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R&D use only: case Date report
reference number received by R&D
SAE/SUSAR INITIAL REPORT FORM Page 1 of 4
JHP/24.02.09
NB: Use this form only for Trust-sponsored clinical trials using investigational medicinal products (IMPs).
A serious adverse event (SAE) becomes a SUSAR (suspected unexpected serious adverse reaction) if the event is suspected
(possibly, probably or definitely) to be related to the IMP and unexpected i.e. not previously documented in any of the product
information (e.g. SPC) or protocol. SUSARs are subject to expedited reporting to the MHRA and Ethics Committee.
ACTION: Within 24hrs of knowledge of event, complete this form electronically, fax to HEY Trust R & D (01482 461886), alert fax
sent (tel R & D 01482 461883), file original signed form in TMF (section 10). Complete & fax SAE/SUSAR follow-up forms within 5
days of knowledge of event with any further information.
1. Person making report
Name:
Job title/role in study:
Contact address:
Email address:
Telephone No: Fax number:
Date became aware of SAE/SUSAR:
2. Details of study
Full Title of Study: Study site (eg
hospital name):
HEY R & D study
ref no:
Ethics no:
EudraCT no
(IMP studies only):
3. Details of subject affected by SAE/SUSAR
Subject study no. Hospital Number Initials DOB Gender Weight Height
4. Details of SAE/SUSAR (further space available in section 16)
Full description of event/reaction, including body site, reported signs and symptoms and diagnosis where possible:
Event is defined as serious because it (tick as many as apply): *Specify:
resulted in death
is/was life-threatening
resulted in persistent or significant disability/incapacity
required hospitalisation
prolonged an ongoing hospitalisation
resulted in a congenital anomaly or birth defect
other – please specify* opposite
Please give further details in section 7 ‘Outcome’
Maximum intensity of event (up until time of Mild Moderate Severe
sending initial report)
Onset Date Onset Time OR End date End time OR Duration
If known Ongoing
If known
23/02/2010
R&D use only: case reference number
To be completed by the HEY R & D Subject Subject
person filling in this form Ref no: Initials: Study no:
SAE/SUSAR INITIAL REPORT FORM Page 2 of 4
5. Details of IMP(s) (further space available in section 16)
Name of study drug(s) Total daily dose Dosing regime Date/time of last
(inc route) dose
6. Details of Concomitant Medication (further space available in section 16)
Name of drug (s) Total daily dose Dosing regime Date/time of last
(inc route) dose
7. Outcome of SAE/SUSAR (further space available in section 16)
Resolved* Ongoing* Died* (give cause, date of death and PM details if
available)
*Give details:
Was the patient withdrawn from the study as a result of the Yes No
SAE/SUSAR?
8. Location of (onset of) SAE/SUSAR
Setting (e.g. hospital*, home, GP, nursing home):
*If SAE/SUSAR occurred on HEY premises give exact location:
9. Action taken and further information (further space available in section 16)
Please describe action taken:
Other information relevant to assessment of case e.g. medical history, family history, test results.
23/02/2010
R&D use only: case reference number
To be completed by the HEY R&D Subject Subject
person filling in this form Ref no: initials Study no
SAE/SUSAR INITIAL REPORT FORM Page 3 of 4
10. Causality
In the opinion of the physician, is the SAE related to the IMP?
Not related Unlikely to be related Possibly* related Probably* related Definitely* related
If the SAE is possibly, probably or definitely related to the IMP, the SAE becomes a SSAR (suspected serious adverse reaction).
Is the SAE a SSAR? Yes No Note: All SSARs need to be reported on the Annual Safety Report.
11. Expectedness
Was the SAE expected? (Expected means described in the Summary of Product Characteristics, patient information leaflet,
protocol, investigator brochure or other product information)
Yes The SAE is not a SUSAR
No * Is the event possibly, probably or definitely related to the IMP? Yes The SAE is a SUSAR
Note: Reports of SUSARs in double-blind trials should be unblinded by contacting pharmacy. No The SAE is not a SUSAR
Has the randomisation code been broken in making this assessment: Yes No
If yes, give details of randomisation:
12. Ethics Committee notification
Has a copy of this report been sent to the Research Ethics Committee (REC) that granted study approval?
Yes, give date: No, reason:
There is no requirement to notify the REC of SAEs unless the SAE involves the death of the study patient.
Only SUSARS need to be reported to the REC.
A SUSAR which is fatal or life-threatening must be reported to the REC as soon as possible and no later than 7 days after
learning of the event. Any additional information must be reported within 8 days of sending the first report.
A SUSAR which is not fatal or life-threatening must be reported as soon as possible and no later than 15 days after learning of
the event.
13. Notification of HEY Trust R & D and Chief Investigator (if multi-centre trial)
Has a copy of this report been sent to HEY Trust R & D and the Chief Investigator (if applicable)?
Yes, give date: No
Please note, you must inform the Trust R & D within 24 hours of becoming aware of the event.
Chief Investigator needs to be informed as soon as possible.
14. IRIS form (if applicable)
If applicable, has the SAE/SUSAR been reported on the HEYH Trust Incident Record (IRIS) form?
Check HEYHT policy CP129 (Managing hazards and incidents) for definitions of incidents that require reporting (section 5).
For electronic IRIS form click on the Incident Reporting icon on the Trust Intranet Homepage.
Yes, give date: No, reason:
15. Principal Investigator (at this site)
Name:
Signature of Principal Investigator:
I confirm that the contents of this form (pages 1,2,3 ± 4) are accurate and complete
Please tick this box if section 16 (next page) has been used:
Signature of person making report:_______________________________Date:____/____/____
23/02/2010
R&D use only: case reference number
To be completed by the HEY R&D Subject Subject
person filling in the SAE form Ref no: initials study no.
SAE/SUSAR INITIAL REPORT FORM Page 4 of 4
16. Additional information (refer to section number)
Section no. Further information
23/02/2010
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