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Safety and Tolerability: The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests, vital signs, clinical adverse events and other special safety tests. The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject.
Screening: Evaluation of a patient's qualifications for participation in a clinical trial.
Screening Study: A type of clinical trial that studies ways to detect an illness earlier or to determine if a person is at risk for disease.
Side Effects (Adverse Event; AE): Any untoward medical occurrence in a patient or clinical investigational subject administered an investigational drug and which does not necessarily have to have a causal relationship with this treatment. A Side Effect can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease;temporarily associated with the use of an investigational drug, whether or not related to the investigational drug.
Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.
Study Doctor: see Investigator
Study Phase: see Phase 1, Phase 2, Phase 3, and Phase 4
Study Team (ResearchTeam): A multi-disciplinary group of qualified individuals responsible for the management of a clinical trial.
Subject/Trial Subject/Research Subject: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
Treatment Study: A type of clinical trial that determines if a drug is safe and effective.
Trial Site/Clinical Site: The location(s) where trial-related activities are actually conducted.
None at this time.
None at this time.
Witness: A person who is present when the subject or patient gives consent to participate in the clinical trial.
None at this time.
None at this time.
None at this time.
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