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Serious Adverse Event / SUSAR Reporting Form When completing this form please refer to: “SOP Guidance on Adverse Event Recording, Reporting & Reviewing for Researchers” 1. Project Identifiers: Sponsor R&D No: Sponsor SAE ref Number: (To be completed by Sponsor only): OTHER: EudraCT No: Project Title: 2. Site details: Reporting Site: Reported By: Reporters Contact Details: Date of Report: Address: __ __ / __ __ / __ __ __ __ dd / mm / yyyy Tel: Email: Fax: 3.. Subject Identifiers: Initials: Unique Study Identifier: Date of Birth: __ __ / __ __ / __ __ __ __ dd / mm / yyyy Ethnicity:(delete as appropriate) Asian / Black / Caucasian Other: please specify; Sex: Male Female 4. Event/Reaction Information: Date of Onset of Event: __ __ / __ __ / __ __ __ __ dd / mm / yyyy Time of Onset of Event: ____ __: __ __ 24h clock Date Deemed Serious: __ __ / __ __ / __ __ __ __ dd / mm / yyyy Time Deemed Serious: ____ __: __ __ 24h clock Event / Reaction: Description of Event: e.g. Lab Tests/Results, Signs & Symptoms related to Diagnosis 5. Serious Criteria (tick all that apply) Death Life Threatening Hospitalisation/Prolongation of hospitalisation Persistent or Significant Disability or Incapacity Congenital anomaly or birth defect Other (maybe protocol specific) - Specify:____________________________________ Serious Adverse Event Report - Page 1 of 4 Version 2 02/11/11 Serious Adverse Event / SUSAR Reporting Form 6. Causality: Detail all possible and suspected causes: 7. Relationship of the Reaction to the Investigational Medicinal Product? Definite Probable Possible Not Related 8. If related to the Medicinal Product was the reaction unexpected (Suspected Unexpected Serious Adverse Reaction - SUSAR)? Yes No Not Applicable 9. Classification of Event: CTIMPs: Non CTIMPS SAE: serious – not related to IMP SAR related to IMP – not unexpected SUSAR – Suspected Unexpected Serious Adverse Reaction SAE – Serious - Not related to trial treatment SAE – Serious, Related to trial treatment AND unexpected 10. Investigational Medicinal Product Information – Detail all IMPs: IMP Name Dose Route Date of first (include 1.oral administration* units) 2.IV 3.SC 4.Other: specify Start date of latest Date of Last IMP administration** Administration*** __ __ / __ __ / __ __ __ __ __ / __ __ / __ __ __ __ __ __ / __ __ / __ __ __ __ __ dd / mm / yyyy dd / mm / yyyy dd / mm / yyyy __ __ / __ __ / __ __ __ __ __ / __ __ / __ __ __ __ __ __ / __ __ / __ __ __ __ __ dd / mm / yyyy dd / mm / yyyy dd / mm / yyyy __ __ / __ __ / __ __ __ __ __ / __ __ / __ __ __ __ __ __ / __ __ / __ __ __ __ __ dd / mm / yyyy dd / mm / yyyy dd / mm / yyyy __ __ / __ __ / __ __ __ __ __ / __ __ / __ __ __ __ __ __ / __ __ / __ __ __ __ __ dd / mm / yyyy dd / mm / yyyy dd / mm / yyyy __ __ / __ __ / __ __ __ __ __ / __ __ / __ __ __ __ __ __ / __ __ / __ __ __ __ __ dd / mm / yyyy dd / mm / yyyy dd / mm / yyyy *Date of first administration; when the IMP was given/taken for the 1 st time **Start date of latest administration; if the drug is given in cycles, enter the start date of the latest cycle, if drug has been continuous since date of first administration- please mark as ‘continuous’ ***Date of last administration; when the drug was last given/taken Serious Adverse Event Report - Page 2 of 4 Version 2 02/11/11 Serious Adverse Event / SUSAR Reporting Form 11. Action Taken: Detail treatment and any action taken: dates of treatment and/or best estimate of treatment duration; None Dose reduction details: IMP Treatment delayed details: IMP Treatment delayed and dose reduced details: IMP Treatment permanently discontinued details: Other details: 12. Event Outcome: Tick One a) Resolved: date of recovery: __ __ / __ __ / __ __ __ __ dd / mm / yyyy b) Ongoing: If yes, details: c) Recovered with sequelae: If yes, date:__ __/ __ __ / __ __ __ __ dd / mm / yyyy Details: d) Subject Died: If yes, date of death: __ __ / __ __ /__ __ __ __ dd / mm / yyyy e) Unknown: 13. Principal Investigator Name of Principal Investigator at reporting site: PLEASE PRINT Signature: Serious Adverse Event Report - Page 3 of 4 Date: __ __ / __ __ / __ __ __ __ dd / mm / yyyy Version 2 02/11/11 Serious Adverse Event / SUSAR Reporting Form 14. Chief Investigator Chief Investigator: PLEASE PRINT Confirm Classification: Yes No if no state reason and re-classify: Reason: Re-classification: CTIMPs: Non CTIMPS SAE: serious – not related to IMP SAR related to IMP – not unexpected SUSAR – Suspected Unexpected Serious Adverse Reaction SAE – Serious - Not related to trial treatment SAE – Serious, Related to trial treatment AND unexpected Signature: Serious Adverse Event Report - Page 4 of 4 Date: __ __ / __ __ / __ __ __ __ dd / mm / yyyy Version 2 02/11/11 Serious Adverse Event / SUSAR Reporting Form REPORTING INSTRUCTIONS Send Copy to R&D within 24hrs from becoming aware of the by either: 1. email a copy to: [email protected] or 2. Fax a copy to: 0115 8493295 Any queries please contact a member of staff in the Research & Innovations department: Telephone: 0115 9709049 or 0115 9249924 ext 70659 or 70660 A copy should also be sent to the Chief Investigator & Retain form in the Investigator Site File Serious Adverse Event Report - Page 5 of 4 Version 2 02/11/11