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7/21/2019 Clinical Data Management Overview-ACRI
http://slidepdf.com/reader/full/clinical-data-management-overview-acri 1/36
7/21/2019 Clinical Data Management Overview-ACRI
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CLINICAL DATA MANAGEMENT
Clinical Data Management is involvedin all aspects of processing the clinicaldata, working with a range of
compter applications, data!ases"stems to spport collection,cleaning and management of s!#ector trial data$
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% Clinical Data Management is the
collection,
integration and validation of clinicaltrial data
% Dring the clinical trial, theinvestigators collect data on thepatients& health for a de'ned timeperiod$ This data is sent to the trial
sponsor, who then anal"(es the)
Clinical Trial Data
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DATA MANAGEMENT WORKFLOW
Receipt of CRFs
(CRF Tracking/FilingFirst !ass
Entr"
#econ$ !ass
Entr" Clinical Data
Manage%ent
&atc'
ali$ation
T'esa)r)s
Man)al
Co$ing
Discrepanc"
Manage%ent
DCF
Resol)tions
#AE
Reconciliation*)alit" Control
!lanData+ase
Lock
A)to
Co$ing
Electronic
Arc'i,al
Data
Clarification
For%
(DCF
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WHY CDM
* +eview approval of new drgs !"+eglator" Agencies is dependent pon
a trst that clinical trials data presentedare of s-cient integrit" to ensrecon'dence in reslts conclsionspresented !" pharma compan"
* Important to o!taining that trst isadherence to .alit" standards
practices$
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/E0 MEME1E+23
The /e" mem!ersinvolved in DataManagement3
% Clinical Data Manager
% Data!ase Administrator
% Data!ase 4rogrammer
% Clinical DataCoordinator
% Clinical Data Associate
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Bigger Picture
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Clinical Trail Overview
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5
6$ Clinical Investigator
7$ 2ite coordinator
)$ 4harmacologist8$ Trialist9Methodologist
:$ 1iostatistician
;$ La! Coordinator
<$ +eference la!=$ 4ro#ect manager
5$ Clinical +esearch
Manager9Associate
6>$ Monitor
66$ +eglator" a?airs
12. Clinical Data
Management6)$ Clinical 2afet"
2rveillance Associate
@22A
68$ IT
6:$ IT9I2 personnel
6;$ Trial pharmacist
6<$ Clinical sppl"
6=$ Aditor9Compliance
MULTIDISCIPLINARY TEAMS INCLINICAL TRIALS
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+E24BN2I1ILITIE2 B CDM
Study Setup%C+ design and development@paper9eC+%Database built and testing
%Edit Checks preparation andtesting
Study Conduct%Data Entr"%Discrepanc" Management
%Data Coding @sing MED+A andFBDD dictionaries%Data review @Bngoing C%2AE +econciliation%Data Transfer
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Study Closeout%2AE +econciliation%alit" Control%Data!ase Lock%Electronic Archival
%Data!ase Transfer
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C+ DE2IGN9+EHIE
A representation of the std" as otlined in the protocol ismade @inclding C+ completion gidelines if necessar"$ Therefore a 'nal protocol needs to !e availa!le !efore thisactivit" can !e initiated$$ C+ design sall" takes a!otthree ronds3 irst draft @rogh withot detail !t correctcontent, second draft @as good as we can get it and 'nal
version$ e need inpt from or sponsor to correct draftversions and to approve the 'nal version$
% Traditional 4aper 1ased Case eport !orms%e"C! @Electronic Case +eport orm 2td" informationdirectl" entered into compter$%eC+ is prepared !" sing3%#$C%E C%&'&C$%%C%&'(&$%
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)aper C! e"C!
