Study Definition
Data Entry
Data Entry via Electronic CRF Images
Integrated Forms Flow Management
Discrepancy Management
Dictionary Coding System
Clinical Data Review Tools
Regulatory Compliance
Electronic Submissions
Data Entry
16 types of data entry
Data keyed directly into SAS
®
datasets
Double-key entry (two operators enter data and discrepancies are resolved by Data Coordinator)
Data Entry by document ID number (accelerates second entry and corrections)
Dependent or independent verification
True row level locking for concurrent data entry (multiple users can enter data or browse the same table simultaneously).
Full Audit Trail (captures changes made to the database, reasons for the change, with a date/time stamp)
Browse or query data in case report form or table format
System manages Case Report Form Tabulations (CRT) tables in required SAS
®
format.
Data Clarification captured in database during entry.
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