SERIOUS ADVERSE EVENT (SAE) REPORTING FORM

Transcription

1 SERIOUS ADVERSE EVENT (SAE) REPORTING FORM This form must be used when reporting local/ non-local serious adverse events (refer to attached table for details) All sections must be completed. Principal Investigator: Designation Department: Institution: IRB Registration Number: Protocol No (as per IRB Approval Form): Version No (as per IRB Approval Form): Protocol Title (as per IRB Approval Form): Person Completing Form: Date Investigator Became Aware of Adverse Event: Type of Report (Check one): [ ] Initial Report [ ]Follow-up Report Date of adverse event: Location (Check one): [ ] SHS Member Institution [ ] NON-SHS Member Institution Subject Identifier: Description of Event : (In the space below, please provide a brief description of the SAE) and subsequent treatment, if any. Additional documents describing the event may be attached (please remove all personal identifiers before submitting additional documents). Treatment administered : In the space below, please provide a brief description of the treatment, if any. Additional documents pertaining to the treatment may be attached (please remove all personal identifiers before submitting additional documents). Costs of Treatment: In the space below please indicate who paid (or was billed) for the costs of treatment, if any, of the SAE. SOP for SHS IRBs Page 9 of 14

2 Outcome of SAE at the time of this report (Check all that apply): [ ]Resolved [ ]Unresolved* [ ]Chronic condition [ ]Death [ ]Hospitalised [ ]Patient withdrawn from study *If the adverse event is unresolved (i.e. if additional treatment or follow-up of the AE is necessary). Please note that a follow-up report must be submitted when the AE resolves or has been determined to be a chronic condition. Causality (Check one): [ ] Definitely Related [ ] Probably Related [ ] Possibly Related [ ] Unlikely to be Related administration of the product is reasonable and there is no other cause to explain the event (or a rechallenge is positive) E.g. Bone Marrow Depression following administration of cytotoxic chemotherapy. administration of the product is reasonable and the event is more likely to be explained by the medicinal product than by another cause. E.g. nausea and vomiting. administration of the product is reasonable, but the event could have been due to an equally likely cause. E.g. Headache. administration of the product is unlikely but cannot be ruled out. E.g. mouth ulcer following administration of an oral drug. [ ] Not Related Where a temporal (timely) relationship of the onset of the event, relative to administration of the product is not reasonable. E.g. cut finger. Or where another cause can explain the occurrence of the event by itself E.g. headache associated with migraine. Determining Cause: The investigator must make an independent determination as to whether the SAE was thought to be related to study participation (i.e. study intervention, test article administration, study procedures). Note: Adverse events which are clearly unrelated to study activities do not need to be reported except in the case of a death. If there is a possibility that the adverse event is related to study activities, or if there might be a difference of opinion that the event was unrelated to study activities, the event should be classified as Possibly Related. SOP for SHS IRBs Page 10 of 14

3 Please explain the rationale for the determination of causality in the space below.: Classification of SAE (Check all that apply): At least one should be checked for this form to be used [ ] Any hospital admission (unless hospitalization is preplanned). [ ] Unanticipated or life-threatening drug reaction including but not limited to one that necessitates discontinuation of study participation or that results in death. [ ] Congenital anomaly occurring in the offspring of a research participant who had taken a study drug. [ ] Adverse events exceeding the nature, severity, or frequency described in the investigator s brochure or protocol. [ ] Prolongs a stay in a healthcare facility. [ ] Significant, persistent, or permanent harm or disability, either physical or psychological. [ ] Death. [ ] Medical event(s) that may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above. [ ] Any other event as defined in the study protocol. Significant New Finding: Should enrolled subjects be informed about this adverse event? If No, explain your rationale. [ ]Yes [ ]No If Yes, describe how enrolled subjects will be informed about the event, and attach a copy of any correspondence to subjects for review: Informed Consent: Please discuss whether the consent form should be modified to describe the SAE for future subjects. [ ] YES. A modified informed consent form will be submitted for IRB approval, prior to the enrollment of any new subjects. [ ] NO. There is no need for the consent form to be modified.** SOP for SHS IRBs Page 11 of 14

4 ** If your answer is NO, please explain the rationale for your decision. Notifying Other Parties: What other agencies (e.g., study sponsor, regulatory bodies, DSMB, other IRBs) have you notified about the SAE? Principal Investigator s Certification: I have thoroughly reviewed the details of this serious adverse event and the information above accurately reflects my conclusions.*** ***If the Principal Investigator is unavailable, a co-investigator, who has been designated to manage the study may sign this form. For IRB Use only Name Signature Date Date received: Date reviewed: Action taken: Date: IRB s Acknowledgement: Name Signature Date SOP for SHS IRBs Page 12 of 14

5 Principal Investigator: Designation Department: Institution: IRB Registration Number: Protocol No (as per IRB Approval Form): Version No (as per IRB Approval Form): Protocol Title (as per IRB Approval Form): Date of AE: Date Investigator became aware of AE Severity: Nature: Causality: Serious/ non-serious Expected/ Unexpected Not related/ Unlikely to be related/ Probably related/ Possibly related/ Definitely related Brief description of AE: (attach additional pages, if required) SOP for SHS IRBs Page 13 of 14