Electronic Monitoring Visit Report
Haversac® is designed by veteran Contract Research Associates (CRAs) that specialize in trial monitoring. They bring decades of practical field experience in CRF and eCRF deployment. Monitoring can account for 30% of a trial’s cost, so the Haversac Monitoring Tools are designed to ease, reduce, and speed up the monitoring tasks with some very unique features; of which only a few are described below:
1) Direct Reconciliation: The Haversac Global-Direct® pop-up window floats over the page and provides Haversac users with a menu list of the other “Global”, or “Core”, eCRF Events/Forms. This eliminates the need to toggle between pages to reconcile entries. Haversac Global-Direct® can be dragged, resized, opened and closed to fit each user’s needs.
2) Toggle Lists: Access each Global context list of events by selecting the side tabs.
3) Navigation to Global-Forms: A click here opens a Global-Form pop-up corresponding to the selected row.
4) Navigation to Global-Forms: Access a Global-Form by selecting its row.
5) Navigation to Linked Forms: Haversac® gives study designers the option of prompting data entry users to link one Form to another. In this AE Form example, data entry users are prompted to create a link to a related Medical History (MH) Form. Clicking this link opens the MH Form for review.
6) Navigate to linked Visit-Forms: This is a list of Visit-Forms that are linked to this AE. As described in 5 above, data entry users can be prompted to link Visit-Forms to Global-Forms. Linking prompts can be built into each Visit to ensure that Medical History, Adverse, Concomitant, Treatment, Drug Accountability, etc. events are being collected/performed, and so the Global-Form can be easily tracked to its origin. In this case, the user can go to the linked Visit-Form-Question by clicking the row.
7) Mark as Monitored: A Monitor can either monitor each question as necessary, or all of the Form’s qualifying data points at once. Each monitoring action and its method is recorded in the audit trail for review and reporting.