Fillable Incident / Adverse Event Form (Samford University)

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Incident / Adverse Event Form (Samford University)

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Incident / Adverse Event Form
Instruct io ns :!Com plete!this!form!when!an!approved!human!subject!research!project!has!resulted!in!adverse!events!or!
reactions.!!Submit!this!form!to!the !Fac ulty!S po nso r!(if!app licab le).!It!is!the!resp on sibility!of!th e!fac ulty!sp o n so r!t o !su b mit!
the!adverse!ev en t!from !to!th e!IRB !chair!as!so on !as!p ossib le!after!th e!eve nt.!!If!there !is!no!facu lty!spo n sor,!the !princip al!
investiga to r!is !re sp o n sib le !fo r!s u bmitting!d ire ct ly!t o !th e!c u rre n t!IR B !C h air !as !so o n !a s!p o ss ib le !aft er !th e !ev ent.!
An!adverse!event!is!defined!as!any!unfavorable!and!unintended!accident,!diagnosis,!symptom,!sign!(including!an!
abnormal!laboratory!finding),!syndrome!or!disease!which!either!occurs!during!the!study,!having!been!absent!at!baseline,!
or,!if!present!at!baseline,!appears!to!worsen.!(NIH,!OHRP)!
PROJECT2TITLE:!
IRB!protocol!number:!! !Number!of!Subjects!Enrolled!to!Date:!!
PRINCIPAL2INVESTIGATOR(S):!!!
Phone:!! !Samford!email:!
FACULTY2SPONSOR2(if2applicable):!!
Department:!
Phone:!!! Samford!email:!
INCIDENT2REPORT:2
Date!&!Time!of!Incident:!
!Place!of!Incident:!
Affected!Subject!ID#/Initials:! !Age:! !Gender:!
Witness(es)!to!the!event:!
Date!&!Time!Sponsor!was!notified!(if!applicable):!
Date!&!Time!IRB!Chair!was!notified:!!
**Attach' a'detailed'description'of'the'adverse'even t.**'
A!Serious!adverse!event!is!defined!as!any!untoward!medical!occurrences!that:!result!in!death,!are!life!threatening,!
require!(or!p ro lo ng )!h os p ita liza tio n ,!cau se !pe rsis ten t!o r!sig nif ica n t!di sa bil ity/ inc a pa cit y,!resu lt!in !co n ge n ita l!an o m a lie s!or!
birth!defects,!or!are!other!conditions!which!in!the!judgment!of!the!investigators!represent!significant!hazards.!(NIH,!
OHRP)!!Is2this2a2Serious2adverse2event?!!!!
!Yes!!!!! No!!
An!unanticipated!a dverse!event!i s!defined !as!thos e!adverse!events! not!desc ribed!in !the!Package!I nsert,!Investi gator’s!
Brochure,!in!published!medical!literature,!in!the!protocol,!or!in!the!informed!consent!document.!(NIH,!OHRP)!!
Is2this2an2unanticipated2adverse2event?!!!!
!Yes!!!!! ! No!
An!Unrelated!adverse!event!is!clearly!due!to!extraneous!causes!(e.g.,!underlying!disease,!environment).!In2your2opinion2
was2this2adverse2event2related2to2the2intervention?!!!!
!Yes!!!!! ! No!
Did2the2participant2receive2medical/professional2treatment2related2to2this2event?! !Yes! !No!
If#Yes,#please#describe#in#detail:###
Does2the2participant2require2additional2medical/professional2treatment?! !Yes! !No!
If#Yes,#please#describe#in#detail:#
Will2the2participant2remain2in2the2study?!
!Yes !!!!!!No2
Is2the2event2likely2to2occur2again?!!!!
!Yes !!!!! No!
Provide#a#detailed#description#of#the#course#of#action/safeguards#that#will#be#implemented#to#en sure#this #does#not #
happen#again#(if#applicable):#
Has2this2same2type2of2event2occurred2previously2in2this2study?! !Yes! !No!
If#yes,#please#indicate#the#number#of#times:#
!No!
Is2the2event2adequately2described2in2the2protocol2and2consent2form?!!!!
!Yes!
If!no,!does!the!protocol/consent!form!need!to!be!modified?!!!!
!Yes!!!!! !No!
Please#explain#your#answer#in#detail:##
_____________________!_________________________________________________________________!
Date! Principal!Investigator!
_____________________!_________________________________________________________________!
Date! Faculty!Sponsor!(if!applicable)!
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Incident Adverse Event Form (Samford University)

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Completed 26 August 2020

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