Property:RefPreview
From GxPlex
Auto-derived 200-character preview of this reference's content, used in Document pages' References list.
G
(l)‘inspection’: the act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, … +
U
(m) Family member means any one of the following legally competent persons: Spouse; parents; children (including adopted children); brothers, sisters,… +
(m) Significant risk device means an investigational device that:
(1) Is intended as an implant and presents a potential for serious risk to the healt… +
(m) Written, or in writing, for purposes of this part, refers to writing on a tangible medium (e.g., paper) or in an electronic format.… +
G
(m)‘adverse event’: any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessa… +
U
(n) Assent means a child's affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agr… +
(n) Sponsor means a person who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, d… +
G
(n)‘adverse reaction’: all untoward and unintended responses to an investigational medicinal product related to any dose administered;… +
U
(o) Children means persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the … +
(o) Sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose im… +
G
(o)‘serious adverse event or serious adverse reaction’: any untoward medical occurrence or effect that at any dose results in death, is life-threateni… +
U
(p) Parent means a child's biological or adoptive parent.… +
(p) Subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used… +
G
(p)‘unexpected adverse reaction’: an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.… +
U
(q) Termination means a discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion.… +
(q) Ward means a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, St… +
(r) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in a clinical investigation.… +
(r) 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 d… +
(s) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.… +
(s) Unanticipated adverse device effect means any serious adverse effect on health or safety or any lifethreatening problem or death caused by, or ass… +
