855. EPMO Open Source Coordination Office Redaction File Detail Report

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855.1 Files compared

# Location File Last Modified
1 RAMS-2.3.0.zip\RAMS-2.3.0\Webapp\RAMS-2.3.0\RAMS-2.3.0.war\WEB-INF\classes IACUC-adverse-Event-Form_61.docx Wed May 2 23:26:00 2018 UTC
2 RAMS-2.3.0.zip\RAMS-2.3.0\Webapp\RAMS-2.3.0\RAMS-2.3.0.war\WEB-INF\classes IACUC-adverse-Event-Form_61.docx Tue Jul 17 21:40:58 2018 UTC

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  1   IACUC Prot ocol No.:            
  2   Protocol T itle:     
  3   Principal  Investigat or:       
  4   Date:     
  5    
  6   UNANTICIPA TED PROBLE M DESCRIPT ION
  7    
  8    
  9   Classifica tion(s) of  unanticip ated event :
  10  
  11  
  12   Levels of  mortality  experience d are > 15 % that ant icipated i n the appr oved proto col 
  13  
  14    
  15    Mortality  due to co mplication s unantici pated in t he approve d protocol
  16  
  17  
  18  
  19    High “clu ster” mort ality (Clu ster morta lity is de fined as a  grouping  of animal  deaths occ urring clo sely toget her, signi ficantly a bove antic ipated stu dy loss le vels
  20  
  21  
  22  
  23   Morbidity/ non-fatal  complicati ons signif icantly be yond that  anticipate d in the a pproved pr otocol, es pecially t hose creat ing diffic ult to man age levels  of pain a nd distres s. 
  24  
  25     
  26    Other (li st):     
  27  
  28    
  29   Summarize  the excess ive or una nticipated  mortality  or morbid ity being  reported i ncluding:
  30  
  31   a) Species  involved:      
  32  
  33  
  34  
  35   b) Number  of animals  impacted:      
  36  
  37  
  38  
  39   c) Animal  identifica tion numbe r(s) – if  applicable :     
  40  
  41  
  42  
  43   d) Date or  date rang e of incid ent(s):      
  44  
  45  
  46  
  47  
  48  
  49  
  50  
  51   e)  A shor t narrativ e describi ng the una nticipated  events oc curring (p lease list  and compa re with th e anticipa ted nature  and frequ ency of mo rbidity or  mortality  listed in  the curre ntly appro ved protoc ol):     
  52  
  53  
  54  
  55   f) Prelimi nary consi derations  as to the  pathogenes is of the  adverse ev ent(s):       
  56  
  57  
  58  
  59   g) Any exi sting or p ending dia gnostics o r other da ta that ma y help to  explain th e cause of  the unant icipated e vent:     
  60  
  61  
  62  
  63   h) Any add itional in formation,  review of  circumsta nces or ot her detail s that may  be helpfu l in revie wing the m atter:       
  64  
  65  
  66  
  67  
  68   Has there  been prior  communica tion or co nsultation  with the  ARF Staff  and/or vet erinarian  concerning  this/thes e event(s) ?   YES      NO
  69  
  70   If yes, pl ease summa rize        
  71  
  72  
  73  
  74  
  75  
  76   In the spa ce below,  describe t he Correct ive Action  Plan (CAP ) to reduc e or preve nt future  morbidity  or mortali ty:
  77        
  78  
  79  
  80  
  81  
  82   Please not e the foll owing in c onjunction  with unan ticipated  event fili ng:
  83  
  84   a) Events  listed in  this form  should be  summarized  and inclu ded in the  next Annu al Renewal  Applicati on for the  protocol.
  85  
  86   b) If leve ls of morb idity or m ortality e xperienced  cannot be  maintaine d at level s specifie d in the p rotocol, a  modificat ion must b e filed re questing a djustment  to the new  levels or  complicat ions being  experienc ed.
  87  
  88   c) All una nticipated  event rep orts filed  are revie wed by the  full IACU C and the  committee  maintains  the right  of final a pproval of  the CAP.  Additional  stipulati ons may be  required  by the Com mittee. 
  89  
  90  
  91  
  92   __________ __________ __________ __________ Date:     
  93   Signature  of Princip al Investi gator 
  94  
  95  
  96    
  97    _________ __________ __________ __________ ______                                                                                                            
  98   Signature  of ARF Sup ervisor or  Veterinar ian consul ted                   Date: