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Glossary- Clinical Trials Terminology – Q to S
quality assurance (QA) All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s)
quality control (QC) The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trialrelated activities have been fulfilled
random allocation Assignment of subjects to treatment (or control) groups in an unpredictable way. Assignment sequences are concealed, but available for disclosure in the event a subject has an adverse experience
randomization The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias
raw data Records of original observations, measurements, and activities (such as laboratory notes, evaluations, data recorded by automated instruments) without conclusions or interpretations
recruitment (subjects) Process used by investigators to enroll appropriate subjects into a clinical study, i.e., those selected on the basis of the protocol’s inclusion and exclusion criteria.
recruitment period Time period during which investigators must complete enrollment of their quota of subjects for a trial.
recruitment target Number of subjects that must be recruited into a study to meet the requirements of the study protocol. In multicenter studies, each investigator has a recruitment target.
regulatory authorities 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. These
bodies are sometimes referred to as competent authorities
risk In clinical trials, the probability of harm or discomfort for subjects. Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat, for example, will be expected to have a low incidence of side effects. However, unpleasant side effects may be an acceptable risk when testing a promising treatment for a life-threatening illness.
safety Relative freedom from harm; in clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests and procedures, psychiatric evaluation, and/or physical examination of subjects
serious adverse event (SAE) or serious adverse drug reaction (serious ADR) Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
single-blind study One in which subjects do not know whether they are receiving the active drug or a placebo.
source data All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies)
source documents Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).
sponsor An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
statistical significance State that applies when a hypothesis is rejected. Whether or not a given result is significant depends on the significance level adopted. For example, one may say “significant at the 5% level.”
This implies that a level of significance has been applied such that when the null hypothesis is true there is only a 1 in 20 chance of rejecting it and/or that the observed result has led to rejection of the null hypothesis.
subject/trial subject An individual who participates in a clinical trial, either as recipient of the investigational product(s) or as a control