AE definition

AE means any untoward medical occurrence in a Human Subject administered Test Article. An AE does not necessarily have a causal relationship with the Test Article, that is, it can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the Test Article, whether or not it is related to it. See FDA Good Clinical Practice Guideline (International Conference on Harmonisation (ICH) E6: “Good Clinical Practice: Consolidated Guidance, 62 Federal Register 25, 691 (1997)).
AE has the meaning set forth in 21 C.F.R. § 312.32 and generally means any untoward medical occurrence associated with the use of a product in human subjects, whether or not considered related to such product. An AE does not necessarily have a causal relationship with a product, that is, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of such product.

Examples of AE in a sentence

  • As required by the Agreement, and as properly authorized, provide the following categories of services: provide constructability review comments on documents produced by the A/E during the Schematic Design, Design Development, and Construction Document stages; develop and maintain estimates of probable construction cost, value engineering, project schedules, and construction schedules; lead and manage the Subcontractor Prequalification and Bidding process, Construction and Closeout Stage.

  • The Transmission Provider shall redispatch Resources in accordance with the Energy and Operating Reserve Markets operations specified in Attachment AE.

  • Identify the presence and nature (e.g., zone A, zone AE, zone AE with floodway) of any FEMA mapped floodplains; including the panel number.

  • The Network Customer is responsible for providing its Resource and load information to the Transmission Provider in accordance with Attachment AE.

  • Preconstruction Services: The CM will work cooperatively with the Contracting Authority/Owner, A/E, and Project Team, and will provide, among other services, schedule development, estimate development, Guaranteed Maximum Price (GMP) proposal, subcontractor prequalification and bidding, constructability review, permits, budgeting, value engineering, and preconstruction planning throughout the preconstruction stages.


More Definitions of AE

AE shall have the same meaning as in the ICH guidelines (E2A, E2C and E2D) relating to the collection, maintenance analysis and reporting of an adverse event or experience.
AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, as defined under 21 C.F.R § 312.32. See also FDA Good Clinical Practice Guideline (International Conference on Harmonisation (ICH) E6: “Good Clinical Practice: Consolidated Guidance, 62 Federal Register 25, 691 (1997)).
AE means an Architect, Engineer, or entity lawfully entitled to practice architecture or engineering, representing Owner within the limits of its delegated authority.
AE means Actual Emissions.
AE means any untoward medical occurrence associated with the use of a Test Article in humans, whether or not considered related to the Test Article (21 C.F.R §§ 312.32, 308.3; see also FDA Good Clinical Practice Guideline, International Conference on Harmonisation (ICH) E6: “Good Clinical Practice: Consolidated Guidance, 62 Federal Register 25,691 (1997)).
AE means any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.