ID
42876
Beschrijving
Formblatt für die Meldung von schwerwiegenden unerwünschten Ereignissen (SAE) im Rahmen einer klinischen Prüfung oder Leistungsbewertungsprüfung durch Sponsoren nach § 3 Abs. 5 der MPSV Die Vorlage dieser Meldung stellt an sich keine Schlussfolgerung des Herstellers und / oder seines Bevollmächtigten bzw. der zuständigen Behörde dar, dass der Inhalt dieser Meldung vollständig oder zutreffend ist, dass das (die) aufgeführte(n) Medizinprodukt(e) in irgendeiner Weise versagt und/oder zum angegebenen Tod bzw. zur angegebenen Verschlechterung des Gesundheitszustandes einer Person geführt oder beigetragen hat (haben). Report form for reporting of serious adverse events (SAE) in clinical trials or performance evaluations for use by sponsors according to section 3 (5) of the Ordinance on the Medical Device Safety Plan Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorised representative or the National Competent Authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person
Trefwoorden
Versies (2)
- 20-07-19 20-07-19 -
- 17-09-21 17-09-21 -
Houder van rechten
Bundesinstitut für Arzneimittel und Medizinprodukte
Geüploaded op
17 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Bfarm SAE
Serious Adverse Event Report Form
- StudyEvent: ODM
Beschrijving
Report submitted by
Alias
- UMLS CUI-1
- C3897642
- UMLS CUI-2
- C1710230
Beschrijving
Name
Datatype
text
Alias
- UMLS CUI [1]
- C0027365
Beschrijving
Contact Person
Datatype
text
Alias
- UMLS CUI [1]
- C0337611
Beschrijving
Street, house number
Datatype
text
Alias
- UMLS CUI [1]
- C1301826
Beschrijving
Postal Code
Datatype
float
Alias
- UMLS CUI [1]
- C1514254
Beschrijving
City
Datatype
text
Alias
- UMLS CUI [1]
- C0008848
Beschrijving
Country
Datatype
text
Alias
- UMLS CUI [1]
- C0454664
Beschrijving
Telephone
Datatype
float
Alias
- UMLS CUI [1]
- C1515258
Beschrijving
Fax
Datatype
float
Alias
- UMLS CUI [1]
- C1549619
Beschrijving
Datatype
text
Alias
- UMLS CUI [1]
- C1705961
Beschrijving
Investigator
Alias
- UMLS CUI-1
- C0008961
Beschrijving
Name
Datatype
text
Alias
- UMLS CUI [1]
- C0027365
Beschrijving
Contact Person
Datatype
text
Alias
- UMLS CUI [1]
- C0337611
Beschrijving
Street, house number
Datatype
text
Alias
- UMLS CUI [1]
- C1301826
Beschrijving
Postal Code
Datatype
float
Alias
- UMLS CUI [1]
- C1514254
Beschrijving
City
Datatype
text
Alias
- UMLS CUI [1]
- C0008848
Beschrijving
Country
Datatype
text
Alias
- UMLS CUI [1]
- C0454664
Beschrijving
Telephone
Datatype
float
Alias
- UMLS CUI [1]
- C1515258
Beschrijving
Fax
Datatype
float
Alias
- UMLS CUI [1]
- C1549619
Beschrijving
Datatype
text
Alias
- UMLS CUI [1]
- C1705961
Beschrijving
Medical Device Information
Alias
- UMLS CUI-1
- C1533716
- UMLS CUI-2
- C0025080
Beschrijving
Device Name
Datatype
text
Alias
- UMLS CUI [1]
- C3242369
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1]
- C3274659
Beschrijving
for implants only
Datatype
date
Alias
- UMLS CUI [1,1]
- C0561946
- UMLS CUI [1,2]
- C0011008
Beschrijving
For implants only. To be filled out if the exact implant and explant dates are unknown
Datatype
time
Alias
- UMLS CUI [1,1]
- C0021107
- UMLS CUI [1,2]
- C0449238
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C2963249
- UMLS CUI [1,2]
- C0025080
- UMLS CUI [2,1]
- C0699733
- UMLS CUI [2,2]
- C0332281
- UMLS CUI [2,3]
- C0025080
Beschrijving
Product identifier in the clinical investigation
Datatype
text
Alias
- UMLS CUI [1,1]
- C3272556
- UMLS CUI [1,2]
- C4553154
Beschrijving
Person(s) affected
Alias
- UMLS CUI-1
- C0522476
Beschrijving
Subject
Datatype
boolean
Alias
- UMLS CUI [1]
- C0681850
Beschrijving
User
Datatype
boolean
Alias
- UMLS CUI [1]
- C1706077
Beschrijving
Other Person
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027361
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other Person Further Information
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027361
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1517331
- UMLS CUI [1,4]
- C1533716
Beschrijving
Information on sex, year of birth and weight to be provided if necessary for the assessment of the SAE
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Information on sex, year of birth and weight to be provided if necessary for the assessment of the SAE
Datatype
partialDate
Alias
- UMLS CUI [1]
- C2826771
Beschrijving
Information on sex, year of birth and weight to be provided if necessary for the assessment of the SAE
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Subject ID according to investigation protocol
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826694
