Clinical Data Management And E-clinical Trials (ips)

Clinical data management and e-clinical trials An overview.

Drug approval

Research hypothesis

Protocol development

Clinical research Cycle

Site trial preparation Subject enrollment

Regulatory submission Data analysis and reporting

Data collection, Monitoring,processing,

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 Protocol Designed

Case report forms (CRF) Designed

CRF finalized

DATA BASE

Source documents

CRFs entered

CRF reviewed

Essential steps in CDM Data entry into the data base

Queries raised Discrepancies resolved

Data validation

Regulatory Submission ( with other data)

Clinical study reports

Statistical analysis

Data base locked updated

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 Reduce

Cost

Time-to-market

Why e-Trials 

reduces manpower

Stores

large volumes of data

Automates reduces

chance of human error

Eliminates

process

tracking of processes

or simplifies steps in

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 esignatures

Subject enrollment Call

Center Subject Databases Screening

IVRS

Web-based

program

Physician

referrals to SMO

Retention

& compliance programs

Collecting /acquiring the data Electronic data capture methods Remote

data entry

OMR/OCR Interactive

voice response system

Semi-automated

EDC (e-source documentation and eCRF(entry,review,editing,locking)

Clinical trial management Status SAE

Reports

tracking and AERS

Protocol

Compliance/Protocol

Amendments

Clinical trial management Analysis

of project Metrics & Results

Tracking

of data and meta data

Project

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  Builds

processes

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.

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