Clinical Data Management Overview-ACRI

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$



% 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



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



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$



/E0 MEME1E+23

The /e" mem!ersinvolved in DataManagement3

% Clinical Data Manager

% Data!ase Administrator

% Data!ase 4rogrammer

% Clinical DataCoordinator

% Clinical Data Associate



Bigger Picture



Clinical Trail Overview



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



+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



Study Closeout%2AE +econciliation%alit" Control%Data!ase Lock%Electronic Archival

%Data!ase Transfer



67



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$%%C%&'(&$%



)aper C! e"C!



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



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



D1M23M2 Access 4, M2 Ecel 4

Bracle ClinicalClintrial4haseforward Inormmedidata +ave



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





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$



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$



77



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"



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$



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$



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$



7<



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$



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$2ome of the activities inclded indata!ase lock checklist are Alldiscrepancies closed, DCs receivedand pdated, coding complete, 2AE+econciliation process complete etc$



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



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



%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



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



% 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



MI22IBN B CDM

Consistency

$ccuracy

alidity

$rchi*ing



Documents

Clinical Data Management Overview-ACRI