Template CaseReportForm ORHv1

Study Code: Randomisation no: Subject initials:
This Example CRF can be used as a starting point for designing a study specific CRF. The
CRF should include all data which the protocol states will be collected.
CASE REPORT FORM
STUDY TITE
Inse!t b!ie" title
Study !e"e!ence numbe!
inse!t
CI#ICA TRIA SITE$U#IT:
PRI#CIPA I#%ESTI&ATOR:
Subject Initials:
Subject Randomisation #umbe!:
I am confident that the information supplied in this case record form is complete and
accurate data. I confirm that the study was conducted in accordance with the protocol
and any protocol amendments and that written informed consent was obtained prior to
the study.
Investigators Signature:
Date of signature:
D d m m m y y y y
Version no.: insert
Date: insert
Inclusion C!ite!ia Yes #o'
( Is the subject a healthy male aged between 18 and 60 years
) !as the subject willingly given written informed consent
*
+
,
"If any inclusion criteria are tic#ed no then the $atient is not eligible for the study%
E-clusion C!ite!ia Yes' #o
(
)
*
+
,
.
/
0
1
" If any e&clusion criteria are tic#ed yes then the $atient is not eligible for the study%
'age (
%ISIT ( 2SCREE#I#&3
Date: _______________
DD MMM YYYY
I#FORMED CO#SE#T
'lease note: written informed consent must be given before any study s$ecific $rocedures ta#e
$lace or any current thera$y is discontinued for the $ur$oses of $artici$ation in this study%
!as the subject freely given written informed consent )es o
DEMO&RAP4IC DATA
*ge +yrs,: Se&: -emale .ale
!eight +m,:

/eight +0g,:

1ody .ass Inde& +1.I 2 /t +#g,3!
(
+.,:

SMO5I#& 4A6ITS
Does the subject smo#e or use tobacco $roducts ")es 4o
' !ow many cigarettes $er day
5ther6 s$ecify
77777777777777777777777777777777777777777777777777777777777777
ACO4O CO#SUMPTIO#
Does the subject consume alcohol )es 4o
If yes6 how many units $er wee#
MEDICATIO#S TA5E#
Is the subject currently or $reviously ta#ing any medication including 5896 vitamins and3or
su$$lements )es 4o
":ecord all medication on 9oncomitant .edications $age
'age ;
%ISIT ( 2SCREE#I#&3
PRE%IOUS MEDICA 4ISTORY
Is there any relevant medical history in the following systems?
9ode System ")es 4o 9ode System ")es 4o
1 9ardiovascular < 4eo$lasia
( :es$iratory 10 4eurological
; !e$ato7biliary 11 'sychological
= >astro7intestinal 1( Immunological
? >enito7urinary 1; Dermatological
6 @ndocrine 1= *llergies
A !aematological 1? @yes6 ear6 nose6 throat
8 .usculo7s#eletal 00 5ther
!"f YES for any of the abo#e$ enter the code for each condition in the boxes below$ gi#e
further details %including dates& and state if the condition is currently or potentially
acti#e. "f gi#ing details of surgery please specify the underlying cause. 'se a separate
line for each condition.
Cu!!ently Acti7e8
Code Details (including dates) Yes No
'age =
%ISIT ( 2SCREE#I#&3
P4YSICA E9AMI#ATIO# 2to be ca!!ied out by medical sta"" only3
Code System 'Abno!mal #o!mal
1 >eneral *$$earance
( !eart
; Bungs
= *bdomen
? @&tremities
" If ABNORMAL enter the code for each condition in the bo&es below and give brief details%
'lease use a se$arate line for each condition%
Code Details
%ITA SI&#S
'ulse rate
1$m
1lood $ressure +seated, / mm!g
EC&
Is the @9>: 4ormal *bnormal
!!Description
:
____________________________________________________________
:etain signed and dated trace in the $lastic sleeve at bac# of 9:-
'age ?
%ISIT ( 2SCREE#I#&3
A6ORATORY A#AYSIS Initials
1lood for haematology and biochemistry
8a#en by
!e"eat #am"le !e$uired? Date %a&en (dd mmm yyyy)
!aematology
9linical 9hemistry
Please inse!t a co:y o" all !esults in t;e :lastic slee7e at t;e bac< o" t;e CRF=
A!e all "inal !esults: 4ormal *bnormal 49S
""*bnormal 9S
!!Description
:
Does any result contradict study entry
")es
4o
Initials:
"If )@S6 subject must not continue% 'lease com$lete off study $age%
Add Study S:eci"ic Data> as !ele7ant "o! t;e :a!ticula! study
'age 6
%ISIT ( 2SCREE#I#&3