- UMLS CUI [1,2]
- C2348563
Beschrijving
Serious adverse event
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Date of the study procedure
Datatype
date
Alias
- UMLS CUI [1,1]
- C0008972
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C0011008
Beschrijving
Date of event
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0441471
Beschrijving
Doctor / Investigation site awareness date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0031831
- UMLS CUI [1,3]
- C1522154
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C2347790
- UMLS CUI [2,3]
- C1522154
Beschrijving
Date the report was received by the sponsor
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C3897642
- UMLS CUI [1,3]
- C1709850
- UMLS CUI [1,4]
- C1711305
Beschrijving
actual or possible
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C1306577
Beschrijving
actual or possible
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C3846017
- UMLS CUI [2,1]
- C1274040
- UMLS CUI [2,2]
- C2826244
- UMLS CUI [2,3]
- C3263722
Beschrijving
actual or possible
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0221099
- UMLS CUI [1,3]
- C0205355
- UMLS CUI [1,4]
- C1268086
- UMLS CUI [2,1]
- C1274040
- UMLS CUI [2,2]
- C0221099
- UMLS CUI [2,3]
- C0205355
- UMLS CUI [2,4]
- C0242821
- UMLS CUI [2,5]
- C0542341
Beschrijving
actual or possible
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [2,1]
- C1274040
- UMLS CUI [2,2]
- C0019993
- UMLS CUI [2,3]
- C0439590
Beschrijving
actual or possible
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C0221099
- UMLS CUI [1,4]
- C0205355
- UMLS CUI [1,5]
- C1268086
- UMLS CUI [2,1]
- C1274040
- UMLS CUI [2,2]
- C0549433
- UMLS CUI [2,3]
- C0221099
- UMLS CUI [2,4]
- C0205355
- UMLS CUI [2,5]
- C1268086
- UMLS CUI [3,1]
- C1274040
- UMLS CUI [3,2]
- C0184661
- UMLS CUI [3,3]
- C0221099
- UMLS CUI [3,4]
- C0205355
- UMLS CUI [3,5]
- C0242821
- UMLS CUI [3,6]
- C0542341
- UMLS CUI [4,1]
- C1274040
- UMLS CUI [4,2]
- C0549433
- UMLS CUI [4,3]
- C0221099
- UMLS CUI [4,4]
- C0205355
- UMLS CUI [4,5]
- C0242821
- UMLS CUI [4,6]
- C0542341
Beschrijving
actual or possible
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0015930
- UMLS CUI [2,1]
- C1274040
- UMLS CUI [2,2]
- C0015927
- UMLS CUI [3,1]
- C1274040
- UMLS CUI [3,2]
- C0000768
- UMLS CUI [4,1]
- C1274040
- UMLS CUI [4,2]
- C2112165
Beschrijving
Detailed description of the event by the investigation site
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348319
- UMLS CUI [1,2]
- C0441471
- UMLS CUI [1,3]
- C2825164
Beschrijving
Additional description by the sponsor
Datatype
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C0678257
- UMLS CUI [1,3]
- C2347796
Beschrijving
Remedial action taken by the investigation site relevant to the care of the subject
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709895
- UMLS CUI [1,2]
- C2825164
- UMLS CUI [1,3]
- C1947933
- UMLS CUI [1,4]
- C0681850
Beschrijving
expected = addressed in the risk analysis of the sponsor or mentioned in the Investigators Brochure
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0679138
- UMLS CUI [1,2]
- C0441471
Beschrijving
Rationale for the classification as expected or unexpected
Datatype
text
Alias
- UMLS CUI [1,1]
- C2699007
- UMLS CUI [1,2]
- C0008902
- UMLS CUI [1,3]
- C1517001
- UMLS CUI [2,1]
- C2699007
- UMLS CUI [2,2]
- C0008902
- UMLS CUI [2,3]
- C4055646
Beschrijving
Initial actions taken by the sponsor
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205265
- UMLS CUI [1,2]
- C3266814
- UMLS CUI [1,3]
- C1711305
Beschrijving
Related to investigation
Alias
- UMLS CUI-1
- C0869014
- UMLS CUI-2
- C0220825
Beschrijving
Relation to investigation Medical procedure
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0869014
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C0199171
Beschrijving
Relation to investigation Medical device
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0869014
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C0025080
Beschrijving
No relation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0869014
- UMLS CUI [1,2]
- C1705492
Beschrijving
in case of changes in rating the relation compared to initial or follow-up reports please provide a rationale
Datatype
text
Alias
- UMLS CUI [1,1]
- C2699007
- UMLS CUI [1,2]
- C0871208
- UMLS CUI [1,3]
- C0869014
Beschrijving
Number of patients currently enrolled At the investigation site
Datatype
float
Alias
- UMLS CUI [1,1]
- C2360800
- UMLS CUI [1,2]
- C4727055
- UMLS CUI [1,3]
- C2825164
Beschrijving
