The date of the first marketing authorisation for any product containing the active substance granted to any company in any country in the world.

Definition according to GVP Annex I (Rev 3): An identified risk or potential risk that could have an impact on the risk-benefit balance of the

Definition according to GVP Annex I (Rev 3):An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest.

Non-profit consortium formed between the US FDA, industry, academia and the Wellcome Trust to identify genetic variants associated with SAEs.

The rate of new cases of an outcome occurring per number of known at risk or exposed; and is a measurement of risk.

MedDRA includes a term list of important medical events (available on the EMA website), which aims to facilitate the classification of suspected ADRs, data analysis and the assessment of ICSRs.

International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals.

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator. Source: Clinicaltrials.gov

A site at which clinical research is conducted, usually associated with a hospital or university.

See Investigational Drug

A request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product

The drug being evaluated in the trial; this definition is synonymous with “investigational new drug” or “investigational medicinal product.”

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can

Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial. Source:

An IRB (also known as an independent ethics committee (IEC), ethical review board (ERB) or research ethics board (REB)) is a group of doctors, scientists,

Representative of a Health Authority performing a GCP/TMF inspection.

The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies)

The document used in the informed consent or process. [Note that there is a “model informed consent” master document and an executed informed consent that

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects

An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific members, whose responsibility it is

A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study. Source: Clinicaltrials.gov

A subset of protocol deviations that may significantly impact the completeness, accuracy, and/or reliability of the study data or that may significantly affect a subject’s

The Investigator’s Brochure is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s)

The IMP dossier (IMPD) gives information related to the quality of any IMP (i.e. including reference product and placebo), manufacture and control of the IMP,

[FDA] An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA)

The International Organization for Standardization (ISO) is a worldwide federation from some 100 countries, with one standards body representing each member country. Member organizations collaborate

International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry

For biotechnological/biological products, a material produced during a manufacturing process that is not the drug substance or the drug product but for which manufacture is

An overall analysis and summary of the safety data required by the FDA for an NDA or BLA.

[FDA] The ISE is a comprehensive integrated analysis of the effectiveness of a study drug. The purpose of the ISE is to describe the available

A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease.

Identification of Medicinal Products (IDMP) is a set of international standards that define, characterize and uniquely identify regulated pharmaceutical products during their lifecycles.

ICH guidance on the Structure and content of clinical study reports; aims to allow the compilation of a single core clinical study report acceptable to