To be completed by the person filling in the form WAHT R&D no.: Subject ID/initials Onset date of Appendix 3 (Page 3 of 4) RESEARCH RELATED /SUSAR INITIAL REPORT 9. Causality and Expectedness (to be completed by physician) Is the related to the *If possibly, probably or definitely In addition to this form, and within 5 drug/device/intervention? related, was the unexpected? days: Not related Yes1 1 - Please complete and return all Unlikely to be related No2 sections of the follow up report form. Possibly related* Probably related* (Unexpected means not described 2 - Please complete and return Definitely related* in the protocol or other product sections 1, 2 and 3 of the follow up report form. information) For blinded studies: Has the randomisation code been broken in making this assessment: Yes* No *If yes, give details of randomisation: 10. Sponsor notification (only complete where sponsor is not WAHT) Has the Sponsor been notified of the /SUSAR? Yes, give date: No+ +Please note, you must inform the Sponsor within 24 hours of becoming aware of the event. 11. Chief/Principal Investigator, or delegated physician (at this site) Name: Job title/role in study: Contact address: Email address: Telephone No: Fax number: Signature: I confirm that the contents of this form (pages 1, 2, 3 ± 4) are accurate and complete Please tick this box if section 12 (next page) has been used: Signature of person making report:_______________________________Date:____/____/____ R&D use only: case reference number Date Received To be completed by the person filling in the form WAHT R&D no.: Subject ID/initials Onset date of Appendix 3 RESEARCH RELATED /SUSAR INITIAL REPORT (Page 4 of 4) 12. Additional information (refer to section number) Section no. Further information
To be completed by the person filling in the form WAHT R&D no.: Subject ID/initials Onset date of Appendix 3 RESEARCH RELATED /SUSAR INITIAL REPORT (Page 3 of 4) 9. Causality and Expectedness (to be completed by physician) Is the related to the drug/device/intervention? Not related Unlikely to be related Possibly related* Probably related* Definitely related* *If possibly, probably or definitely related, was the unexpected? Yes1 No2 (Unexpected means not described in the protocol or other product information) In addition to this form, and within 5 days: 1 - Please complete and return all sections of the follow up report form. 2 - Please complete and return sections 1, 2 and 3 of the follow up report form. For blinded studies: Has the randomisation code been broken in making this assessment: Yes* No *If yes, give details of randomisation: 10. Sponsor notification (only complete where sponsor is not WAHT) Has the Sponsor been notified of the /SUSAR? Yes, give date: No+ +Please note, you must inform the Sponsor within 24 hours of becoming aware of the event. 11. Chief/Principal Investigator, or delegated physician (at this site) Name: Job title/role in study: Contact address: Email address: Telephone No: Fax number: Signature: I confirm that the contents of this form (pages 1, 2, 3 ± 4) are accurate and complete Please tick this box if section 12 (next page) has been used: Signature of person making report:_______________________________Date:____/____/____ R&D use only: case reference number Date Received To be completed by the person filling in the form WAHT R&D no.: Subject ID/initials Onset date of Appendix 3 RESEARCH RELATED /SUSAR INITIAL REPORT (Page 4 of 4) 12. Additional information (refer to section number) Section no. Further information
Adverse%20event%20forms.docx