Clinical Data Management and E-clinical Trials (IPS)
-
Upload
api-3842711 -
Category
Documents
-
view
145 -
download
5
description
Transcript of Clinical Data Management and E-clinical Trials (IPS)
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