The act of determining if an individual meets minimum requirements to become part of a pool of potential candidates for participation in a clinical trial. Screening may involve invasive or diagnostic procedures and/or tests (for example, diagnostic psychological tests, x-rays, blood draws). For this type of screening, informed consent for these screening procedures and/or tests shall be obtained; this consent may be separate from obtaining consent for the study.
The act of obtaining informed consent for participation in a clinical trial from subjects deemed eligible or potentially eligible to participate in the clinical trial. Subjects entered into a trial are those who sign the informed consent document directly or through their legally acceptable representatives.
The act of assigning a registration number to the subject indicating that the principal investigator has verified that the subject meets all of the inclusion criteria and none of the exclusion criteria.
The act of assigning a subject to a treatment. Subjects who are enrolled in the trial are those who have been assigned to a treatment.
An individual who is or becomes a participant in clinical research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
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