Screen Failures. Screen failures are defined as patients who consent to participate in the clinical study but are not subsequently entered in the study. The Investigator must maintain a log of screen failure patients that includes, at a minimum, demography, screen failure details, eligibility criteria, and any serious adverse events (SAEs) occurring after providing informed consent. If the patient is unable to receive study medication within 60 days of screening, the patient may be rescreened once. See details for rescreening in Section 8.1.
Appears in 1 contract
Sources: Investigator's Agreement
Screen Failures. Screen failures are defined as patients who consent to participate in the clinical study but are not subsequently entered randomized for treatment in the study. The Investigator must maintain a log of screen failure Minimal information is required for these patients that includes, at a minimum, demographyincluding demographics, screen failure details, eligibility criteria, and any serious adverse events event (SAEsSAE) occurring after providing informed consentnot related to COVID-19. If Individuals who do not meet the patient is unable to receive criteria for participation in this study medication within 60 days of screening, the patient (screen failure) may be rescreened oncerescreened. See details Rescreened patients should be assigned the same patient number as for rescreening in Section 8.1the initial screening.
Appears in 1 contract
Sources: Investigator Agreement
Screen Failures. Screen failures are defined as patients participants who consent to participate in the clinical study but are not subsequently entered in the studyassigned to study intervention. The Investigator must maintain a log A minimal set of screen failure patients that includesinformation will be collected, at a minimum, including demography, screen failure details, eligibility criteria, and any serious adverse events SAE. Individuals who do not meet the criteria for participation in this study (SAEsscreen failure) occurring after providing informed consent. If the patient is unable to receive study medication within 60 days of screening, the patient may be rescreened oncerescreened. See details for rescreening in Section 8.1Rescreened participants should be assigned a new participant number.
Appears in 1 contract
Sources: Investigator's Agreement