Good Clinical Data Management Practices (GCDMP)

Theme : Good Clinical Data Management Practices

Dates : 5 March, 2010 - 23 July, 2010

Where : Faculty of Tropical Medicine, Bangkok, Thailand and Distance Learning (Online Class)

Contact E-mail : info@biophics.org

Contact Telephone : 662-354-9181 Fax : 662-354-9187

Organizer : BIOPHICS, Faculty of Tropical Medicine, Mahidol University

Co-organizer :

Instructor Biography

• Shannon Labout
• Kit Howard

Topics

• Data Management in Clinical Trial
• Data Acquisition / Data Privacy / Database Security
• Data Management Plan / Training
• CRF Design/ CRF Completion Guideline
• CDM Presentation at Investigator Meetings Vendor Management / CRF Printing and Vendor Selection
• Database Validation, Programming,and Strandards
• Edit Check Design Principles / Data Entry Processes
• QA / QC / Assuring Data Quality / Measuring Data Quality
• Laboratory Data Handling
• Medical Coding Dictionary Management and Maintenance
• Patient-Reported Outcomes
• Safety Data Management and Reporting/Serious Adverse Event Data Reconciliation
• External Data Transfers / Clinical Data Archiving / Data Storage
• Database Lock / Database Closure
• Electronic Data Capture - Concepts and Study Start-up
• Electronic Data Capture - Study Conduct
• Electronic Data Capture - Study Closeout
• Computer Validation (Computerize System in Clinical Trial)
• Data Management Standards in Clinical Research
• Metrics for Clinical Trials

Training Schedule