Download DSUR Template - Hull and East Yorkshire Hospitals NHS Trust

DSUR [insert report no.]
[Insert brief title or acronym of study]
Development Safety Update Report
 Enter study details in this title page.
 Enter info. in header
 Alter columns and headings in Appendix 2 to match the study
Investigational Medicinal Product (s):
Title of Study:
Eudract no:
REC reference no:
DSUR Report Number:
Period Covered: e.g. 1 September 2010 – 31 August 2011
Sponsor details: Hull and East Yorkshire Hospitals NHS Trust
Sponsor Address: R&D Department, Room 13 2nd floor Daisy Building, Castle Hill Hospital,
Cottingham, East Yorkshire HU16 5JQ
Signed:
………………………………………………..
Name & title:
…………………………………………….....
Date of Report:
……………………………………………….
Note: This Developmental Safety Update Report may contain confidential information,
including unblinded adverse event data.
DSUR template version 1, 21.09.11
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DSUR [insert report no.]
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EXECUTIVE SUMMARY
DSUR template version 1, 21.09.11
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DSUR [insert report no.]
[Insert brief title or acronym of study]
1. Introduction
2. Worldwide Marketing Authorisation
3. Actions taken in the Reporting Period for Safety Reasons
4. Changes to Reference safety Information
5. Inventory of Clinical Trials On-going and Completed During the Reporting Period.
6. Estimated Cumulative Exposure
6.1 Cumulative Subject Exposure in the Study.
6.2 Patient Exposure from Marketing Experience
7. Data in line Listings and Summary Tabulations
7.1 Reference Information
7.2 Line listing of Serious Adverse Reactions (SARs) during the reporting period.
7.3 Cumulative Summary Tabulations of all Serious Adverse Events (SAEs)
8. Significant Findings from the Clinical Trial during the Reporting period
8.1 Completed Trials
8.2 Ongoing Trials
8.3 Long Term Follow Up
8.4 Other therapeutic uses of the IMP
8.5 New Safety Data related to any combination therapies using the IMP
9. Safety Findings from Non-Interventional Studies
10. Other Clinical Trial/Study Safety Information
11. Safety Findings from Marketing Experience
12. Non- Clinical Data
13. Literature
14. Other DSURs
15. Lack of Efficacy
16. Region-Specific Information
DSUR template version 1, 21.09.11
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DSUR [insert report no.]
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17. Late Breaking Information
18. Overall Safety Assessment
18.1
Evaluation of the Risks
18.2
Risk- benefit Considerations
19. Summary of Important Risks
20. Conclusions
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DSUR [insert report no.]
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Appendix 1: Interval Line Listing of Serious Adverse Reactions during the reporting period.
Subject
number


Serious
Country/
adverse
gender/age reaction
(diagnosis)
Outcome
Time to Onset
from
administration
Dose, route of
Suspected administration
drug
and formulation
Comments
Date of
treatment
* Indicates event suspected to be related to the IMP – a serious adverse reaction (SAR)
** Indicates event reported as a Suspected Unexpected Serious Adverse Reaction (SUSAR)
DSUR template version 1, 21.09.11
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DSUR [insert report no.]
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Appendix 2: Cumulative Summary Tabulation of all Serious Adverse Events since start of study.
System Organ Class
(used by MedDRA)
Preferred Term
Infections and infestations
Study drug
Blinded
(code unbroken)
Active comparator
Placebo
Neoplasms benign, malignant and
unspecified (including cysts and polyps)
Blood and lymphatic system disorders
Immune system disorders
Endocrine disorders
Metabolism and nutrition disorders
Psychiatric disorders
Nervous system disorders
Eye disorders
Ear and labyrinth disorders
Cardiac disorders
Vascular disorders
Respiratory, thoracic and mediastinal
disorders
Gastrointestinal disorders
Hepatobiliary disorders
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Skin and subcutaneous tissue disorders
Musculoskeletal and connective tissue
disorders
Renal and urinary disorders
Pregnancy, puerperium and perinatal
conditions
Reproductive system and breast
disorders
Congenital, familial and genetic disorders
General disorders and administration site
conditions
Investigations
Injury, poisoning and procedural
complications
Surgical and medical procedures
Social circumstances
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