ÐÏࡱá>þÿ 8:þÿÿÿ7ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿì¥Á1 ð¿Ybjbj²ï²ï 8*Ð…qhÐ…qh Tÿÿÿÿÿÿ·* * ¼¼¼¼¼ÿÿÿÿÐÐÐ8$<ÐÓÚ`````;;;RTTTTTT$­¶c €x¼;;;;;x¼¼``Û�§§§;R¼`¼`R§;R§§VÂ@`ÿÿÿÿ°LP×­…Øÿÿÿÿ�Ž >£0Ó ã Fã ã ¼$;;§;;;;;xxaF;;;Ó;;;;ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿã ;;;;;;;;;* X ‚: Adverse Event (AE) Reporting Form Institutional Review Board (IRB) À¶Ý®ÊÓÆµ Principal Investigator: IRB Protocol #: Email Address: Phone Number: À¶Ý®ÊÓÆµ Extension: Project Title: Adverse Event (AE) Information: 1. Study Location (please check one): ( À¶Ý®ÊÓÆµ ( Other (List all sites involved): 2. Location of Adverse Event: ( À¶Ý®ÊÓÆµ ( Other: ___________________ 3. Seriousness of Event: ( Non-Serious ( Serious but not Life Threatening ( Life Threatening 4. Required Care: ( Emergency Room / Physician: ______________________________________ ( Clinic: ______________________________________ ( Counseling/Referral: ______________________________________ ( No additional care was sought ______________________________________ 5. Event Cause: In your judgment, how likely was the AE caused by the procedures in this protocol? ( Not related ( Unlikely ( Possibly ( Probably ( Definitely 6. Consent Form: Is the risk of this adverse event contained in your consent form? ( Yes ( No 7. Notification: Will participants currently enrolled in the study be notified of this event? ( Yes ( No Adverse Event Summary: Attach a detailed summary describing the circumstances of the adverse event. Include responses given by the subject and the investigator. If relevant, include procedures taken to prevent similar incidents. In your judgment, should the consent form or any portion of the study be revised as a result of this event? ( Yes. An application for continuing review will be submitted to the À¶Ý®ÊÓÆµ IRB indicating the nature of the amendment or modification within 10 days of receiving this adverse event reporting form. If an amendment is not received within 10 days, I understand that my protocol may be suspended. ( No. Although the event was possibly, probably or definitely caused by the study and the risk is not identified in the consent form, I do not wish to amend the protocol for the following reasons (use additional pages as needed). (please see reverse side) PI Certification: I certify that the adverse event information provided is accurate to the best of