Value through Innovation27 July 2016

Find out more about key terms in connection with Clinical Trials in our Glossary.

If you are looking for some other information not listed in the glossary, please contact us!

  • Adverse Drug Reaction (ADR)

    In the preapproval 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.

  • ADR (Regarding Marketed Medicinal Products)

    A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.

  • Adverse Event (AE)

    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable 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.

  • Amendment (to the protocol)

    A written description of a change(s) to or formal clarification of a protocol.

  • Applicable Regulatory Requirement(s)

    Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products of the jurisdiction where trial is conducted.

  • Approval (in relation to Independent Ethics Committees (IECs) / Institutional Review Boards (IRBs)

    The affirmative decision of the IEC / IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IEC / IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements.

  • Audit

    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 and ethical requirement(s).

  • Baseline-controlled studies

    In so-called baseline-controlled studies, the patient's state over time is compared with their baseline state. Although these studies are sometimes thought to use "the patient as his own control", they do not in fact have an internal control. Rather, changes from baseline are compared with an estimate of what would have happened to the patients in the absence of treatment with the test drug.

  • Blinding / Masking / Open-label

    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). In an open-label trial the identity of treatment is known to all.