resulted in direct harm to subjects (e.g., a bacteria is identified in a culture from the same batch of cells used to produce a vaccine which has been administered, even if no cases of infection have been reported). The event may or may not be caused by an intervention (e.g., headache following spinal tap, death from the underlying disease, car collision). Adverse Events also include psychological, social, emotional, and financial harms. See also Serious Adverse Event and Adverse Drug Reaction.

Adverse Reaction

An undesirable and unintended effect, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy). Onset may be sudden or develop over time. See Adverse EventSide Effects.

AE

Adverse Event

Affiliated

IRB membership status designating association with the University. A member (or alternate) is considered to be affiliated if he/she or a member of his/her immediate family is a current or past: employee (full or part-time); clinical, adjunct, or visiting faculty member or instructor; healthcare provider holding credentials to practice; volunteer working at the University (unrelated to IRB service); or University consultant or advisor (paid or unpaid). An emeritus faculty or retired staff member is also considered to be affiliated if he/she has been retired or involved in paid or unpaid University activities (including research or service). Current undergraduate, graduate, and postdoctoral students are also considered to be affiliated, as described by UM HRPP policy.

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