clinical srat presentation
TRANSCRIPT
CONFIDENTIAL 104/11/23
Clinical Trial Management & Clinical Data Management Systems
Technical/Strategic Part - 1
CONFIDENTIAL 204/11/23
CLINICAL DATA MANAGEMENT - INTEGRATION
LOCAL LAB/S DATA
SAS Drug Discovery(Operational Clinical
Database & Repository)
SAS Analytics(Tables, Listings &
Study Reports)
Medical Coding(MedDRA &WHODD)
Electronic transfer of Lab, ECG & Imaging
data per CDISCmodule
Electronic Data Capture
(EDC application)
TRIAL DATA
Web Access
Online real time access
through J-review
CDMSSubmissi
on by CDISC ADAM
Subm
issio
n by
CD
ISC S
DTM
CTMS(Planning, Recruitment, Budgeting & Tracking)
PROJECT MANAGEMENT
Aris/Argus Global(Pharmacovigilance)
DRUG SAFETY
IVRS
Crystal Reports/COGNOS/
INFORMATCA(Business Intelligence –Reporting)
Patient DiaryPaper/
Electronic/IVR
DATA
DSMB Reports
SMB Reports
CSMB Reports
CONFIDENTIAL 304/11/23
Clinical Data Management – Resources RequiredIn-house - CDM
DatacenterHw + Sw
SponsorEDC+SAS+Medra
+WHO+MeDra+Costat
Staff
Pharmaco. Sw/Tools
Regulatory Sw/Tools
Pr.Mgt.
In-house – CDM Staffing
• Program Manager
• Study Data Manager
• Content Writer
• CRF Builder
• CRF designer
• Database Programmer
• Data Validation Associates
• Statistical Analyst/Programmer
• Clinical Data Analyst
• Medical Coder
• AE Reporting Specialist
• Quality Assurance
CONFIDENTIAL 404/11/23
Clinical Data Management – Resources RequiredTechnology-Business Integration of CDM
DM SYSTEM
Sponsor EDC
Statistics
Pharmaco
Lab & External
Pr.Mgt.
Lab DataData Import to CDM Repository (Directory Structure)
SaS & SaS Tools
Imaging Data
Medical Coding
Data Import to SaS
Data Export from SaS
DatacenterDatacenter
Biomarkers & Others
Genetic Data
EDC SYSTEM
INTEGRATED DATA MANAGEMENT SYSTEM
CONFIDENTIAL 604/11/23
Clinical Data Management System/ProcessCTMSCTMS CDMSCDMS
SpectrumSpectrum
CDMS standardsCDMS standards
CRF dev. & ApprovalCRF dev. & Approval
DM Plan & ApprovalDM Plan & Approval
EDC Application dev. & Appr.EDC Application dev. & Appr.
Study db struct. dev. & approvalStudy db struct. dev. & approval
Validation Verification of CRFs & D.EntryValidation Verification of CRFs & D.Entry
Discrepancy resolution & managementDiscrepancy resolution & management
Electronic File Transmission & ManagementElectronic File Transmission & Management
Medical Coding & ApprovalMedical Coding & Approval
Reconciliation of AE’s & SAE’s Reconciliation of AE’s & SAE’s
Quality Evaluation of Study databaseQuality Evaluation of Study database
Study Db Lock Statistical Analysis & ReportingStudy Db Lock Statistical Analysis & Reporting
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CONFIDENTIAL 704/11/23
Clinical Trial Management System
Other Services
1. Clinical trial strategy and design development.2. Investigational plan creation.3. Analysis plan development.4. Investigator and site identification, recruitment, and
qualification.5. Study document development.6. Site initiation and training.7. Database development, including EDC options.8. Data and query management.9. CEC/DSMB management.10. Study monitoring.11. Site and sponsor auditing.13. Clinical report generation.14. Presentation and journal article preparation.15. SOP development.16. Comprehensive staff training.
CONFIDENTIAL 804/11/23
Technical overview of a Clinical Trial Management System
Application Back-end DatabaseDatamart, Datawarehouse
Digital Dashboard for Trial Managers
Business Intelligence Interface
Data
CONFIDENTIAL 904/11/23
Clinical Trial Management System/Software Integration with CDMS
CTMS Modules
• Project Mgmt.
• Budgeting & Finance
• Patient Management
• Investigator Mgmt.
