Test/Production mode setting is a crucial feature designed to ensure that electronic Case Report Forms (eCRFs) and electronic Patient Reported Outcomes (ePROs) are thoroughly tested and validated before they are used in live studies.

Test Mode Purpose

Test mode is specifically designed to facilitate the development, editing, and testing of eCRFs and ePROs within EasyMedStat. This mode allows users to experiment with different configurations, question types, and validations without affecting real patient data. It is an essential phase where researchers and clinical project managers can ensure that the forms meet the study's requirements and are user-friendly for both clinicians and patients.

By default, the test mode is activated on any new eCRF.

Transitioning to Production Mode

Production mode should be activated only when all tests have been completed and the eCRFs and ePROs are finalized. This transition is a critical step, signifying that the forms are ready for actual data collection and the study is moving into its operational phase.

Before the Transition

- Complete All Tests: Ensure that all testing scenarios have been covered, and the forms accurately capture the required data without errors.

- Stakeholder Approval: It is recommended to obtain final approval from all key stakeholders, including principal investigators, data managers, and IT security teams, to confirm that the eCRFs and ePROs meet the study's needs.

Transition Process:

You can switch the series from Test mode to Production mode in the menu Series > Settings.

- Resetting Data: Upon transitioning to Production mode, users have the option to reset the list of patients and the counters of Patient IDs. This step ensures that test data are cleared, and the system is ready for clean data capture.

- Irreversible Action: Moving to Production mode is a permanent action that cannot be reversed. 

- Audit Trail: The transition to Production mode is logged in the system's audit trail, providing a transparent record of the study's progression from testing to data collection. This feature supports compliance with regulatory requirements, ensuring that all actions are traceable and accountable. All patient-related audit trails are deleted if the patients are deleted during the transition to Production mode.

Best Practices and Considerations

- Thorough Testing: Extensively test the eCRFs and ePROs in Test mode to minimize the need for amendments once in Production mode.

- Data Backup: Before transitioning to Production mode, consider backing up the test data for reference, especially if it includes valuable insights for form design or study planning.

- Training: Ensure that all users involved in data entry and management are trained on the finalized forms and understand the importance of accuracy and adherence to study protocols.