Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function

All untoward and unintended responses to an investigational medicinal product related to any dose administered;

Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.

The affirmative decision of the Research Ethics Committee (REC) that the clinical trial has been reviewed and may be conducted within the constraints set forth by the REC, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.

A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

A declaration of confirmation by the auditor that an audit has taken place.

A written evaluation by the sponsor's auditor of the results of the audit.

Documentation that allows reconstruction of the course of events.

1) Beneficence refers to the ethical obligation to maximize benefits and to minimize harms. 2) Literally, ‘doing good’. Physicians are expected to act in the best interests of their patients.

Which refers to the magnitude of a good outcome.

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).

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.

Clinical equipoise means a genuine uncertainty on the part of the expert medical community about the comparative therapeutic merits of each arm of a clinical trial. The tenet of clinical equipoise provides a clear moral foundation to the requirement that the health care of subjects not be disadvantaged by research participation.

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy.

This includes clinical trials carried out in either one site or multiple sites, whether in one or more than one Member State.

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, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports).

A community is a group of people understood as having a certain identity due to the sharing of common interests or to a shared proximity. A community may be identified as a group of people living in the same village, town, or country and, thus, sharing geographical proximity. A community may be otherwise identified as a group of people sharing a common set of values, a common set of interests, or a common disease.

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

Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities.

Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.

Principle according to which personal information can only be disclosed with the informed consent of the person concerned and solely to authorized persons.

1) "Set of conditions in which professional judgment concerning a primary interest tends to be unduly influenced by a secondary interest."D.F. Thompson, "Understanding financial conflicts of interest" (1993) 329 New England Journal of Medicine 573-6, 2) A conflict of interest arises when a member (or members) of the EC holds interests with respect to specific applications for review that may jeopardize his/her (their) ability to provide a free and independent evaluation of the research focused on the protection of the research participants. Conflicts of interests may arise when an EC member has financial, material, institutional, or social ties to the research.

A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.

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.

A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.

An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicentre trial.