Common use of Reporting of Serious Adverse Events Clause in Contracts

Reporting of Serious Adverse Events. All SAEs (as defined below) regardless of treatment group or suspected relationship to IMP must be reported immediately (within 24 hours of the investigator’s knowledge of the event) to the pharmacovigilance contact specified at the beginning of this protocol. If the immediate report is submitted by telephone, this must be followed by detailed written reports using the SAE report form. An SAE is any AE that: 1) Results in death 2) Is life threatening, that is any event that places the subject at immediate risk of death from the event as it occurred. It does not include an event that, had it occurred in a more severe form, might have caused death 3) Results in in-patient hospitalisation or prolongation of existing hospitalisation, excluding admission for social or administrative reasons (see further) 4) Results in a persistent or significant disability/incapacity, where disability is a substantial disruption of a person’s ability to conduct normal life functions 5) Results in congenital anomaly/birth defect in the offspring of a subject who received the IMP 6) Is an important medical event that may not result in death, be life threatening, or require hospitalisation when, based upon appropriate medical judgement, may jeopardise the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in in-patient hospitalisation, or the development of drug dependency or drug abuse. In addition to the above criteria, any additional AE that the sponsor or an investigator considers serious should be immediately reported to the sponsor and included in the corporate SAEs database system. • Hospitalisation is defined as any in-patient admission (even if less than 24 hours). For chronic or long-term in-patients, in-patient admission also includes transfer within the hospital to an acute/intensive care in-patient unit • Prolongation of hospitalisation is defined as any extension of an in-patient hospitalisation beyond the stay anticipated/required in relation to the original reason for the initial admission, as determined by the investigator or treating physician. For protocol-specified hospitalisation in clinical studies, prolongation is defined as any extension beyond the length of stay described in the protocol. Prolongation in the absence of a precipitating, treatment emergent, clinical AE (i.e. not associated with the development of a new AE or worsening of a pre-existing condition) may meet criteria for “seriousness” but is not an adverse experience and thus is not subject to immediate reporting to the sponsor • Preplanned or elective treatments/surgical procedures should be noted in the subject’s screening documentation. Hospitalisation for a preplanned or elective treatment/surgical procedure should not be reported as an SAE unless there are complications or sequelae which meet the criteria for seriousness described above. Any SAE must be reported immediately (within 24 hours), independent of the circumstances or suspected cause, if it occurs or comes to the attention of the investigator at any time during the study period. Any AE/SAE with a suspected causal relationship to IMP administration occurring at any other time after completion of the study must be promptly reported. The following information is the minimum that must be provided to the sponsor pharmacovigilance contact within 24 hours for each SAE: • Study number • Site number • Subject number • AE • Investigator’s name and contact details. The additional information included in the SAE form must be provided to the sponsor or representative as soon as it is available. The investigator should always provide an assessment of causality for each event reported to the sponsor. Upon receipt of the initial report, the sponsor will ask for the investigator’s causality assessment if it was not provided with the initial report. The investigator should report a diagnosis or a syndrome rather than individual signs or symptoms. The investigator should also try to separate a primary AE considered as the foremost untoward medical occurrence from secondary AEs which occurred as complications.

Reporting of Serious Adverse Events. All SAEs (as defined below) regardless of treatment group or suspected relationship to IMP must be reported immediately (within withiu 24 hours of the investigator’s knowledge iuvestigator's kuowledge of the eventeveut) to the pharmacovigilance contact specified at the beginning of this protocol. If the immediate report is submitted by telephone, this must be followed by detailed written reports using the SAE report form. An SAE is any AE that: (1) Results in death (2) Is life threatening, that is any event that places the subject at immediate risk of death from the event as it occurred. It does not include an event that, had it occurred in a more severe form, might have caused death (3) Results in in-patient hospitalisation or prolongation of existing hospitalisation, excluding admission for social or administrative reasons (see further) (4) Results in a persistent or significant disability/incapacity, where disability is a substantial disruption of a person’s 's ability to conduct normal life functions (5) Results in congenital anomaly/birth defect in the offspring of a subject who received the IMP (6) Is an important medical event that may not result in death, be life threatening, or require hospitalisation when, based upon appropriate medical judgement, may jeopardise the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in in-patient hospitalisation, or the development of drug dependency or drug abuse. In addition to the above criteria, any additional AE that the sponsor or an investigator considers serious should be immediately reported to the sponsor and included in the corporate SAEs database system. • Hospitalisation is defined as any in-patient admission (even if less than 24 hours). For chronic or long-long term in-patients, in-patient admission also includes transfer within the hospital to an acute/intensive care in-patient unit • Prolongation of hospitalisation is defined as any extension of an in-patient hospitalisation beyond the stay anticipated/required in relation to the original reason for the initial admission, as determined by the investigator or treating physician. For protocol-specified hospitalisation in clinical studies, prolongation is defined as any extension beyond the length of stay described in the protocol. Prolongation in the absence of a precipitating, treatment emergent, clinical AE (i.e. not associated with the development of a new AE or worsening of a pre-existing condition) may meet criteria for “seriousness” but is not an adverse experience and thus is not subject to immediate reporting to the sponsor • Preplanned Preplauued or elective treatmentstreatmeuts/surgical procedures should be noted in uoted iu the subject’s 's screening documentation. Hospitalisation for a preplanned or elective treatment/surgical procedure should not be reported as an SAE unless there are complications or sequelae which meet the criteria for seriousness described above. Any SAE must be reported immediately (within 24 hours), independent of the circumstances or suspected cause, if it occurs or comes to the attention of the investigator at any time during the study period. Any AE/SAE with a suspected causal relationship to IMP administration occurring at any other time after completion of the study must be promptly reported. The following information is the minimum that must be provided to the sponsor pharmacovigilance contact within 24 hours for each SAE: • Study number • Site number • Subject number • AE • Investigator’s 's name and contact details. The additional information included in the SAE form must be provided to the sponsor or representative as soon as it is available. The investigator should always provide an assessment of causality for each event reported to the sponsor. Upon receipt of the initial report, the sponsor will ask for the investigator’s 's causality assessment if it was not provided with the initial report. The investigator should report a diagnosis or a syndrome rather than individual signs or symptoms. The investigator should also try to separate a primary AE considered as the foremost untoward medical occurrence from secondary AEs which occurred as complications.