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The Common Terminology Criteria for Adverse Events (CTCAE), [1] formerly called the Common Toxicity Criteria (CTC or NCI-CTC), are a set of criteria for the standardized classification of adverse events of drugs and treatment used in cancer therapy.
Download as PDF; Printable version; In other projects ... Pharmacovigilance. ... Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63 ...
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial.
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. [1]: 7 The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep ...
This publication laid the groundwork for CIOMS' 1982, 1993, 2002, 2009, and 2016 versions of International Ethical Guidelines for Health-Related Research Involving Humans. [3] These guidelines have been praised for including diverse stakeholders from low- and middle-income countries, compared to the Declaration of Helsinki written by physicians ...
Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines or devices which have received marketing authorisation or are actively being studied in clinical trials in the European Economic Area (EEA).