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Triamcinolone acetonide, sold under the brand name Kenalog among others, is a synthetic corticosteroid medication used topically to treat various skin conditions, [13] to relieve the discomfort of mouth sores, and by injection into joints to treat various joint conditions.
The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. Case report forms contain data obtained during the patient's participation in the clinical trial.
Triamcinolone is used to treat various medical conditions, such as eczema, alopecia areata, lichen sclerosus, psoriasis, arthritis, allergies, ulcerative colitis, lupus, sympathetic ophthalmia, temporal arteritis, uveitis, ocular inflammation, keloids, urushiol-induced contact dermatitis, aphthous ulcers (usually as triamcinolone acetonide), central retinal vein occlusion, visualization during ...
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Clinical trials are medical research studies conducted on human subjects. [1] The human subjects are assigned to one or more interventions, and the investigators evaluate the effects of those interventions. [1] [2] The progress and results of clinical trials are analyzed statistically. [3] [4]
A source document is a document in which data collected for a clinical trial is first recorded. This data is usually later entered in the case report form.The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH-GCP) guidelines define source documents as "original documents, data, and records."
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Subject/Trial Subject An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. (ICH E6) Superiority trial A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control). (ICH E9)