Category: I

Important Risk

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

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Identified Risk

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.

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Incidence

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

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Important Medical Event (IME)

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.

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ICH

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

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Investigator

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

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Investigational Drug

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

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Interim Analysis

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:

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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)

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Informed consent form (ICF)

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

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Informed Consent

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

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Independent Ethics Committee

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

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Inclusion Criteria

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

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Important Protocol Deviation

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

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Indication

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

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ICH E3

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

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