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|Unexpected Adverse Drug Reaction||An adverse reaction, the nature of severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product)|
|Vulnerable Subjects||Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, or benefits associated with participation, or of retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or improvised persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.|
|Washout Period||period in a clinical study during which subjects receive no treatment for the indication under study and the effects of a previous treatment are eliminated (or assumed to be eliminated).|
|Well-being (of the trial subjects)||The physical and mental integrity of the subjects participating in a clinical trial.|