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Part II

Defining Data Collection Objects

Part II describes creating data collection objects, data entry systems, and systems for testing data.

• Questions and Question Groups

• Global Library Activities

• DCMs and DCIs

• Defining DCI Books

• Annotating CRFs

• Creating Graphic Layouts

• Copy Groups

• Data Extract

• Lab Ranges

• Validation and Derivation Procedures

• Test Mode

• Integrating with a Clinical Trial Management System