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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: |
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