my knowledge. Further, I agree to submit a completed and original adverse event reporting form along with the required summary of events. ____________________________ _______________ Signature of Principal Investigator Date ___________________________________ ___________________ Signature of Supervising Faculty Member Date ________________________________________________________________________________________________________________________________ FOR À¶Ý®ÊÓÆµ IRB USE ONLY: Date Received: ______________     Revised 06/21/22 page 2 of 2 Revised 06/21/22 page 1 of 2 "C\]çö    & ' ( H I q r Ž � ² ³ ´ à á ý þ   7 8 H I n o ‚ ƒ ˜ ™ Þ þ ÿ V v w Ä ä å , - . / ’ “ ² ³ À ß à ê  3 4 > ] ^ j k À Á Ë Ì Ñ Ò 23üüüöðððððêðêêðäêÛêÛêÕÕêÛêÛêêêêÛêÛêÛêäêÛêêÛêêêÛêêÛêêäêäêÏêÛêêÛêêêÛêêÛêêÛêÏêÛêÛêäêêÛ hÌ]SCJ hÌ]SCJ jððhÌ]SCJ hÌ]SCJ hÌ]SCJ hÌ]SCJ hÌ]SCJhÌ]SR"C\]çö   & ' ( õõëá²²²²¥²v¥.$„0ý„0ý$d%d&d'dNÆÿOÆÿPÆÿQÆÿ]„0ý^„0ýa$ $„0ý„0ý]„0ý^„0ýa$.$„0ý„0ý$d%d&d'dNÆÿOÆÿPÆÿQÆÿ]„0ý^„0ýa$ „0ý„0ý]„0ý^„0ý „0ý„0ý]„0ý^„0ý „0ý„0ý]„0ý^„0ý ( H I ² ³ ´   ‚ ƒ Þ V Ä , - . / ’ “ À ê  > ÐÐÐÐÐÐÐÐÐÐÐÐÐÐÃÐÐÐÐÐÐÐ $„0ý„0ý]„0ý^„0ýa$.$„0ý„0ý$d%d&d'dNÆÿOÆÿPÆÿQÆÿ]„0ý^„0ýa$> j k Ñ Ò ?@A¥ðB¼%�ö$‘ÐÐÐÐÐÐÔ’’’”””””.$„0ý„0ý$d%d&d'dNÆÿOÆÿPÆÿQÆÿ]„0ý^„0ýa$ $„0ý„0ý]„0ý^„0ýa$.$„0ý„0ý$d%d&d'dNÆÿOÆÿPÆÿQÆÿ]„0ý^„0ýa$39:?@AW¥ðB¼ÉÊ%�ö$23‘;<=WijôýÿEFvw´µòÿ&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLÌÍãúñúëúåúááááúñúúúúúúúñúúúÛëúåëáÖááëÐÐúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúúëúá hÌ]SCJ hÌ]S6� hÌ]SCJ hÌ]S hÌ]SCJ hÌ]SCJ jððhÌ]SCJ hÌ]SCJR‘<=WijEFv´µò&'(ÐÐʽÐл»�ÐÐÐÐÐ… „|ü„0ý]„|ü^„0ý+„0ý„0ý$d%d&d'dNÆÿOÆÿPÆÿQÆÿ]„0ý^„0ý $„0ý„0ý]„0ý^„0ýa$„0ý]„0ý.$„0ý„0ý$d%d&d'dNÆÿOÆÿPÆÿQÆÿ]„0ý^„0ýa$()*+,-./0123456789:;<=>?@ABCDõõõõõõõõõõõõõõõõõõõõõõõõõõõõ „|ü„0ý]„|ü^„0ýDEFGHIJKLÍæ    2õõõõõõõõëáÔÒÒÒÒÒÒÒÒÐÒÐÒÎ $„Öü„0ý]„Öü^„0ýa$ „0ý„0ý]„0ý^„0ý „|ü„Öü]„|ü^„Öü „|ü„0ý]„|ü^„0ýãåæÿ     123<=CDEJKPQRSTUVWXYúôúúðèððèððèððèððäðäðääääðÞÞÞÕÕÞÞÞôÞðäðäðððh hh hCJ h hCJh hjhÌ]SUhÌ]S hÌ]SCJ hÌ]SCJ+23QRSTUVWXYýððýîýìýýß $„Öü„0ý]„Öü^„0ýa$ „|ü„0ý]„|ü^„0ýgd h 6&P1�:p h°Ð/ °à=!°"°#�€$�€%°°°°@ �Ðx˜˜žžžžžžž666666666vvvvvvvvv666666>666666666666666666666666666¨6666666666¸666666666666hH66666666666666666666666666666666666666666666666666666666666666666p62ÆÖæö&6FVfv†–ÆÖæö2(Øè&6FVfv†–ÆÖæö&6FVfv†–ÆÖæö&6FVfv†–ÆÖæö&6FVfv†–ÆÖæö&6FVfv†–ÆÖæö&6FVfv†–8XøV~� °ÀЀàð 0@àð 0@àð 0@àð 0@àð 0@àð 0@àð 0@àð 0@àð 0@àð 0@àð 0@àð 0@àð 0@àð 0@66666_HmH nH sH tH 8`ñÿ8 Normal_HmH sH tH VV  Heading 1&$$„Öü„8„øø@&]„Öü^„8`„øøa$CJff  Heading 26$$„0ý„0ý$d%d&d'd@&]„0ý^„0ýa$CJDA òÿ¡D Default Paragraph FontVióÿ³V 0 Table Normal :V ö4Ö4Ö laö (k ôÿÁ( 0No List 4>@ò4 Title$a$5�CJ:J@: Subtitle$a$5�CJbT@b  Block Text0$„0ý„0ý$d%d&d'd]„0ý^„0ýa$CJ4@"4 Header  ÆàÀ!4 @24 Footer  ÆàÀ!PK!