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REGULATORY LEARNING
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Clinical Investigator (CI)
An individual who actually conducts a clinical investigation, under whose immediate direction the test article is administered, dispensed, or used.
Bioresearch Monitoring Program (BIMO)
Created after 1975-1976 Congressional Hearing which directed FDA to establish an agency-wide program for comprehensive on-site inspections and data audits; designed to monitor all aspects of the conduct and reporting of FDA-regulated research. The BIMO program monitors – Sponsors/Contract Research Organizations (CROs)/Monitors; Institutional Review Boards (IRBs); Clinical Investigators (CIs); Nonclinical Laboratories. BIMO program objectives are to protect the rights, safety, and welfare of human research subjects; assure the quality, reliability, and integrity of data collected. BIMO Program functions include Auditing clinical data; Inspecting ongoing clinical research; Inspecting nonclinical laboratories; Inspect IRBs; Educate, train and Implement FDA’s Application Integrity Policy
Sponsor
Takes responsibility for and initiates a clinical investigation, but does not actually conduct the investigation May be an individual, company, government agency, academic institution, private organization
Monitor
Individual designated by a sponsor or contract research organization to oversee the progress of an investigation; Must be qualified by training and experience to monitor the device investigation
Contract Research Organization (CRO)
A person who assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor
Institutional Review Board (IRB)
Any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and conduct periodic review of, biomedical research involving human subjects
Sponsor-Investigator (SI)
An individual who both initiates and actually conducts, alone or with others, an investigation, and under whose immediate direction the investigational product is administered, dispensed, or used. The obligations include both those of a sponsor and an investigator.
Significant risk device
An investigational device that: (1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; (3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or (4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
Investigational device
means a device, including a transitional device, which is the object of an investigation.
Investigation
means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device.
Termination
means discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion.
Transitional device
means a device subject to section 520(l) of the act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976.
Unanticipated adverse device effect
means any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
Code of Federal Regulations - Title 21 - Food and Drugs
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Each title (or volume) of the CFR is revised once each calendar year. A revised Title 21 is issued on approximately April 1st of each year and is usually available here several months later.
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