Number of patients currently enrolled All investigation sites
Datatype
float
Alias
- UMLS CUI [1,1]
- C2360800
- UMLS CUI [1,2]
- C4727055
- UMLS CUI [1,3]
- C2825164
- UMLS CUI [1,4]
- C0444868
Beschrijving
Final report by the sponsor
Alias
- UMLS CUI-1
- C0460114
- UMLS CUI-2
- C2347796
Beschrijving
Root cause of the SAE is
Datatype
text
Alias
- UMLS CUI [1,1]
- C3179036
- UMLS CUI [1,2]
- C1519255
Beschrijving
Please provide information if other was picked on the previous item
Datatype
text
Alias
- UMLS CUI [1,1]
- C3179036
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1517331
- UMLS CUI [1,5]
- C1533716
Beschrijving
including a final risk-benefit assessment of the clinical investigation taking all SAEs into consideration
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2,1]
- C2699007
- UMLS CUI [2,2]
- C3179036
- UMLS CUI [2,3]
- C0008902
Beschrijving
Corrective action taken or planned including time schedule:
Datatype
text
Alias
- UMLS CUI [1,1]
- C0719519
- UMLS CUI [1,2]
- C3266814
- UMLS CUI [1,3]
- C1301732
- UMLS CUI [1,4]
- C1549502
- UMLS CUI [2,1]
- C0719519
- UMLS CUI [2,2]
- C3266814
- UMLS CUI [2,3]
- C1272695
- UMLS CUI [2,4]
- C1549502
Similar models
Serious Adverse Event Report Form
- StudyEvent: ODM
C1273803 (UMLS CUI [1,2])
C0681788 (UMLS CUI [1,3])
C4553154 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C3897642 (UMLS CUI [1,2])
C0586393 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C1273803 (UMLS CUI [1,2])
C0681788 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
C0586393 (UMLS CUI [1,5])
C1273803 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C3897642 (UMLS CUI [1,4])
C1515023 (UMLS CUI [1,5])
C1550543 (UMLS CUI [1,2])
C1301860 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C4724350 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,2])
C0699733 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0025080 (UMLS CUI [2,3])
C4553154 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C1533716 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0441471 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,2])
C1522154 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2,1])
C2347790 (UMLS CUI [2,2])
C1522154 (UMLS CUI [2,3])
C3897642 (UMLS CUI [1,2])
C1709850 (UMLS CUI [1,3])
C1711305 (UMLS CUI [1,4])
C1306577 (UMLS CUI [1,2])
C3846017 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C3263722 (UMLS CUI [2,3])
C0221099 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C1268086 (UMLS CUI [1,4])
C1274040 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0205355 (UMLS CUI [2,3])
C0242821 (UMLS CUI [2,4])
C0542341 (UMLS CUI [2,5])
C0019993 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0439590 (UMLS CUI [2,3])
C0184661 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0205355 (UMLS CUI [1,4])
C1268086 (UMLS CUI [1,5])
C1274040 (UMLS CUI [2,1])
C0549433 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
C0205355 (UMLS CUI [2,4])
C1268086 (UMLS CUI [2,5])
C1274040 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0221099 (UMLS CUI [3,3])
C0205355 (UMLS CUI [3,4])
C0242821 (UMLS CUI [3,5])
C0542341 (UMLS CUI [3,6])
C1274040 (UMLS CUI [4,1])
C0549433 (UMLS CUI [4,2])
C0221099 (UMLS CUI [4,3])
C0205355 (UMLS CUI [4,4])
C0242821 (UMLS CUI [4,5])
C0542341 (UMLS CUI [4,6])
C0015930 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C0015927 (UMLS CUI [2,2])
C1274040 (UMLS CUI [3,1])
C0000768 (UMLS CUI [3,2])
C1274040 (UMLS CUI [4,1])
C2112165 (UMLS CUI [4,2])
C0441471 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C2825164 (UMLS CUI [1,2])
C1947933 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,4])
C0008902 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C2699007 (UMLS CUI [2,1])
C0008902 (UMLS CUI [2,2])
C4055646 (UMLS CUI [2,3])
C3266814 (UMLS CUI [1,2])
C1711305 (UMLS CUI [1,3])
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI [1,2])
C0199171 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C1705492 (UMLS CUI [1,2])
C0871208 (UMLS CUI [1,2])
C0869014 (UMLS CUI [1,3])
C4727055 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
C4727055 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
C0444868 (UMLS CUI [1,4])
C2347796 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1517331 (UMLS CUI [1,4])
C1533716 (UMLS CUI [1,5])
C0220825 (UMLS CUI [1,2])
C2699007 (UMLS CUI [2,1])
C3179036 (UMLS CUI [2,2])
C0008902 (UMLS CUI [2,3])
C3266814 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1549502 (UMLS CUI [1,4])
C0719519 (UMLS CUI [2,1])
C3266814 (UMLS CUI [2,2])
C1272695 (UMLS CUI [2,3])
C1549502 (UMLS CUI [2,4])