A printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each study subject
Clinical Study/Clinical Trial
Any investigation in humans 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 and investigational product(s) with the object of ascertaining its efficacy. . The terms “clinical trial” and “clinical study” are synonymous and can be used interchangeably although Clinical Study is the preferred AstraZeneca designation.
Clinical Trial Application (CTA)
Before initiating a clinical study in a Member State (MS) of the European Union (EU), a positive opinion must be given by the Competent Authority of that MS to the Clinical Trial Application (CTA) submitted in support of the study. The CTA documentation will provide medical and scientific justification for the proposed clinical study. The CA has a maximum period of 60 days to respond to the applicant. Note that approval for the study must also be given by an Independent Ethics Committee (IEC) in that MS.
Clinical Trial Material
The testing material used in a clinical study, including the primary study drug, comparator drugs, and placebo as specified in the study protocol. Clinical study material includes any investigational product, including medical devices, designed for human use.
Clinical Trial Notification (CTN)
The CTN is the Japanese equivalent of the IND process in US and the CTA in the EU. Review timelines range between 30 and 15 days depending upon the stage of development and chemical form of the drug concerned. Note that approval for the study must also be given by an Institutional Review Board (IRB) in Japan
A study in which a participant is randomly (not necessarily) assigned to one of two or more treatment groups for purposes of comparing the results of the separate treatment groups.
An investigational or marketed drug (i.e., active control) or placebo used as a reference in a clinical study.
For the purposes of defining the clock start date for posting results, a study is considered completed when the final patient or healthy volunteer was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the study concluded according to the pre-specified protocol or was terminated.
Prevention of disclosure, to other than authorised individuals, of a sponsors proprietary information or a subject’s identity.