UoL FORM RSC-003 – SAFETY REPORTING

SERIOUS ADVERSE EVENT / SERIOUS ADVERSE REACTION / SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS REPORTING FORM

Please refer to the Pharmacovigilance SOP (JOINT R&D OFFICE SOP CLIN109AE Reporting V3) (available through the College of Medicine, Biological Sciences and Psychology Research Webpages) which details reporting procedures for SAEs, SARs and SUSARs.

(Type in the grey boxes, which will enlarge to fit text)

UoL No: / Ethics Ref No: / MREC No:
EudracT No:
Study Title:
CTA No:
Patient ID or initials (if appropriate)
Date of onset of SAE/SAR/SUSAR: / Time:

1) Please indicate whether the event falls within the category of:

SAE

SAR

SUSAR

2) Nature of the SAE / SAR / SUSAR: (Click on box to indicate/check)

Resulted in death

Life threatening

In-patient hospitalisation or prolongation of existing hospitalisation

Persistent or significant disability/incapacity

Congenital anomaly/birth defect (diagnosed in offspring of a subject who received study drug)

Other (not covered by categories but, in the investigator’s opinion, should be considered serious)

2) Briefly describe the event & attach photocopy of Sponsor Company SAE form (if applicable)

3) Was the incident related to the patient's involvement in the study?

LikelyPossibleUnlikely

4) Is the event related to a break in the study protocol or protocol violation?

Possible Unlikely

if “possible” or “likely”, please give details below (or attach additional sheets)

5) Action taken regarding patient participation in the study:

Patient Died

Temporarily DiscontinuedDate: Decision taken by:

Permanently DiscontinuedDate: Decision taken by:

Event Continuing

Recovered

Patient Continued In Study

(click on box to indicate/CHECK)

6) Do these adverse events influence your opinion concerning the safety of study drug / devices / equipment / questionnaires?

Yes No

7)Do you intend to continue participating in the study?

Yes No

8)Do you wish to amend the study as a result of the adverse event report?

Yes No

If yes, please state how (this will also require a protocol amendment)

Number of additional pages attached:

Principal Investigator’s Signature: / Date
Name:
Position:
Contact Number:
Department / contact address

Please return the completed form, and copies of all additional documents,in a sealed envelope, headed “SAE/SAR/SUSAR(delete as appropriate)Notification”, to:

University Research Governance Manager

Research and Development Office

University Hospitals of Leicester NHS Trust

LeicesterGeneral Hospital

Gwendolen Road

Leicester

LE5 4PW

If submitting an urgent notification of an SAE, or a part completed Safety Reporting Form, awaitingfurther information or signature by the Chief/Principal Investigator, the form may be emailed or faxed to the R&D Office (until a fully completed form is ready to be sent as described above):

For email, send to AND COPY TO: d

Fax No: (0116) 2584226

N.B. The R&D Office will forward notificationsof SUSARs to the MHRA and the relevant Research Ethics Committees.

UOL FORM RSC-003 Revised April 2011Page 1 of 3