Serious Adverse Event Reporting Form
Clinical Investigations of Medical Devices
For queries regarding this report please telephone 0115 9709049
Submit to Nottingham University Hospitals NHS Trust Research and Innovation department by one of the following methods:
☐Email () / ☐Fax(0115 8493295) / ☐Hand Deliver (R&I, NHSP, C Floor, South Block, QMC)
Section 1: Study Information
Study Title: / Site Address/Number:
Chief Investigator: / Principal Investigator:
R&I RefNumber: / MHRA Ref Number:
Section 2: Participant Information
Initials: / Participant Number: / Gender: / ☐Male ☐Female
Section 3: Event Information
Date of Report: / Date of Event Onset: / Date Site became aware: / Time Site Became Aware:
Event:
Description of Event:
Specify diagnosis or cause of death if known; otherwise provide signs and symptoms, relevant tests/results. Do NOT use abbreviations
Seriousness Criteria / Event Outcome
Death / ☐ / Fatal (Give cause of death if known in event description) / ☐ / Date of death
Life threatening / ☐ / Recovered/Resolved / ☐ / Date recovered
Hospitalisation or prolongation of hospital stay / ☐ / Recovered/Resolved with sequelae (Give detail in event description) / ☐ / Date recovered
Persistent or significant disability or incapacity / ☐ / On-going (Give detail in event description) / ☐ /
Congenital abnormality or birth defect / ☐ / Unknown at time of report / ☐ /
Otherwise considered serious / ☐
^To be completed by a medically qualified doctor only
^Severity of Event: / ^Causality – related to device? / ^Cause of Event: (Detail all possible and suspected causes, including relevant medical history)
Mild / ☐ / Not related / ☐ /
Moderate / ☐ / Related / ☐ /
Severe / ☐ /
^Section Completed by:
(If different from PI) / Name (PRINT) / Signature / Date
Section 4: Study Medical Device Information
Participant has been fitted/used/treated with the device / ☐No (Give reason i.e. screening) …………………………………………………......
☐Yes (Provide details below)
Name of device (or suspected device if blinded) / Indication(s) for Use / Route of administration/fitting / Date of First use / Date of Last use
Section 5: Action Taken as Result of Event:
None / ☐ / Details including new schedule, other therapies, concomitant medication etc.
Device schedule adjusted / ☐ / Tick if concomitant medication is listed on a separate sheet and indicate number of pages ☐Pages:
Device permanently discontinued / ☐
Non-drug therapy administered / ☐
Other (i.e. treated with concomitant medication(s)) / ☐
Unknown at time of report / ☐
Section 6: Participant Status
Blind Broken: / ☐Not Applicable / ☐ Yes / ☐ No
☐Continuing in the trial
☐Completed the trial / Date of Completion:
☐Withdrawn from the trial / Date of Withdrawal:
Section 7: Additional Information
Section 8: Completion Details
Report Completed by:
Name (PRINT) / Signature / Date
PI Review:
(If not reporter)
Name (PRINT) / Signature / Date
FOR SPONSOR USE ONLY
Report Received by:
Name (PRINT) / Date / Time
Report Checked and Tracked by:
Name (PRINT) / Date / Time
Comments:
Medical Monitor Assessment
Causality Assessment: / ☐Not Related (SAE) / Expectedness Assessment:
(if related) / ☐Expected (SADE) / SAE Follow up Required: / ☐Yes
☐Related (SADE) / ☐Unexpected (USADE) / ☐No
Reference Safety Information Used for Expectedness Assessment:
MedDRA Code (if applicable)
Comments:
Assessment Completed by:
Name (PRINT) / Signature / Date
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