An observation is said to be censored in time when the event of interest cannot be observed at the time at which the analysis isconducted.

The evaluation of the likelihood that a medicine was the causative agent of an observed adverse event in a specific individual. Causality assessment is usually

A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.Source:

A person who helps a patient with daily activities, healthcare, or other activities that the patient is unable to perform because of age, illness or

A study that evaluates the association of specific genetic variants with outcomes or traits of interest, selecting the variants to be tested according to explicit

The causal relationship between an AE and a suspected drug can be, according to the WHO: certain– sufficient information provided to determine that no other reasonable explanation exists,

“Critical Terms” in WHOART refer to or might indicate serious disease states and warrant special attention.

Refers to all clinical trials being conducted with the same investigational drug.

The CIOMS is a body set up under WHO and UNESCO. It has developed the following pharmacovigilance guidelines:

All safety information contained in the core data sheet prepared by the medicinal product MAH and which the MAH requires to be listed in all

Method for assigning probability to the likelihood of a causal relationship between an AE and a suspected drug; according to established algorithms.

Individual reports of the experience of single patients, or patients managed as group. At minimum, an adverse event case report must have a reporter, product,

A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by

Improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations, or steps taken to mitigate the results of a non-conformity.

A clinical study that includes a comparison (control) group. The comparison group receives a placebo, another treatment, or no treatment at all. Source: NCI

The control or “standard” treatment is compared against the investigational treatment. It is there to show that an approved treatment in the trial works, and

A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. Source: ICH E6

1. A product comprising two or more individual products. 2. Two or more separate products packaged together in a single package or as a unit.

ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health.

A submission filed with the Medicines & Healthcare Products Regulatory Agency or EMEA as necessary to commence human clinical trials of a drug in conformance

A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations,

A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: interventional

A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. NOTE:

Core Data Sheet is an unofficial working document prepared by marketing authorization holders typically containing material relating to safety, indications, dosing, pharmacology, and other information

A finite set of standardized terms.

In the EU, other countries that review the Application during or after the Reference Member State review.

[FDA] A written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in an application or abbreviated

A medicine’s regulatory authority in the European Union. Source: EMA Glossary

The Common Technical Document (CTD) is a format for marketing applications submitted to ICH participating regions, controlling the organization of information in an application.

“The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency’s (EMA) committee responsible for human medicines. The CHMP plays a vital

“Activities to be performed by or on behalf of a Party or its Affiliates as a condition or in connection with receipt of Regulatory Approval

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and

See Manufacturing Supplement. [FDA] a supplement to an approved application which includes a change(s) to the manufacturing process, including product testing or changes to the

“In the EU, individual member states review and approve individual applications to run clinical trials within that country. One application is submitted for each clinical

The Clinical Data Interchange Standards Consortium is a standards developing organization dealing with medical research data linked with healthcare, to “enable information system interoperability to

That part of pharmaceutical development that deals with the nature of the drug substance and drug product, the manner in which both are made, and

Chemical Abstracts Service (CAS) Number: A unique accession number assigned by the Chemical Abstracts Service, a division of the American Chemical Society. Other than being

A checksum is a sequence of numbers and letters used to check data for errors. If the checksum of an original file is known, an

Certificate of Suitability to the monographs of the European Pharmacopoeia. A certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with

Another term for Centralised Procedure (CP). “An EU Procedure type in which the EMA (European Medicines Agency) reviews and approves the application on behalf of

“An EU Procedure type in which the EMA (European Medicines Agency) reviews and approves the application on behalf of all European Union countries.Certain drugs, such

The Center for Drugs Evaluation and Research (CDER) is the division of FDA that is responsible for the licensing and regulation of pharmaceuticals (with the

FDA Division that assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Source:

The Center for Biologics Evaluation and Research (CBER) is the division of FDA that is responsible for the licensing and regulation of biologic drug products.

Authorisation in the European Economic Area (EEA) for the marketing and sale of devices, and specifically within Life Sciences, Medical Devices.