Search results
Results from the WOW.Com Content Network
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.
An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: Dose (of the study drug) Frequency of dosing interval; Methods of administration; Safety monitoring ...
May also contain results of various clinical trials (studies) and/or explanations of the medication's effect on various populations (e.g. children, women, etc.). Indications and Usage - uses (indications) for which the drug has been FDA-approved (e.g. migraines, seizures, high blood pressure).
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.
This template is intended for external links. It is not designed for use as a citation template for reliable sources. It should be used in conformance with the external links guideline and with the relevant section of the Manual of Style. Do not use this template to advertise clinical trials to patients.
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]
The Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)