We use cookies on our site to analyze traffic, enhance your experience, and provide you with tailored content.

For more information visit our privacy policy.

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.
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.

Examples of AE in a sentence

  • The limited set of AE reported to the DCC via the REDCap database is according to guidelines in 6.3a below.

  • For clarity, “material changes” to the Protocol include, (i) the dose and dosing regimen for the Novartis Compound, Letrozole or any Combination, (ii) exclusion criteria or inclusion criteria and other safety measures (including AE management guidelines) applicable to the Novartis Compound, Letrozole or any Combination, and (iii) changes that may impact the quantities of Novartis Compound or Letrozole to be supplied hereunder.

  • If we receive a transaction or refund for processing in a currency other than Singapore Dollars (“Foreign Charge”), our currency conversion affiliate, AE Exposure Management Limited (“AEEML”) will convert it into US Dollars first (unless it was submitted to us in US Dollars) and convert it from US Dollars into Singapore Dollars.

  • If District uses or re-uses the Construction Documents on any project other than this Project, it shall remove the A/E’s seal from the Construction Documents and hold harmless Design-Build Entity, A/E, and their officers, directors, agents and employees from claims arising out of the use or re-use of the Construction Documents on such other project.

  • The DSMB receives quarterly reports, developed by the DCC and SCC, which includes aggregate reports of AE, SAE, UP, and PD, including the safety lab data according to Limited Reporting of AE (6.3) presented grouped by study arm and study site (as necessary).


More Definitions of AE

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 Actual Emissions.
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 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 an Architect, Engineer, or entity lawfully entitled to practice architecture or engineering, representing Owner within the limits of its delegated authority.