ࡱ> FHE +bjbjޥ a2ǴǴ3,oHH$Pf,4Z RT0Tm1d$!^$]@0 MMMR80MMM:,A0`8 B\7- }* 0Z 7 %%A%A<MMZ %H h: MSU USE ONLY IRB Log No.: ________________ MSU Proposal No:_____________ Institutional Review Board (IRB) ſ Adverse Event Reporting Form  I Principal Investigators Name: FORMTEXT       IRB Protocol Number: FORMTEXT       Project Title: FORMTEXT       Event Date:  FORMTEXT       Was an Adverse Event form completed for another organization:  FORMCHECKBOX  Yes  FORMCHECKBOX  No (If yes, attach a copy to this form) Summary of event: FORMTEXT       Outcome of event: FORMTEXT       Was this a routine expected outcome?  FORMCHECKBOX  Yes  FORMCHECKBOX  No Was this risk listed in consent form?  FORMCHECKBOX Yes  FORMCHECKBOX  No Severity of Event:  FORMCHECKBOX  Mild  FORMCHECKBOX  Moderate  FORMCHECKBOX  Severe  FORMCHECKBOX  Life Threatening  FORMCHECKBOX  Fatal Is this event related to the research?  FORMCHECKBOX  Related  FORMCHECKBOX  Possibly Related  FORMCHECKBOX  Not Related  FORMCHECKBOX  Probably Not Related  FORMCHECKBOX  Not Enough Information to Judge If Related or Possibly Related, what procedures were in place to minimize or reduce this risk? FORMTEXT       Cause of event if not related to research: FORMTEXT       SIGNATURES: I certify that to the best of my knowledge the information presented herein is an accurate reflection of the adverse event. Faculty Research _______________________________________________ _______________________________ Faculty Name Date _________________________________________________________ ______________________________________ Implementor Present During Adverse Event Date Student Research _______________________________________________ ________________________________ Faculty Sponsor Date _______________________________________________ ________________________________ Student Researcher Date _______________________________________________ ________________________________ Implementor Present During the Adverse Event Date Witness _______________________________________________ ________________________________ Witness Name Date Address: Telephone: FOR IRB USE ONLY Signatures below certify review of this report. ______________________ ______________ IRB Chair Date ______________________ ______________ IRB Vice Chair Date ______________________ ______________ IRB Administrator Date ______________________ ______________ IRB Member Date ______________________ ______________ IRB Member Date ______________________ ______________ IRB Member Date ______________________ ______________ IRB Member Date ______________________ ______________ IRB Member Date ______________________ ______________ IRB Member Date  Are there prior reports of similar events: ( Yes ( No Should protocol be revised? ( Yes ( No Should consent form be revised to inform future   *EFcef  6 8 L N P Z \ z | ʷ¯򘥈{nj\h9LCJUjh9LCJUjh9LCJUmHnHujth9LCJUjh9LCJUjhh)Ujh9LUjh9LUh9Ljhh)CJUmHnHu hh)CJ hh)5CJ h9L>*CJ h9LCJ h9L5CJ+ef ^  &dP$a$$p^p`a$gdh)$^`a$gdh)-n &$d%d&d'd+DNOPQ d f 2 4 H J X | ~   " $ . 0 L N P ~jh9LCJUjh9LCJUjh9LCJUj0h9LCJUjh9LCJU h9L6CJjFh9LCJUjh9LCJU h9LCJjh9LCJUjh9LCJUmHnHu, Z X Z GDFWovh`h & F &dP &d P  "#123>?MNO]^lmnxy()789GHVzjh9LCJUj.h9LCJUjh9LCJUjDh9LCJUjh9LCJUj\h9LCJUjh9LCJUjth9LCJU h9LCJjh9LCJUjh9LCJU-VWXpq246@BW&x"#3p(((!("(N(O(T(U(⠙♠⸤⠒U jh9L h9L6CJh9L h9L5CJjz h9LCJUjh9LCJUmHnHuj h9LCJUj h9LCJU h9LCJjh9LCJUj h9LCJU8&'xT"defh^h?QRx#56\np&('(Y(Z(subjects of this event? ( Yes ( No Should all study subjects be informed? ( Yes ( No Revised consent form submitted? ( Yes ( Not Applicable Initial Review:_____________________________________ Initial Action:_____________________________________ _________________________________________________ _________________________________________________ ( Copy to Attorney ( Copy to Provost Final Action:_______________________________________ __________________________________________________ __________________________________________     IRB Adverse Event ( July 2002 Adverse Event: Any happening not consistent with routine expected outcomes that results in bodily injury and/or psychological, emotional, or physical harm or stress. This completed and signed form must be submitted as a pdf document to the IRB at  HYPERLINK "mailto:msu.irb@murraystate.edu" msu.irb@murraystate.edu within 3 calendar days of the adverse event. 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