patients role in activities or decisions that will have consequences for the patient community, because of their specific knowledge and relevant experience as patients
A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalisable knowledge
European Patients' Academy on Therapeutic Innovation
(of research). The concurrent oversight of research on a periodic basis. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis. (see also Audit)
Any medical occurrence in a person during a clinical investigation/trial. This is not the same as "serious event," which is based on patient/event outcome.
Agentur für Gesundheit und Ernährungssicherheit, the Austrian Competent Authority (see NCA).
A type of average (measure of central tendency), which is defined as the sum of all the values in a set of numerical data divided by n; this value is usually the most common usage of the word "average," and typically it is labelled as either µ (lowercase Greek letter "mu") or m to denote a population mean or x (referred to a "x bar") to denote a sample mean(see also Mean, Geometric mean, Harmonic mean, Median, Mode)
three times a day
Research Ethics Committee or Independent Ethics Committee (IEC) or Ethics Committee - An independent body (a review board or a committee, institutional, regional, national, or supranational), whose membership comprise smedical/ scientific professionals and nonmedical/ non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations, and regulatory requirements pertaining to Independent Ethics Committees (and Research Ethics Committees) may differ among countries, but should allow such a committee to act in agreement with GCP as described in this guideline
Marketing Authorisation - A medicinal product must have a valid marketing authorisation before it can be launched onto the market and sold to consumers. Marketing authorisation for a medicinal product can be applied for through the mutual recognition procedure, centralized procedure or national procedure and is in Europe given either by the Commission for products licensed via the centralized procedure or by the National Competent Authorities for product licensed via the other procedures
Investigator's brochure - A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of investigational product(s) in human subjects
Last Updated: Tuesday, 06 October 2015 13:43 | Print
The EUPATI project receives support from the European Union (IMI JU) and EFPIA companies