SAE/SAR/ Follow up Report Form

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Form
SAE/SAR Follow Up Report Form
Non-CTIMP studies
This form accompanies the Guidance Document RI/QMS/SOP/013c (Safety Reporting: Studies other than Clinical Trials of Investigational Medicinal Products (non-CTIMPs))
REFERENCE: / RI/QMS/SOP/013e
VERSION NUMBER: / 1.0
EFFECTIVE DATE: / 18-02-16
REVIEW DATE: / 18-02-18
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 / REVIEW DATE / REASON FOR CHANGE
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/ Follow Up Report Form

Non-CTIMP studies

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.
Follow up forms should be submitted if new information becomes available, or when an event is resolved.
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

*must be the same as the number provided on the original SAE report form

EVENT DETAILS D D M M Y Y Y Y h h m m
Is the event resolved? / Resolved add an end date to the box below
Ongoing leave the end date blank and submit a follow up report as soon as possible
Patient died
Event End Date & Time: / - / - / -
EVENT UPDATE
DESCRIBE ANY FURTHER INFORMATION OR ACTION TAKEN SINCE THE INITIAL REPORT.
Include relevant details including whether the participant has been withdrawn from the trial, treatment has been withdrawn, the patient has been unblinded, etc.
PI CONFIRMATION
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:
For Internal use onlyto be completed by R&I WHEN REPORT IS RECEIVED
Additional follow up required? / Yes (required if event is ongoing)
No
Report reviewed by: / Name/Role:
Signature:
Date:

Version 1.0/18-02-16/ Page 1 of 3

RI/QMS/SOP/013e