6. CDM Process Database design Protocol Review & CRF Design/Review Development Stage Data validation program Data entry application Pre-entry review Double data entry Data Processing Stage Unmatched check Logical check Discrepancies mgt. Closing Stage Medical coding DB lock Validation of SAS data set Transformation to SAS data CRFs management
7. CDM Flowchart Data Entry Approved Blank CRF and Protocol Quality Control of Database and Database go live Batch Validation Medical Coding QA/QC of data CRF Annotation, Edit Specification Document Preparation Database Lock & Statistical report generation Database Design Setup Test Data Entry CRF’s completed at site. CRF Receipt and Tracking in Data Center Maintaining Missing & pending pages log Discrepancy Mgt. Pre-Data Entry Review
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9. Why discrepancy? Data complete? Data consistent? Discrepancy Data correct? Data logical? Data legible?
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20. CTCAE Codes for Abnormal Lab Results QTc >=501 or >60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia Grade 4 Death QTc >=501 msec on at least two separate EKGs QTc 481 - 500 msec QTc 450 - 470 msec Prolonged QTc interval Grade 5 Grade 3 Grade 2 Grade 1 CTCAE v3.0 Term
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