Sweden - Provisions and Guidelines

a response to a medicinal product which is noxious and unintended and which occurs at doses which are normally used for prophylaxis, diagnosis, therapy of diseases or for modification of physiological function; for medicinal products which do not have marketing authorization, adverse reaction means all noxious and unintended responses to a medicinal product related to any dose; the phrase responses to a medicinal product means that a causal link between a medicinal product and an adverse event may be suspected,

adverse event

any untoward medical occurrence in a trial subject or patient administered a medicinal product whether it is related to these medicinal product in question or not,

audit

a systematic and independent check to clarify firstly whether the trial is carried out in accordance with the trial protocol, sponsor's SOP, GCP and applicable stipulations and secondly whether the trial report correctly reflects procedures carried out and data collected,

blinding

a procedure in which one or more participants in a trial do not know which treatment is being given; single blinding means that the patients or the investigator do not know the treatment, double blinding that the patients, the investigator, monitor and sometimes also the person analysing data from the trial do not know the treatment,

certain medicinal products for external use

what are known as free medicinal products defined in accordance with the previously applicable Medicinal Products Ordinance (1962:701) containing medicinal products for external use for the treatment of simpler pathological conditions in humans or animals where the active ingredient or ingredients have a well established medicinal use with a recognised effect and an acceptable safety margin.

clinical trial of medicinal products

any systematic study of the effect of medicinal products on humans, both patients and volunteer subjects, with the purpose of discovering or confirming the efficacy of the medicinal product and/or of identifying any side-effects and/or studying its absorption, distribution, metabolism and excretion so that the efficacy and safety of the product can be guaranteed,

coordinator

the responsible investigator or other competent person who has responsibility for the activity at the various centres taking part in a multi-centre trial being performed in a uniform manner,

CRF (Case Report Forms)

a form for recording data from a patient,

CRO (Contract Research Organisation)