éÞ¿ÿ[Content_Types].xml¬‘ËNÃ0E÷Hüƒå-Jœ²@%é‚ÇŽÇ¢|ÀÈ™$ÉØ²§Uû÷LÒTB¨ l,Ù3÷ž;ãr½µÃ˜œ§J¯òB+$ëG]¥ß7OÙ­V‰�æ�j\À{“c‹p/âID±ÜgŒ6wZá�ÚË0s’„îÍùÄÄ=Dèĵw %–—;“r,q©lEØ¢yDQ"Qˆ,=õcì8ÝB,»î“!g‚�¤÷„xMDœ&é“�M…Ð.‰Á/SAð·e›ýÇ^“Q×©ÛøÄF½�¨ƒ|SËŒ÷ÐD¢Ø¥²�bj|ÉÈE²7åC×<bʼN€…pÉr8¯áô�fÜnß§ÓØFrIÆ.�{ˆ1ÙfãV„âÔ…í‘$2±Ÿ‹1„(òŽ˜tÁ÷™}‡¨kðJVºû1Á–»/Î� Ú”ŠQ¿L¸Ã—÷0³â·7¥#„]©f‡ÇVŠÝáÄÍIh…öÆ�¢cïÑçM–Z6/Hß� «ìbW`ÝGv¬ªë è•Ts³œ'÷ˆ°B¶‡C¶‚Ïþt!ñLQ#¾JóxÝ´yJ]ì €C:›À= Ä‹Ó(‡tÁ½RëQ„¬¦®…;^§Üòßeî1¸/�-—¸/A_Y»)ó^Ûôµ6(¦� Ëp¥[±Ü_ˆ¨âªÅ&N¹‘}Ón€îÈjzb’\Ø-ô>Õÿ®÷�ãü‡—ŽûàÃô;nÅV²ºb§³*™ì.ô7«p‹]M‹ñ€|üMMM’# ud9cÝô47=�ÿ¿ïiVÝÏ7�̪~㦓ñ¡Ã¸édfÕÓÉÍ ô5jà‘ zôØ'^9õJ{rJñžÐƒÏ3A•œžxâ| ˜FðU•9ØÀÂ…i�3ù‘Q/B)L‡Ê¾RŠ™êPx)04ÒËNÝ O'ñ> ²ag¹¬›YeHë¥j¾ƒ*™¡kõb€—«×lC=h�P²W!alf“Øp�¨Ï•‘ôXŒæ ¡OöAXl:XÜVêç®ZbÔr¯À·�é ¿Z‚y4ç�òSæê¹wµ3?¤§WÓŠh°çPxzSq]y Y >*ÿÿÿÿ /OQSV3ãY ( > ‘(D2Y ð8ð@ñÿÿÿ€€€÷ð’ðð0ð( ð ððB ðS ð¿Ëÿ ?ð     0 1 W Z :E ®óõY a > D       2 W Z 33333   1 3 C D D E Q Z    1 3 C D D E Q Z ÝzϬv¾xÿÿÿÿÿÿÿÿÿ>ÍPêf¨ÿÿÿÿÿÿÿÿÿse2&1¢ ÿÿÿÿÿÿÿÿÿ „˜þ„˜þƘþ^„˜þ`„˜þOJQJo(·ð„˜þ„˜þƘþ^„˜þ`„˜þo(. „‚„˜þÆ‚^„‚`„˜þOJQJo(.ÝzÏ>Íse2ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿå hú{?Ì]S  ÿ@€---Y à@ÿÿUnknownÿÿÿÿÿÿÿÿÿÿÿÿG�ÿ.à[xÀ ÿTimes New Roman5�€Symbol3.� ÿ.à[xÀ ÿAriale�€Monotype SortsSegoe UI SymbolC.,ÿ.ä{$À ÿCalibri Light7.�ÿ.ä{$À ÿCalibriA�ÿàÿ$BŸCambria Math#ñ€ðÐhß«¦Gß«¦G'›•†ñ ñ !ð¥À´´€20þ þ Kƒðßßÿÿ@P ðÿ $Päÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ h2!xx ûjß( ÜÿÿInitial Review ApplicationCSUWarren Sherman   þÿ à…ŸòùOh«‘+'³Ù0˜˜ ÄÐÜèô ( H T ` lx€ˆ�äInitial Review ApplicationÀ¶Ý®ÊÓÆµNormalWarren Sherman2Microsoft Office Word@Œ†G@’\Å@�Ñ­…Ø@�Ñ­…Øñ þÿ ÕÍÕœ.“—+,ù®0 hp”œ¤¬ ´¼ÄÌ Ô ûäÀ¶Ý®ÊÓÆµþ  Initial Review Application Title þÿÿÿ !"#$%&þÿÿÿ()*+,-.þÿÿÿ0123456þÿÿÿýÿÿÿ9þÿÿÿþÿÿÿþÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿRoot Entryÿÿÿÿÿÿÿÿ ÀF°LP×­…Ø;€1Tableÿÿÿÿÿÿÿÿû WordDocumentÿÿÿÿÿÿÿÿ8*SummaryInformation(ÿÿÿÿ'DocumentSummaryInformation8ÿÿÿÿÿÿÿÿÿÿÿÿ/CompObjÿÿÿÿÿÿÿÿÿÿÿÿrÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿþÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿþÿ ÿÿÿÿ ÀF Microsoft Word 97-2003 Document MSWordDocWord.Document.8ô9²q