psychological stress or embarrassment. Please also include in this section any potential risks that need to be considered for the study team, such as during home visits, and how these will be mitigated. This example text represents standard definitions. Adapt the text as appropriate. In this section, specify which if any - adverse events will be reported on the CRF, and which details – will be recorded, stating any exceptions and additions to the definition of an Unanticipated Problem, AE and SAE (defined in section 9.1) appropriate to the study. The decision on the nature of adverse events to be recorded for each study will depend on the risk associated with the study and the objectives of the study. Example text: the purposes of this study the investigator is responsible for recording all Adverse “For Events, regardless of their relationship to the study, with the following exceptions: Conditions that are present at screening and do not deteriorate will not be considered adverse events. The description of each AE on the CRF will include: A description of the AE; The onset date, duration, date of resolution; Severity (mild, moderate or severe); Seriousness (i.e. is it an SAE?); Any action taken, (e.g. treatment, follow-up tests); The outcome (recovery, death, continuing, worsening); The likelihood of the relationship of the AE to the study (Unrelated, Possible, Probable, Definite). The severity and relationship of an AE will be assessed as per appendix X. The seriousness of an AE will be assessed by an investigator according to the definition in section 8.1, with the following exception: Hospitalisation due to progression of disease will not be considered an SAE for the purposes of this – Outline how Adverse Event information will be collected. Make sure the schedule and method matches the intent of the study. Example text: events will be recorded from the time the participant signs the informed “Safety consent form until 48 hours after the last study visit. At every study visit participants will be asked have you felt since your last visit?” in order to elicit any changes in their well-being.” “How – Outline the reporting requirements and timelines for reporting SAEs to the Ethics Committee and/or Regulatory Agencies. Consider a flowchart to clarify the reporting requirements. State who will be responsible for submitting SAE reports to HRECs and regulatory authorities.
psychological stress or embarrassment. Please also include in this section any potential risks that need to be considered for the study team, such as during home visits, and how these will be mitigated. This example text represents standard definitions. Adapt the text as appropriate. In this section, specify which – if any - adverse events will be reported on the CRF, and which details will be recorded, stating any exceptions and additions to the definition of an Unanticipated Problem, AE and SAE (defined in section 9.1) appropriate to the study. The decision on the nature of adverse events to be recorded for each study will depend on the risk associated with the study and the objectives of the study. Example text: “For the purposes of this study the investigator is responsible for recording all Adverse Events, regardless of their relationship to the study, with the following exceptions: Conditions that are present at screening and do not deteriorate will not be considered adverse events. The description of each AE on the CRF will include: A description of the AE; The onset date, duration, date of resolution; Severity (mild, moderate or severe); Seriousness (i.e. is it an SAE?); Any action taken, (e.g. treatment, follow-up tests); The outcome (recovery, death, continuing, worsening); The likelihood of the relationship of the AE to the study (Unrelated, Possible, Probable, Definite). The severity and relationship of an AE will be assessed as per appendix X. The seriousness of an AE will be assessed by an investigator according to the definition in section 8.1, with the following exception: Hospitalisation due to progression of disease will not be considered an SAE for the purposes of this – Outline how Adverse Event information will be collected. Make sure the schedule and method matches the intent of the study. Example text: “Safety events will be recorded from the time the participant signs the informed consent form until 48 hours after the last study visit. At every study visit participants will be asked “How have you felt since your last visit?” in order to elicit any changes in their well-being.” – Outline the reporting requirements and timelines for reporting SAEs to the Ethics Committee and/or Regulatory Agencies. Consider a flowchart to clarify the reporting requirements. State who will be responsible for submitting SAE reports to HRECs and regulatory authorities.