Recording of Adverse Events. Adverse Events are illnesses or signs/symptoms that appear or worsen during the testing of a drug whether or not considered related to the investigational product (synonyms = medicinal or pharmaceutical product, study drug, clinical trial materials, etc.), including side effects, injury, toxicity, or hypersensitivity reactions. All adverse events, including observed, elicited, or volunteered problems, complaints or symptoms, are to be recorded on the Adverse Events page in the subject’s Case Report Form. The need to capture this information is not dependent upon whether adverse events are associated with use of the investigational product. Adverse events resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent medications progression of disease states should also be recorded. In order to avoid vague, ambiguous or colloquial expressions, adverse events should be recorded in standard medical terminology rather than the subject's own words. Signs and symptoms should be reported individually unless, in the judgment of the investigator, they can be grouped under an inclusive term (e.g., gastroenteritis in lieu of abdominal pain, nausea, vomiting, and diarrhea). Each adverse event is to be evaluated for date/time of onset, duration, intensity, and causal relationship with the investigational product or other factors. At every study visit, the investigator must document new AEs and the outcome of ongoing AEs. Any subject with an AE (including SAEs) or any clinically significant abnormal laboratory result or physical finding reported as an AE will be followed by the investigator until the AE resolves, resolves with sequalae, is otherwise explained by a medical condition, follow-up is not possible (document), or the subject dies.
Recording of Adverse Events. Any AE should be recorded on the Adverse Events form in the CRF and source documents. In order to avoid vague, ambiguous or colloquial expressions, the AE should be recorded in standard medical terminology rather than the subject’s own words. Whenever possible, the Investigator should group together into a single term signs and symptoms which constitute a single diagnosis. The existence of or change in an AE may be concluded due to the necessity to administer a concomitant medication, from a spontaneous report of the subject, from the physical examination or from special tests like ECG, EEGs, laboratory assessments or other study specified tests (source of AE). For each subject that has signed the informed consent and prior to study drug allocation at any dose, any change to medical status should be recorded in patient’s medical file in accordance to local requirements and the medical history CRF only. Any change to medical status, which occurs after study drug allocation at any dose in the specified study AE collection period will be handled as an (S)AE. For each subject that has signed the informed consent but does not qualify for allocation to treatment, i.e. Screen Failure, any change to medical status (from the time of ICF signature until determination of non-qualification for the study) should be recorded in patient’s medical file according to local requirements. The related medical status change information will not be reviewed by Xxxxxx or delegated staff, and will not qualify as a study (S)AE. Each AE, of the treatment arm as well as the no treatment arm, is to be evaluated for duration, severity, seriousness and causal relationship to the investigational drug. The action taken with study drug, the concomitant treatment/therapy introduced and the outcome as well as whether the event led to study termination will also be recorded. The post-study AE collection period is defined as 30 days after the subject’s termination of study drug (collection of (S)AEs should be passive in this period unless otherwise specified). Severity The severity of the AE should be characterized as “mild, moderate or severe” according to the following definitions: - Mild events are usually transient and do not interfere with the subject’s daily activities. - Moderate events introduce a low level of inconvenience or concern to the subject and may interfere with daily activities. - Severe events interrupt the subject’s usual daily activity. Drug-Event Relationship The causal ...
Recording of Adverse Events. All AEs that begin or worsen after the patient has provided informed consent will be recorded. Those AEs that occur prior to study dosing, can be captured in the patient’s baseline conditions, however if any of these AEs are considered, serious, these are to be reported both to Pharmacovigilance and documented in the eCRF AE log. For events that are considered by the Investigator to be related to the study drug, the monitoring of the AE should be continued through the end of the study, for at least 30 days following last dose of study drug (if the end of the study is within 30 days of the last dose of study drug), or until the AE has resolved. Investigators should use medical judgment in determining whether a particular symptom or sign is considered to be a part of COVID-19 infection clinical course or not and report them or not as AEs according to such determination. When a clear determination cannot be made by the investigators, a sign or symptom should be reported as AEs. All deaths irrespective of cause of death including due to COVID-19 during the study should be reported to the Sponsor using an SAE form. Adverse events (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible, rather than individual underlying signs and symptoms. When a clear diagnosis cannot be identified, each sign or symptom should be recorded as a separate AE. The Investigator should ask the patient non-leading questions to determine if any AEs have occurred during the study, since the last study visit. Adverse events may also be recorded when they are volunteered by the patient, or through physical examination, laboratory tests, or other clinical assessments. An AE should be followed until its resolution or until it is judged to be permanent, and assessment should be made at each visit (or more frequently, if necessary) of any changes in severity of the event, the suspected relationship to the study treatment, the interventions required to treat the event, and the outcome.