End o" %isit C;ec<list: to be com:leted by In7esti?ato!
Yes #o
1 Does the subject satisfy the inclusion and e&clusion criteria to date
( !ave all screening $rocedures been com$leted
; !as the concomitant medication $age been com$leted
= Is the subject willing to $roceed
In7esti?ato!
Yes #o
Is the subject to continue
!as medication been collected from 'harmacy
!ave the dosing instructions been e&$lained to the $atient
Signature: Date:
d d m m m y y y y
If CYes $lease:
9om$lete details of ne&t visit and any other needed instructions on the instruction card%
>ive the subject the instruction card
'age A
%ISIT ) 2@EE5 (3 Date:______________
DD MMM YYYY
( !eart
; Bungs
= *bdomen
? @&tremities
' I" any c;an?es "!om baseline> com:lete ad7e!se e7ent :a?e=
%ITA SI&#S
'ulse rate
1$m
1lood for haematology and biochemistry 8a#en by
Re:eat Sam:le ReAui!ed8 Date Ta<en 2dd mmm yyyy3
!aematology
9linical 9hemistry
""*bnormal 9S
!!Description
:
Does any result contradict continuation in the study
")es
4o
'age 8
%ISIT * 2@EE5 ).3 Date:______________
DD MMM YYYY
( !eart
; Bungs
= *bdomen
? @&tremities
%ITA SI&#S
'ulse rate
1$m
!aematology
9linical 9hemistry
""*bnormal 9S
!!Description
:
")es
4o
'age <
%ISIT + 2@EE5 ,)3 Date:______________
DD MMM YYYY
( !eart
; Bungs
= *bdomen
? @&tremities
%ITA SI&#S
'ulse rate
1$m
!aematology
9linical 9hemistry
""*bnormal 9S
!!Description
:
")es
4o
'age 10
%ISIT , 2@EE5 ,.3 Date:______________
DD MMM YYYY
( !eart
; Bungs
= *bdomen
? @&tremities
%ITA SI&#S
'ulse rate
1$m
1lood for DE@s 8a#en by
9linical 9hemistry
""*bnormal 9S
!!Description
:
!as renal function remained stable )es
"4o
"If 4o6 record on adverse event $age%
'age 11
C'NC'MI%(N% M)DIC(%I'N#
'age 1(
(edication
Total
Daily
Dose
'nits Reason
)tart Date
(MM/DD/YYYY)
)top Date
(MM/DD/YYYY)
C
o
n
t
i
n
u
i
n
g
*** *** + *** *** + *** *** *** *** *** *** + *** *** + *** *** *** ***
*** *** + *** *** + *** *** *** *** *** *** + *** *** + *** *** *** ***
*** *** + *** *** + *** *** *** *** *** *** + *** *** + *** *** *** ***
*** *** + *** *** + *** *** *** *** *** *** + *** *** + *** *** *** ***
*** *** + *** *** + *** *** *** *** *** *** + *** *** + *** *** *** ***
*** *** + *** *** + *** *** *** *** *** *** + *** *** + *** *** *** ***
*** *** + *** *** + *** *** *** *** *** *** + *** *** + *** *** *** ***
*** *** + *** *** + *** *** *** *** *** *** + *** *** + *** *** *** ***
*** *** + *** *** + *** *** *** *** *** *** + *** *** + *** *** *** ***
Ad7e!se E7ents
!as the $atient e&$erienced any *dverse @vents since signing the Informed 9onsent )es6 s$ecify below 4o
AE
no=
Ad7e!se E7ent +diagnosis +if #nown, or
signs3sym$toms,
Sta!t Date
dd3mmm3yyyy
and Time
+(= hour
cloc#,
Sto: Date
dd3mmm3yyyy
and Time
+(= hour
cloc#,
Outcome
12:ecovered
(2:ecovered
with seFuelae
;29ontinuing
=2'atient Died
?29hange in *@
62un#nown
Se7e!ity
12.ild
(2.oderate
;2Severe
Plausible
!elations;i:
to Study D!u?
Action ta<en Bit;
Study D!u?
124one
(2Dose :eduction
8em$orarily
;2Dose :educed
=2Discontinued
8em$orarily
?2Discontinued
@it;d!aBn
due to AE8
Se!ious AE
2SAE38
I" SAE does it
!eAui!e
immediate
!e:o!tin?8 2see
P!otocol38
3 3 3 3 )es )es )es )es
: : 4o 4o 4o 4o
3 3 3 3 )es )es )es )es
: : 4o 4o 4o 4o
3 3 3 3 )es )es )es )es
: : 4o 4o 4o 4o

'age 1;
'** #%+DY *'!M
Date ,ff )tudy: *** *** + *** *** + *** *** *** ***
(MM/DD/YYYY)
Date -ast )tudy (edication Ta.en: *** *** + *** *** + *** *** *** ***
(MM/DD/YYYY)
!eason 'ff #tudy %/lease mar. only the primary reason. Reasons other than Com"leted #tudy re0uire
explanation next to the response&
Completed study
1E+)1E (com"lete () C!* , #() form- if a""lica.le) _________________________________________________________________
-ost to follow2up ***********************************************************************************************
on2compliant participant *************************************************************************************
Concomitant medication **************************************************************************************
(edical contraindication**************************************************************************************
3ithdraw consent *********************************************************************************************
Death (com"lete #() form) __********************************************************************
,ther **********************************************************************************************************
'age 1=

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Study Code: Randomisation no: Subject initials:

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