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Clinical study reports; A full table of contents could be quite large. There are two categories of modules: Regional module: 1 (different for each region; i.e., country) Common modules: 2–5 (common to all the regions) The CTD defines the content only of the common modules.
Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements.
A medical writer, also referred to as medical communicator, [1] is a person who applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe research results, product use, and other medical information. The medical writer develops any of the five modules of the Common Technical ...
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 ...
Clinical trial – an experiment with human subjects to assess safety and efficacy of drugs Academic clinical trials – clinical trials run at academic centers (e.g., medical schools, academic hospitals, and universities) Clinical trials unit – biomedical research units dedicated to conducting clinical trials
Clinical study design; Clinical study report; Clinical trial; Clinical trial management system; Clinical trial portal; Clinical trial registration; Clinical trials publication; Clinical trials unit; Cluster-randomised controlled trial; Code-break procedure; Cohen's h; Common Technical Document; Common Terminology Criteria for Adverse Events ...
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A variant of the tool (KID-SCID) was developed at York University for generating childhood DSM-IV diagnoses for clinical research studies. [17] In 2015 a study evaluated the psychometric properties of the KID-SCID in a Dutch sample of children and adolescents [18] which later led to the creation of SCID-5-Junior for the DSM-5 (see below).