introduction to cdm i

7/31/2019 Introduction to CDM I

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Introduction to CDM - I


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Objective

What is data management

Data in Clinical trial : What is data ;Whocollects; From where

CRF work flow: Paper CRF and eCRF

Data Management Plan

CRF Data Check

Data Acquisition to CDMS

Data Base Designing


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What is data management?

Clinical Data Management is the technology andprocesses that manage clinical data to produce ahigh quality, clean and analyzable database.

Elements of Data Management:

Data Management Plan, CRF Processing/Filing,

Data Entry, Validation (Query Generation),Query Management, Coding, Quality Checks,Audits.


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What are data?

Information (Facts/Figures)

An accounting of the study


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Who can collect the data?

Investigators

Nurses

Research Team Subject

Subjects family

Subject's own Physician


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Where is the data?

In the source documents.


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What is a source document?

It is the first recording

What does it tell? It is the data that document the trial

The study was conducted according to the

protocol.


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Source Documents

Original Lab reports

Surgical reports

Physicians progress report Nurse report

Medical record

Letters from referring physician Original radiological films


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Source Documents

Tumor measurement

Patient dairy/Patient information


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What do you collect?

Demographical data

Eligibility

Study Agent Concurrent Therapy

Assessments/tests/exam

Adverse Events Response according to protocol


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Conduct of the trial

Data collection

CRF scanning &

Indexing

Data entry

Data review &

Discrepancy

management

Data base Lock

Analysis and

Clinical Study

Report

Regulatory

submission


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Protocol

Data management

Plan

CRF Design

Clinical Database

Design


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Receive CRF

CRF Work Flow

Track CRF PagesCreate CRF

Inventory

Data Processing Data ValidationIssue

IdentificationMakeQuery

DCF to siteResolved DCFreceived

Data BaseUpdated

QC ofUpdate

Audit TrialUpdated

Coding Validation QC audit

Clean Data


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E D C

DataReceived

Receipt of QC ValidationIssue

IdentificationMake query

DQF to siteResolved

DQFReceived

DatabaseUpdated

QC of Update

Audit trailupdated Coding Validation

QC Audit


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Manage the data collection

Set up plan

Plan CRF to capture the needed data

Collect data as it happens Standardize data entry procedure


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Data management Plan is the plan for studyspecific Data Management Process. It serves asthe backbone of overall quality system of Data

Management.



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What is the work to be performed?

Who is responsible for the work?

Which SOP or guidelines will apply?Which documentation or output to collect or

produce?

What level of quality should be achieved?


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Elements of Data Management

Study set up

Designing CRF

Track CRF

Entering Data Managing Lab Data

Identifying and managing discrepancies Collecting Adverse event data

Coding reported terms Data base lock Creating reports and transferring data


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Data Management Tool

Case Report Forms

Common data elements

Electronic Data CaptureAudits


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CRF Data Checks

Missing Data

Incomplete data

Illegible data Inconsistent data

incorrect data

Questionable data


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Data Acquisition

Single data entry

Double data entry

Remote data entry Optical character recognition

Optical Mark Recognition

Web site entry


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Data Base development and

validation

Objective

Design, generate and validate a data base

Scope

Data base development for all clinical protocol


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Responsibility

Design and generate a database

Accurate

CRF Computer

Validation

Data Base Statistical AnalyzedRetrieval Report


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Data base Designing

Plan the way the data is to be structured

Data sets defined and coded with alpha numericcodes

These codes are annotated to the blank CRF

Based on the protocol requirements the

validation rules are createdA validation plan is written and reviewed by the

QC group and the Statistician


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Essential characters of data base

Security

Audit trails

Null values (unk; n/d; n/a) InBuilt data validation


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Introduction to Clinical Data ManagementII

(to be continued)