SUSAR inital report - DOC by sae16085

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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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