CLINICAL DATA MANAGEMENT TRAINING
INTORDUCTION
- Overview Of Data Management
- Data Acquisition
CASE REPORT FORM
- CRF Desing And Development
- Electonic Data Capture
- Standard Operating Procedure
- Data Privacy
- Physical And Electronic Data Security
- Electronic Data Capture Principles
- Preparation And Preservation Of CRF
- Completion Guidelines
- CDM Presentation at investigator meetings
- Prepare SAS analysis
- datasets,tables,listings and figures as per specifications.
- Map and migrate legacy datasets into CDISC SDTM and ADaM standard datasets.
- Co-ordinate with the client and US-team for clarity of specifications,data issues,outlier etc
DATA STORAGE
- Physical Storge
DATA ARCHIVAL
- Database Validation ,Programming And Standards
- Data Entry And Data Processing
DATA CLEANING
DATA TRANSMISSION
DATA MANAGEMENT
- Dictonary Selection
- Auto-Encoder
- Safety Data Management And Reporting
- Serious Adverse Event Data Reconciliation
- Procedures
- Assuring Data Quality
- DATAbase Closure
- Recommende standard oerating procedures
- Clinical Data Archiving
- Vendor Evaluation
- Vendor Management
METRICS FOR CLINICAL TRIALS
- Data Management Metrics
- Cost
- Time
- Quality
- Audit Of Clinical Trails
Choosing An Auditor
- Planning The Audit
- Conducting The Audit
- Audit Checklist
- Chronology Lists
- Areas To Review
- Regulatory Documentation
- Clinical Documentation
- CRF And Sourse Documentation Consistency
- CRF Correlations
- ADE Documentationand Reporting
- Investigational Device Accountability Records
- Special Challenges For Auditors
- Using The Findings
- The Audit Report
GLOBAL ISSUES
- Introduction
- Principles
- Operational benefits of data interchange standards
- Scientific benefits of data interchange standards
- CDISC Standards
- ODM –Operational Data Model
SDTM
- ADaM–Analysis Dataset Model
- Lab –Clinical Laboratory Data Model
- Case Report Tabulation Data Definition Specificatio
- Protocol Representation Standard
- CDISC standards integration
CLINICAL TRIAL
- Responsibilities of Sponsor
- Post marketing surveillance
- 21 CFR PART 11
- Introduction
- Electronic Records
- Electronic Signatures
If you want to know more about Clinical Data Management Training do not hesitate to call +91-7774892805 or mail us on contact@intelogik.com
