Dose Details Indication Batch number Expiry date Start date of drug Stop date or state if ongoing If stopped/lowered dose, did the resolve after this? (Tick ONE) Yes No N/A If reintroduced did the event reappear? (Tick ONE) Yes No N/A Attach supplemental pages if there are more than 2 study drugs 6. Details (If applicable) Date of death Cause of death Cause of death obtained from (Tick ONE) Working diagnosis Coroners inquest Death Certificate 7. Relevant medical/surgical history No. of medical/surgical history CRF pages attached: If no CRF pages attached, describe details of medical history : 8. Concomitant Medication No. of concomitant CRF pages attached: If no CRF pages attached, describe details of conc. meds : 9. Study Details Study title Protocol Version or date Eudract No. Study Design Open label Single blind Double blind If blinded, broken? (Tick ONE) Consider unblinding if SUSAR Yes No N/A 10. Principal Investigator Details (site specific, and if different from Chief Investigator Name of PI Address
Dose Details Indication Batch number Expiry date Start date of drug Stop date or state if ongoing If stopped/lowered dose, did the resolve after this? (Tick ONE) Yes No N/A If reintroduced did the event reappear? (Tick ONE) Yes No N/A Attach supplemental pages if there are more than 2 study drugs 6. Details (If applicable) Date of death Cause of death Cause of death obtained from (Tick ONE) Working diagnosis Coroners inquest Death Certificate 7. Relevant medical/surgical history No. of medical/surgical history CRF pages attached: If no CRF pages attached, describe details of medical history : 8. Concomitant Medication No. of concomitant CRF pages attached: If no CRF pages attached, describe details of conc. meds : 9. Study Details Study title Protocol Version or date Eudract No. Study Design Open label Single blind Double blind If blinded, broken? (Tick ONE) Consider unblinding if SUSAR Yes No N/A 10. Principal Investigator Details (site specific, and if different from Chief Investigator Name of PI Address
CTRG_form_312a_SAE_reporting_v2.0_29Mar2017.docx