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The eCTD has five modules: Administrative information and prescribing information. Common technical document summaries. Quality. Nonclinical study reports. 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)
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 ...
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.
A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.
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Used to rapidly make millions to billions of copies (complete copies or partial copies) of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it (or a part of it) to a large enough amount to study in detail: Genetics, Molecular biology: Somatic cell nuclear transfer