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Research Department

Serious adverse event Report form

STH Sponsored Studies
All SAEs must be reported to the Research Department within 24 hours of discovery of the event by the research team
Instructions for use
  • Complete electronically (to ensure legibility) marking as initial or follow up
  • If the form is not completed by the PI, ensure that it is reviewed and signed by the PI
  • Email to ensuring the word “SAE” appears in the subject title, or Fax to 0114 2265937
  • If you are not able to obtain the signature of the PI immediately, please send an unsigned form, following this up with a signed version as soon as possible

project details

1. STH Number

/ STHXXXXX / 2. Principal Investigator / (Name )
3. Study Title (Short) / (Title)

type of Report

4.What are you reporting?

/ SAE ☐ / SUSAR[1] ☐ / Notable Event[2]☐

5. What type of report is this?

/ Initial ☐ / Follow up ☐ / Follow up report # ______
6. Reporting Person / (Name and position) / 7. Date of this report / 8. Date research team became aware of event
9. Study site (if multicentre) / (Name of site)

PARTICIPANT DETAILS

10. Participant study number / ______/ 11. Participant initials / ______
12. Sex / (M/F) / 13. Date of birth
14. Weight / (KG)

STUDY DRUG(S)

15. Drug name (add a new line for each drug) / 16. Date started / 17. Date of last administration / 18. Frequency of administration[3] / 19. Dose / 20. Route[4]
event details
21. Event start date / 22. Event end date (or date of death)
23. Description of event / (Summary of signs and symptoms, diagnosis, treatment of event, other relevant medical history)
24. Seriousness / 25. Frequency / 26. Intensity / 27. Action taken / 28. Outcome
☐Death
☐Life Threatening
☐Inpatient Hospitalisation
☐Prolonged Hospitalisation
☐Persistent or Significant Disability/Incapacity
☐Congenital Abnormality/Birth Defect / ☐Isolated
☐Intermittent
☐Continuous
☐Unknown / ☐Mild
☐Moderate
☐Severe / ☐None
☐Reduce Dose
☐Drug Withdrawn
☐Specific Treatment
☐Other / ☐Recovered
☐Recovering
☐Not Recovered
☐Recovered with Sequelae
☐Fatal
☐Unknown

Relationship to Study drug

29. In the PIor other medically qualified doctor’sopinion, what is the relationship between the event and a study drug? / ☐Definite* * This will be reported as a SAR[5]
☐Probable*
☐Possible*
☐Unlikely – please provide alternative explanation for the cause of the event:
☐Unrelated – please provide alternative explanation for the cause of the event:
☐Not assessable – data to follow (this will be reported as a SAR until/unless a negative relationship has been confirmed)
30. If you suspect the event is related, please identify suspect drugwhere possible

Expectedness

(Only complete this section if the relationship of the event to the study drug is definite, probable, possible or not assessable)
31. Is the event expected, for this study drug as described in the Reference Safety Information (RSI) within the Investigator Brochure (IB) or Summary of Product Characteristics (SmPC)? / Yes/No/data to follow
32. What version and date of IB or SmPC was used to assess the expectedness (this should be the Sponsor approved version). For SmPC please refer to the date of revision of text on the final page.

Concomitant Medication- PLEASE ONLY COMPLETE WHERE EVENT IS A SUSAR(All medication taken within the last 30 days – include over the counter and herbal medicines)

33. Drug name / 34. Date drug started / 35. Date drug stopped

Principal Investigator Signature

36. Signature / 37. Print Name / (Name) / 38. Date

database entry (admin only)

39. Entered to RMS by / Name / 40. Date entered to RMS
41. Reviewed by / Name / 42. Date reviewed

STHXXXXX

______SAE Report Form V5.1, 01 Feb 2018

Page 1

[1] Please note that if you are reporting a SUSAR the randomisation code for this participant must be unblinded

[2] If the event is classed as serious, but is seen as a “notable event” the PI must inform the Sponsor who will report this to the MHRA following the same timelines as for reporting a SUSAR.

[3]Once daily, twice daily, 3 times daily, 4 times daily, as necessary, other

[4]Unknown, per os (mouth), intravenous, intramuscular, subcutaneous, per vagina, per rectum, topical, inhalation, other

[5]SAR = Serious Adverse Reaction. i.e. related to the drug