Clinical data management and e-clinical trialsAn overview.

Research hypothesis

Protocol development

Subject enrollment

Site trial preparation

Data collection,Monitoring,processing,

Regulatory submission

Data analysis and reporting

Drug approval

Clinical research Cycle

What is clinical data management(CDM)The clinical data management is defined as a

planned process involving integrated methods for the management of the data captured during the clinical trial.

Comprises of Collection,Compilation and Validation of data so that it is suitable to prepare a report for obtaining the regulatory approval to market the drug.

Essential steps in CDM

CRFs entered

DATA BASE

CRF reviewed

CRF finalizedProtocolDesigned

Case report forms(CRF)

Designed

Source documents

Essential steps in CDM

Statistical analysis

Regulatory Submission

( with other data)

Data base locked updated

Data validation Data entry

into the data base

Queries raisedDiscrepancies

resolved

Clinical study reports

e-clinical trials

e-clinical trials

CDISC definition

Clinical Trial in which primarily electronic processes are used to plan, collect (acquire), access, exchange & archive data required for conduct, management, analysis & reporting of trial

Why e-Trials

Rapid access to Trial Data by all the

stake holders

Allows processes to be linked

Early Decisions as the data are

accessible easily

Reduces Cost

Reduce Time-to-market

Why e-Trials

reduces manpower

Stores large volumes of data

Automates tracking of processes

reduces chance of human error

Eliminates or simplifies steps in

process

e-trials application

Protocol development

Simulations of clinical trial design

protocol authoring

Site selection and preparation

Investigators/sites data base

Internet

IRB approvals electronically with e-signatures

Subject enrollment

Call CenterSubject Databases

Screening IVRS

Web-based program

Physician referrals to SMO

Retention & compliance programs

Collecting /acquiring the data

Electronic data capture methodsRemote data entryOMR/OCRInteractive voice response systemSemi-automated EDC (e-source

documentation and e-CRF(entry,review,editing,locking)

Clinical trial management

Status Reports

SAE tracking and AERS

Protocol Compliance/Protocol

Amendments

Clinical trial management

Analysis of project Metrics & ResultsTracking of data and meta dataProject management plans

monthly progress patient details patient procedures patient-reported adverse events

Analysis and reporting

SAS soft ware for analysis

Access data during trial

Data management

Regulatory submission

Templates

SAS transport files

e-CTD

e-clinical trials Standardize processes

Builds in the quality

Facilitate all the processes including monitoring,site

management, project management

Expedites regulatory approvals

Increases Productivity

Conclusion

Clinical research involves distinct areas of activity of which clinical data management forms an integral part

e-clinical trials streamline the complex process of

clinical trial by making the data accessible early in the process by all the participants of the trial.

The process is at infancy globally and needs to be implemented in a robust way for an effective outcome of clinical trial.

THANK YOU