With the Monitor and Manage Data module in OpenClinica, you can oversee and validate data for a Study, allowing for increased productivity in clinical trials management. Access to the features in the module depends on your User Role: see Monitor and Manage Data – Permissions.

The module consists of the following features:

  • Source Data Verification: When you review the conformity of data in CRFs and for Study Subjects, you can use Source Data Verification to track your evaluations, helping to ensure the Study is complete, accurate, and verifiable.
  • Study Audit Log: You can view the change history for each Study Subject in log format and use it to facilitate the validation process of a Study.
  • Subject Matrix: You can view information about each Subject in the Study or Site from the Subject matrix
  • View Events: You can view information about any Study Event.
  • Notes and Discrepancies: Use Notes and Discrepancies for query and discrepancy management capabilities to help you verify the accuracy and completeness of data in a clinical trial.
  • Rules: Use these tools to validate data entry for CRFs, test specific rule action, and perform cross-field and cross-form edit checks. Rules in OpenClinica are flexible and easy to define, run, and reuse. For details, see the Rules chapter.
  • Groups: Use Subject Group Classes to categorize Subjects within a Study, such as for treatment options. There can be multiple Group Classes within a Study.
  • Manage CRFs: View all case report forms (CRFs) for a Study, create new CRFs, or create new versions of existing CRFs.