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FB MAN0 C+2 DB 0B NEEDJ
KEligi!ilit" or 2creening form
K4h"sical Eam form
KEnrollment form
KMedical Fistor" form
KAE form9 2AE form
KConcomitant therap" form
K1lood test form
KLa!orator" test form
Kollowp Hisit form
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DATA 1A2E DE2IGN
Data from a clinical trial will !ecollected and stored in some kindof compter s"stem$
A data!ase is simpl" a strctredset of data$
A collection of rows and colmns$
Ecel 2preadsheet
Bracle application
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D1M23M2 Access 4, M2 Ecel 4
Bracle ClinicalClintrial4haseforward Inormmedidata +ave
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C+ ANNBTATIBN
%An annotated C+ is generall" de'ned as a !lank C+ withmarkings, or annotations, that coordinate each data point inthe form with its corresponding dataset name$
%Essentiall", an annotated C+ commnicates where the datacollected for each .estion is stored in the data!ase$
%C+ Annotation is the 'rst step in translating the C+s into adata!ase application$
%CDM annotates the C+s !" esta!lishing varia!le names foreach item to !e entered$
%+eviewed !" CDM and 2tatistician
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HALIDATIBN CFEC/LI2T3
Halidation Checklist descri!es in detail which data shall!e checked and .eried if necessar"$ The programmingof the checks occrs according to this checklist$ 1eforethe programming starts, the sponsor will !e asked togive approval of this Halidation Checklist$
AT3 ser Acceptance Test Test s!#ects are entered in the data!ase to test the
entr" screens and the programming$ The eact nm!erof test s!#ects is not standard, !t ever" check has topass and fail @negative and positive proof at least
once$
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DATA1A2E 2ET 4 AND TE2TING
Data!ase setp and testing are alwa"s performed in a secre,non std" data environment$ Bnl" when a data!ase has!een reviewed and fll" tested, will it !e set in OprodctionP,a separate environment where onl" std" data will !eentered$ Changes in strctre or programming will alwa"s'rst !e performed and tested in the non std" dataenvironment !efore the" are made e?ective in theOprodctionP data!ase$
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CRF Tracking
Logistic wa" if it is paper !asedstd"$
EDCelectronic data captre if it iseC+$
Data EntryData entr" is a process of
entering9transferring data fromcase report form to Clinical Data
Management 2"stem @CDM2$
Data Entr"3 6 2ingle dataEntr"
7 Do!le Data Entr"
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DI2C+E4ANC0MANAGEMENT
Discrepanc" management is a process ofcleaning s!#ect data in the Clinical DataManagement 2"stem @CDM2, it incldes
manal checks and programmed checks$ Trivial discrepancies are closed as per selfevident correction method or niversal rlingand discrepancies which re.ire responsefrom the site are .eried !" raising DataClari'cation orms @DC$
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MEDICAL CBDING
The medical coding for a std" is done as
per the pro#ect speci'c protocol
re.irement$ The dictionaries sed for astd" are3
Adverse Events3 MedD+A @MedicalDictionar" for +eglator" Activities
Medications3 FBDD @orld FealthBrgani(ation Q Drg Dictionar"
Manal coding is performed sing ThesarsManagement 2"stem @TM2 which isintegrated with or Clinical Data
Management 2"stem @CDM2$
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2AE +ECBNCILIATIBN
* 2erios Adverse Event @2AE data reconciliation is thecomparison of ke" safet" data varia!les !etween Clinical
Data Management 2"stem @CDM2 and Master Drg2afet" Data!ase @MD2D$ +econciliation is performed toensre that events residing in !oth s"stems areconsistent$
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7<
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ALIT0CBNT+BL
* alit" 2hold !e maintained for overall std" !" performingalit" checks at intervals for all data points @Critical NonCritical prior to data!ase lock$
* C helps to ensre that all the data processed is accrate,clean and Correct$
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DATA1A2E LBC/
The data!ase lock for a std" is done
to ensre no maniplation of std"data dring the 'nal anal"sis$
Data!ase lock for a std" is done onceall data management activities arecompleted$ This incldes the data!ase
lock checklist which ensres the same$2ome of the activities inclded indata!ase lock checklist are Alldiscrepancies closed, DCs receivedand pdated, coding complete, 2AE+econciliation process complete etc$
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2-cientl" clean to spport statistical anal"sis, andits s!se.ent
presentation and CDM is a *ital *ehicle in Clinical(rials to ensure+
% The Integrit" .alit" of data !eing transferred from%trial s!#ects to a data!ase s"stem
% That the collected data is complete and accrate so
% that reslts are correct
% That trial data!ase is complete and accrate,% and a tre representation of what took place in trial
% That trial data!ase is s-nterpretation
OBJECTIVES OCDM
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CDM has evolved from a mere data entr" process to a mch
diverse process toda"
It provides data and data!ase in a sa!le format in a timel"manner
It ensres clean data and a Oread" to lockP data!ase
IMPORTANCE OCDM
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%CDM )ro,essionals+o 4harmacists
o Gradates94ost gradates in Life 2ciences, IT,2tatisticso Gradates with post gradation diploma in Clinical
+esearcho Licensed Medical 4ractitioners
%-tilie /uali0ed indi*iduals to+o 2pervise overall condct of trial @4ro#ect Manager
o To handle and verif" the data @Data Managero To condct the statistical anal"sis @1iostatistician)7
CDM PROESSIONALS
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Data Management ole in Clinical esearch+
DM ROLE IN CLINICAL
RESEARCH
% The data management fnction provides all data collectionand data validation for a clinical trial program
% Data management is essential to the overall clinical
research fnction, as its ke" delivera!le is the data to
spport the s!mission
% Assring the overall accrac" and integrit" of the clinical
trial data is the core !siness of the data management
fnction
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% Data management starts with the creation of the std"protocol
% At the std" level, data management ends when thedata!ase is locked and the Clinical 2td" +eport is 'nal
% At the compond level @of the drg, data management ends
when the s!mission package is assem!led and complete
DM ROLE IN CLINICAL RESEARCH
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MI22IBN B CDM
Consistency
$ccuracy
alidity
$rchi*ing
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