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KAMAL AKHTAR
Background and Introduction
Paper based methods of data management involve more cost, effort and time.
The advent of PC based systems that can validate data has brought dramatic reduction in cost
and time.
A system that incorporates the capabilities of both front end and back end systems within its
framework hence providing data entry , medical coding, query management, auditing and data
analysis functionality dynamically within an integrated system can be called a CDMS.
Today most of the CDMS are huge complex centralized databases having a friendly front end
interface over the web.
A CLINICAL OVERVIEW
Origin of Data Management in Clinical Trials
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-Error prone -Different data standards
-Time consuming -Real time analysis not -Large cost on hardware
-Resource consuming possible -Networking issues for
multi centric trials
What is a CDMS?
Investigator
Relationship
Management
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IRB approval and decision status
What are the advantages of CDMS over legacy systems?
Weaknesses:
Advantages:
A TECHNICAL OVERVIEW
What are the CDISC data standards to be met by a CDMS?
ODM
Format for storage, exchange and archival
(Operational Data Model)
SDM
Format for submission of clinical data to FDA
(Submission Data Model)
-Provides metadata models
ADaM
-Analysis datasets to generate statistical
CDISC (Analysis Data Set Model)
results
Clinical Data Interchange
SEND
Standards Consortium Organization, structure an format for non-
Standard for the exchange
clinical data
of Non-Clinical Data
Standards for exchange, CRT-DDS -Data definition specification for CRT as XML
Storage, archival and Case Report Tabulation- - Enhances speed of processing by
Submission of clinical Data Definition Specification regulators
Data. -Also called define.xml
Lab Standard - Exchange of Lab data
-Still under development
Protocol Standard -To describe study protocol in machine
readable format.
-Allow automated database setup, computer
based workflows
DATA FLOW USING CDISC STANDARD
Patient Info
BRIDG
LAB
ODM A
SDM
LAB &
SDM
B
ODM
Define.xml
LAB,ODM,
Define.xml,
C
SDM
ADaM
LAB,ODM,
Define.xml, CDISC
D
ADaM, SDM Standard
PROTOCOL
ROADMAP TIMETABLE
What are the components of a CDMS?
CDMS
RDBMS Features/Tools
The RDC (Remote Data Capture) module is generally not a part of a CDMS with the exception of
Oracle Clinical.
For other systems the RDC and other third party applications have to be patched with the CDMS
using a specific Application Programming Interface (API) which depends on the architecture of
the CDMS.
CLINICAL DATA MANAGEMENT SYSTEMS
VENDORS
What are the types of CDMS used by Pharmaceutical companies?
In-House Systems
- These are systems that have been designed in-house
- Modules/applications can be modified as per need
- Have issues being regulatory compliant due to flexibility
-Relatively cheaper to develop
Vendor Systems
- These are CDMS designed by third part/company specifically to be licensed/sold to industry
players
- They have been validated as per regulatory guidelines (21 CFR Part 11 etc.)
- Modules/applications cannot be modified at the core but integrated using a validated API
- Very costly to implement
Oracle Clinical
Phase Forward
Siebel Clinical
eResearch Technology
MediData
NexTrials
ClinSource
What is the market share of various CDMS being used?
Market shares of the top 7 participants among the commercial, vendor supplied CDMS.
comprehensive solution
for management of
clinical data.
- RDC for entering and managing data from the investigator site.
ORACLE CLINICAL
(CDMS)
Clinical trials are set up and managed by Sponsor/CRO and site using Clinical Trial Minder and
Clinical Site Minder (CTMS)
TMS is the central coding system for both Oracle Clinical (CDMS) and Oracle AERS (Safety
System)
Oracle AERS pulls AEs and metadata from CDMS thus reducing reconciliation efforts.
The AERS reconciliation engine compares the CDMS and AERS and flags any differences in reports.
Oracle Clinical RDC can be said to be a different front end of Oracle Clinical. Data entered through
the RDC goes directly into the same tables as data entered from Oracle Clinical
Oracle Clinical and RDC use the same data definitions, screen layouts and edit checks.
Oracle
Site / Trial Minder
(CTMS)
Oracle
AERS Oracle AERS
Clinical Oracle Clinical
Reconciliation (Safety System)
RDC (CDMS)
Engine
Oracle TMS
(Dictionary Management)
Functionalities of SAS
Managing Reporting
Functionalities
Analyzing Reviewing
SAS/ACCESS Modules
SAS/STAT
Regulatory compliance