CRF Design and Data Management - icssc

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4 Οκτ 2013 (πριν από 4 χρόνια και 1 μήνα)

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BioInformatics
BioInformatics
-
-
A Roadmap To Success
A Roadmap To Success
Data Quality Assurance Systems
Data Quality Assurance Systems
Patrick Murphy
Patrick Murphy
Director, Data Management
Director, Data Management
Family Health International
Family Health International
February 2004Family Health International
QA for Data Entry System
QA for Data Entry System


Data Entry System
Data Entry System


Annotated Case Report Forms
Annotated Case Report Forms


Record Layout
Record Layout


Data Dictionary
Data Dictionary


Validation
Validation


Audit trail
Audit trail
February 2004Family Health International
Annotated CRF
Prénom ___{PRENOM}________/ Nom _{NOM}____________/ N
o d’identification _____{ID}_____/ STDNO _{STDNO}/

Sex
e _{SEXE} Date de Naissanc
e{DDN}/ ____/_
___/

Poids __{P
OIDS}/ Nbre episode{NOT I
N DB}

Observations
J0 J1
J2
J3 J
J7 J
J14
Date
{DATEJ0}
{NIDB}
{NI
DB} {NI
DB}
{NIDB
} {NIDB}
{NI
DB}
{NIDB}
Temp. Axillaire
{TMP
J0}
{NIDB}
{NI
DB}
{TMPJ3}
{NIDB
}
{TMP
J7}
{NI
DB}
{TMPJ14}
Rate (0-5)
{RATEJ0}
{NI
DB}
{NI
DB}
{NI
DB}
{NIDB
}
{RATEJ7}
{NI
DB}
{RATEJ14}
ATCD fièvre 24 h
{NOT I
N DATA}
{NI
DB}

{NI
D
B}
{NI
DB}
{NIDB
}
{NIDB}
{NI
DB}
{NIDB}
ATCD Prise Med
lesquels à pr
eciser.
{NOT I
N DATA}
{NI
DB}

{NI
DB}
{NI
DB}
{NIDB
}
{NIDB}
{NI
DB}
{NIDB}
Céphalées {CEPH}
{NI
DB}
{NI
DB}
{NI
DB}
{NIDB
}
{NIDB}
{NI
DB}
{NIDB}
Dx Abdominales
{ABDX}
{NI
DB}
{NI
DB}
{NI
DB}
{NIDB}
{NIDB}
{NI
DB}
{NIDB}
Vomissem
ents {VOMIS}
{NI
DB}
{NI
DB}
{NI
DB}
{NIDB}
{NIDB}
{NI
DB}
{NIDB}
Asthénie
Marquée
{ASTH}
{NI
DB}
{NI
DB}
{NI
DB}
{NIDB
}
{NIDB}
{NI
DB}
{NIDB}
Troubles Resp.
{R
ESP}
{NI
DB}

{NI
DB}
{NI
DB}
{NIDB
}
{NIDB}
{NI
DB}
{NIDB}
Convulsions {CONVJ0}
{NI
DB}
{NI
DB}
{CONVJ3}
{NIDB}
{NIDB}
{NIDB}
{NIDB}
Pr
urit á la Chloroquine
{NOT I
N DATA}
{NI
DB}
{NI
D
B}
{NI
DB}
{NIDB
}
{NIDB}
{NI
DB}
{NIDB}
Coma (Score Molyn.)
{COMAJ0}
{NI
DB}
{NI
DB}
{COMAJ3}
{NIDB}
{NIDB}
{NI
DB}
{NIDB}
Aut
res signes/aff.
{NOT I
N DATA}
{NI
DB}
{NI
DB}
{NI
DB}
{NIDB
}
{NIDB}
{NI
DB}
{NIDB}
Traitement Antipalu.
(dose)
{TTTP} {NI
DB}
{NI
DB}
{NI
DB}
{NIDB
}
{NIDB}
{NI
DB}
{NIDB}
Traitement Concomit

A pr
eciser
les med
.
{TTTC}

{NI
DB} {NI
DB} {NI
DB}
{NIDB
} {NIDB}
{NI
DB}
{NIDB}
Hte en %
{HTEJ0}
{NI
DB}
{NI
DB}
{NI
DB}
{NIDB
}
{NIDB}
{NI
DB}
{HTEJ14}
Parasitémie

{PFJ0}
{PMJ0}
{POJ0}
{GAMJ0}
{NI
DB} {NI
D
B} {PFJ3}
{PMJ3}
{POJ3}
{GAMJ3}
{NIDB
} {PFJ7}
{PMJ7}
{POJ7}
{GAMJ
7}
{NI
DB}
{PFJ14}
{PMJ14}
{POJ14}
{GAMJ14}

