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Form
SAE/SAR/SUSAR Initial Report Form
Clinical Trials of Investigational Medicinal Products
This form accompanies RI/QMS/SOP/013(Safety Reporting: Clinical Trials of Investigational Medicinal Products (CTIMPs))
REFERENCE: / RI/QMS/SOP/013a
VERSION NUMBER: / 3.1
EFFECTIVE DATE: / 28-11-16
REVIEW DATE: / 28-11-18
AUTHOR: / Clinical Trials Manager
REVIEWED BY: / R&I Senior Team
APPROVED BY: / Deputy Director of Research
CONTROLLER: / Contracts & Quality Management Officer
Document Version History
VERSION NUMBER / EFFECTIVE DATE / REASON FOR CHANGE
1.0 / 07-01-11 / Added contact details for R&I
2.0 / 22-03-12 / Form updated in line with SOP and recoded from R&I-F01
3.0 / 18-02-16 / Minor update to ‘Overall Assessment & Action’ section
Current versions of all Research & Innovation SOPs and accompanying documents are available online. If you are reading this document in printed form, please check that the version number and date match the most recent version on the Research & Innovation website:

SAE/SAR/SUSAR Initial Report Form

Clinical Trials of Investigational Medicinal Products

This form must be completed and submitted to the NBT R&I office within 24 hours of becoming aware of the event. Any information not currently available should be forwarded once available, including clinical assessment of relatedness and expectedness.
All reports should be submitted by fax: 0117 4149329 or email:
TRIAL DETAILS / PATIENT DETAILS
Trial Name: / Subject ID:
Trial Site: / Subject Initials:
PI Name: / Date of Birth: / - / -
Event number for this subject* : / Gender: / Male Female

*please number adverse events sequentially for each participant – we will use this number to link this report with any subsequent corresponding follow up reports

EVENT DETAILS D D M M Y Y Y Y h h m m
Event Start Date & Time*: / - / - / -
Team Aware Date & Time: / - / - / -
Is the Event Ongoing? / Yes if yes, leave the end date box blank and submit a follow up report as soon as possible
No if no, add an end date to the box below
Event End Date & Time: / - / - / -
*If this event has previously been recorded as an Adverse Event, please indicate the date it became serious
WHY WAS THE EVENT SERIOUS? PLEASE TICK
Resulted in Death / Resulted in Persistent / Significant Disability
Life-threatening / Resulted in Congenital Anomaly / Birth Defect
Required Hospitalisation / Prolongation / Other:
EVENT DESCRIPTION
DESCRIBE ANY RELEVANT SYMPTOMS, BODY SITE, RELEVANT TESTS & TREATMENTS RECEIVED. CONTINUE ON SEPARATE SHEET IF NECESSARY
SITUATION:
BACKGROUND:
ACTION:
RECOMMENDATION:
SAE discussed with Dr. Date: Time:
Trial Treatment LEAVE THE END DATE BLANK IF TREATMENT STILL ONGOING
Treatment / Therapy / Dose / Cycle Start Date / Cycle End Date / Action
None
Dose Reduced
Delayed & Reduced
Stopped
Concomitant Therapy(ies)* LEAVE THE END DATE BLANK IF TREATMENT STILL ONGOING
Treatment / Therapy / Dose / Cycle Start Date / Cycle End Date / Causality to this treatment / therapy / Action
Definitely
Probably
Possibly
Unlikely
Not related
Not assessable / None
Dose Reduced
Delayed &
Reduced
Stopped
Definitely
Probably
Possibly
Unlikely
Not related
Not assessable / None
Dose Reduced
Delayed &
Reduced
Stopped

*Please list any relevant concomitant therapies.

OVERALL ASSESSMENT & ACTION
THIS SECTION MUST BE COMPLETED BY THE PRINCIPAL INVESTIGATOR OR AUTHORISED DESIGNEE
Overall assessment of causality / relationship to IMP: / Definitelyrelated
Probably related
Possibly related
Unlikely to be related
Not related
If the event is definitely, probably or possibly related to the IMP, please complete these additional two questions:
Additional Question 1: Please provide further details:
Additional Question 2: Expectedness to IMP:
Expected
Unexpected
NB: IF THERE IS A CAUSAL RELATIONSHIP AND THE EVENT IS UNEXPECTED = SUSAR
Linked to Protocol Breach: / No Yes If yes, please also submit separate protocol deviation
form
Linked to other trial procedure (other than IMP): / No Yes If yes, please provide further details in the “event
description” section above
Intensity: / Mild Moderate Severe
Action Taken: / Continued in Trial Temporarily discontinued Permanently discontinued
Assessment undertaken by: (must be the PI or authorised designee) / Name: / Principal Investigator
Authorised designee
Signature*:: / Date::

*PI must either provide wet ink signature or submit this form by email from their professional email account which will act as the PI signature

REPORTER’S DETAILS YOU MAY BE CONTACTED BY THE RESEARCH & INNOVATION OFFICE FOR FURTHER INFORMATION
Report submitted by: / Name/Role:
Date:
WHAT NEXT?

1)Forward this report to the NBT R&I office within 24 hours by fax 0117 4149329.

2)Ensure PI / delegated Dr completes the “Overall Assessment and Action” section of this form. If the PI is unable to review/sign, please submit the form anyway, and send a completed copy of the form within 48 hours.

3)R&I will log and review the report and request any further information required.

4)Please send a follow up report as soon as the event ends (if end date not currently available) or when any new information becomes available. See SOPRI/QMS/SOP/013 (Safety Reporting: Clinical Trials of Investigational Medicinal Products (CTIMPs)) for further information regarding follow-up reporting requirements.

5)SUSARs are subject to strict reporting requirements and must be reported to the MHRA and Research Ethics Committee (REC) which granted approval for the trial to proceed. R&I will coordinate this.

For any further questions, call the R&I office on 0117 4249330
For Internal use onlyTo be completed by R&I upon receipt of report
Form complete? / Yes
No (if no, request missing information)
Follow-up required? / Yes (required if event is ongoing)
No
Report reviewed by: / Name/Role:
Signature:
Date:

Version 3.1/28-11-16/ Page 1 of 4

RI/QMS/SOP/013a