• EC/IRB Approvals
• Compliance with FDA
• AE Reporting System
• eCTD (electronic Common Technical Document ) an interface for the pharmaceutical industry to agency transfer of regulatory information
CDM Modules
• Project Mgmt.
• EDC
• Pharmaco
• SAS
• Data Analytics
What is needed?A: Data integration with central lab, electronic patient diaries(ePro, IVRS, ECG and other third party applications and databases (including CDMS and CTMS) into one comprehensive software application
CONFIDENTIAL 1004/11/23
CTMS + CDMS + Pharmaco + Regulatory CDM + Pharmaco + Regulatory CTMS + Pharmaco + Regulatory
SpectrumPr.Mgt.
CTMS
Staff
DatacenterHw + Sw
SponsorEDC+SAS+Medra
+WHO+MeDra+Costat
Staff
Pharmaco. Sw/Tools
Regulatory Sw/Tools
Pr.Mgt.
1. Medical Monitor
2. Project manager
3. Chief Investigator
4. Principal Investigator
5. Clinical Research Coordinator
6. Clinical Research Associates
7. Associate Staff
CONFIDENTIAL 1104/11/23
1.1 CRF Design Specifications1.2 CRF Annotation Build1.3 CRF Database design build1.4 CRF Physical Screen Design1.5 CRF UAT Testing2.1 Edit Checks Specification2.2 Edit checks Specification programming2.3 Edit Checks UAT Testing2.4 Medical Coding Setup
DATA MANAGEMENT SERVICESFunctional
1.1 Lab Specifications1.2 Lab Specifications reconciliation checks1.3 Lab Reconciliations Checks programming1.4 Lab Reconciliations Checks programming UAT2.1 ECG Specifications2.2 ECG Specifications reconciliation checks2.3 ECG Checks Specification reconciliations checks programming2.4 ECG Checks Specification reconciliations checks programming UAT 3.1 Diary Specifications3.2 Diary Specifications reconciliation checks3.3 Diary Specifications reconciliation checks programming.3.4 Diary Specifications reconciliation checks programming UAT4.1 PK Specifications4.2 PK Specifications reconciliation checks 4.3 PK Specifications reconciliation checks programming4.4 PK Specifications reconciliation checks programming UAT
SET-UP ACTIVITIES
CRF
External
CONFIDENTIAL 1204/11/23
DATA MANAGEMENT SERVICES
1.1 Double Data Entry(Paper Only)1.2 External Data Vendor management1.3 Data Management Discrepancy Management1.4 SAE Reconciliation with Drug Safety / Pharmocovigilance1.5 Medical Coding [AE, Cocomitant Medication, Medical history]1.6 Investigator Discrepancy Data Management1.7 Monitors Discrepancy Data Management1.8 Clinical Review Discrepancy Management1.9 External Data Discrepany Management1.10 Clinical Review Report Management1.11 Data Mgmt. report Management1.12 Clinical/Data Mgmt. Metrics Report Management1.13 Statistical review Management
CONDUCT ACTIVITIES
DISCREPANCY MANAGEMENT(data entry/tracking, data cleaning, query resolution,
reconciliations, reviews etc.)
CONFIDENTIAL 1304/11/23
DATA MANAGEMENT SERVICES
1.1 Quality Assurance of Data [Error Rate]1.2 Patients Listings reconciliation including visits1.3 SAE Reconciliation1.4 Medical Coding1.5 All queries resolved1.6 All Data Discrepancies resolved1.7 Lab Data Reconciled1.8 ECG Data Reconciled1.9 Diary data reconciled1.10 PK Data Reconciled
CLOSEOUT ACTIVITIES
Data handling, reviews and QA, QC
CONFIDENTIAL 1404/11/23
DATA MANAGEMENT SERVICES
1.1 SAS dataset package/eCTD1.2 CRF data package/eCTD1.3 DM Document package/eCTD :
Data Management Plan Data Validation Plan CRF Completion guidelines CRF database annotations CRF Evident Corrections Self Checks Specification (CRF) Edit Checks Specifications (Lab, ECG, Diary, PK)
POST_LOCK ACTIVITIES
eCTD Management
THANK YOU
Satender SajwanGlobal Clinical Data Management / Integration Expert (Business)
Mobile: 732-910-9056