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As soon as you click Abstraction Validation on the main menu, the system scans the abstracted information for errors and omissions automatically. You must correct all errors before completing the abstraction.

How to Validate Abstractions

  1. On the main menu, click Abstraction Validation

    The Abstraction Validation page appears. If the system does not find any errors, it displays “Abstraction is valid”. Otherwise, the system lists errors or omission. Instructions for correcting each error/omission are provided in the Comment column.

    The system lists error messages in the order in which they appear in the abstraction workflow. The workflow follows the order of features displayed in the main menu. For example, the system lists Administrative Abstraction errors before Scientific Abstraction errors; and General Trial Detail errors before Participating Sites errors.  

  2. If the Abstraction Validation page contains error/omission records, correct them according to the instructions in the Comment column and specific instructions included throughout this guide, and then proceed to the next step. For example, if validation failed due to Trial Status errors, navigate to the Administrative Data section on the main menu, click Trial Status, and then click Trial History to make the corrections.

  3. Optionally, if the Abstraction Validation page does not contain error/omission records, click View TSR or View XML to review the Trial Summary Report (TSR) or XML file.