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2. Investigator's brochure - Wikipedia

   en.wikipedia.org/wiki/Investigator's_brochure

   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 ...

3. Electronic common technical document - Wikipedia

   en.wikipedia.org/wiki/Electronic_Common...

   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.

4. Contract research organization - Wikipedia

   en.wikipedia.org/wiki/Contract_research_organization

   The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...

5. Common Technical Document - Wikipedia

   en.wikipedia.org/wiki/Common_Technical_Document

   Clinical – efficacy and safety (clinical trials) 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.

6. New Drug Application - Wikipedia

   en.wikipedia.org/wiki/New_Drug_Application

   Some two-thirds of candidate drugs fail in Phase 2 clinical trials due to the drug not being as effective as anticipated. Phase 3: The drug is typically tested in several hundred to several thousand people with the targeted disease in double-blind, placebo controlled trials to demonstrate its specific efficacy. Under 30% of drug candidates ...

7. Phases of clinical research - Wikipedia

   en.wikipedia.org/wiki/Phases_of_clinical_research

   Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. [1] When expressed specifically, a clinical trial phase is capitalized both in name and Roman numeral, such as "Phase I" clinical trial. [1]

8. Clinical trial - Wikipedia

   en.wikipedia.org/wiki/Clinical_trial

   A clinical trial participant receives an injection. Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further ...

9. Electronic trial master file - Wikipedia

   en.wikipedia.org/wiki/Electronic_trial_master_file

   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.