February 2004Family Health International
Record Layout
RECORD LAYOUT

ADMISSION FORM
OCSADM

Ite
m #

Variable Nam
e
Data Ty
pe
Code Type
FSN


FORMTYPE


1 CN


2 STUDY


3 PN


4.1 ADMDATE
Date
(derived)

4.2 ADMDY


4.3 ADM
MO


4.4 ADM
YR


5 ADMIC


5.1 ADMICDAT


5.2 ADMICDY


5.3 ADMICMO


5.4 ADMICYR


6 ADMINC


7.1 ADMBDATE
Date
(deriv
ed
)

7.2 ADMBDY


7.3 ADMBMO


7.4 ADMBYR


8 ADMSTAT


9 ADMEDUC


10.1 ADMTOF


10.2 ADMWFF


10.3 ADMP
TF



10.4 ADMTOM


10.5 ADMWFM


10.6 ADMP
TM


11.1 ADMIUD


11.2 ADM
ORAL


11.3 ADMI
NJ


11.4 ADMIMP


11.5 ADM
DIA


11.6 ADMSPRN


11.7 ADMFCON


11.8 ADMCON


11.9 ADMW
RL


11.10 ADM
RTM


11.11 ADMLAC


11.12 ADMEC


11.13 ADMPREG


11.13
.1 ADMP
DATE
Date
(derived)

11.13
.2 ADMPDY


11.13
.3 ADMP
MO


11.13
.4 ADMPYR


11.14 ADMP
PART


February 2004Family Health International
Data Dictionary
February 2004Family Health International
Validation
Validation


Fill out CRFs with test data
Fill out CRFs with test data


Enter test data into data entry system
Enter test data into data entry system


Print out data from data entry system
Print out data from data entry system


Compare printouts to CRFs
Compare printouts to CRFs


File printouts for documentation
File printouts for documentation
February 2004Family Health International
Audit Trail
Audit Trail


When data is changed, save an electronic
When data is changed, save an electronic
record
record


Variable name
Variable name


Who changed data
Who changed data


Date of change
Date of change


Old value
Old value


New value
New value


Reason for change
Reason for change
February 2004Family Health International
QA for Data Sets
QA for Data Sets


Frequency on values
Frequency on values


Minimum/maximum values
Minimum/maximum values


Null/missing values
Null/missing values


Number of records in data set
Number of records in data set


Subject number ranges
Subject number ranges
February 2004Family Health International
Frequency on Values
Years

Of
Education
Fr
equenc
y
------
------- ------
--------
0
7
1
9
2
15
3
11
4
19
5
24
6
42
7
29
8
46
9
87
10

89
11

75
12

142
13

22

February 2004Family Health International
Minimum and Maximum Values .
14.9
7.7
Hbj28
15.1
7.2
Hbj21
15.7
7.5
Hbj14
15.1
6.1
Hbj7
15.8
6.7
Hbj0
80425
0
Pfj28
47975
0
Pfj21
42300
0
Pfj14
61250
0
Pfj7
475
0
Pfj3
432650
0
Pfj0
Maximum
Minimum
Variables
February 2004Family Health International
Missing data
170
164
130
WEIGHT
SUBJECT
February 2004Family Health International
Form Counts

STUDY_A F
or
m Counts

Form

Total Number of Forms in

Double Entry

Single Entry


ENROLL
676
676
0

EZADMF
657
547
110

EZADMM
655
547
108

EZAE
501
297
204

EZCM
613
402
211

EZCV
1,777
1,
254
523

EZEC
51
38
13

EZED
26
12
14

EZFINAL
257
117
140

EZGU
658
548
110

EZIEF
660
552
108

EZIEM
662
552
110

EZIH
PV

11
9
2

EZOB
G
659
548
111

EZPDAE
14
8
6

EZPHONE
216
114
102

EZPM
489
399
90

EZPQ
F
754
516
238

EZPQM
677
430
247

EZPREG
27
15
12

EZSI
147
54
93
Tot
al
10,186
7,634





2,
552

EZDIARY
Num
ber o
f subjects

444

Num
ber o
f
FSNs
7,894
Wednesday, August 30
, 20
00
Pa
ge 1 of 1
February 2004Family Health International
Subject Number Range
SUBJECT FREQUENCY
1001
2
1002
2
1003
1
1005
2
1006
1
1106
1
February 2004Family Health International
Data Quality Assurance System
Data Quality Assurance System
Conclusions
Conclusions


You must validate your systems
You must validate your systems


Documentation of systems is crucial
Documentation of systems is crucial


Retain testing records
Retain testing records


Simple statistical checks on data
Simple statistical checks on data


Look at your database from many angles
Look at your database from many angles