Recording and Follow-up of Adverse Events Sample Clauses

Recording and Follow-up of Adverse Events. At each visit, the subject should be asked a nonleading question such as: “How have you felt since starting the new treatment/the last assessment?” All observed or volunteered AEs, regardless of treatment group or suspected causal relationship to IMP, will be recorded on the AE page(s) of the eCRF. Events involving drug reactions, accidents, illnesses with onset during the treatment phase of the study, or exacerbation of pre- existing illnesses should be recorded (see also Section 8.1.2.7 and Section 8.1.2.10). Any AEs already recorded and designated as “continuing” should be reviewed at each subsequent assessment. For all AEs, the investigator must pursue and obtain information adequate both to determine the outcome of the AE and to assess whether it meets the criteria for classification as a SAE requiring immediate notification to the sponsor or its designated representative. For all AEs, sufficient information should be obtained by the investigator to determine the causality of the AE (i.e. IMP or other illness). The investigator is required to assess causality and record that assessment on the eCRF. Follow-up of the AE, after the date of IMP discontinuation, is required if the AE or its sequelae persist. Follow-up is required until the event or its sequelae resolve or stabilise at a level acceptable to the investigator and the sponsor’s clinical monitor or his/her designated representative.