Category: I

Investigator’s Brochure

A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.

Read More »


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:

Read More »

Investigational Drug

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

Read More »

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:

Read More »


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)

Read More »

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

Read More »

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

Read More »

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

Read More »

Inclusion Criteria

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

Read More »

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

Read More »


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

Read More »


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

Read More »

Register to access to our exclusive library!

Highlight Post

Recent Posts