If you don’t have access to the following screens, please contact the Admin to get the appropriate access rights.
The monitor can access to the eCRF page history by clicking on the link located at the bottom of each page as shown below.
A pop up window is displayed with the full history of the actions made on the page.
In the table chart, you will see:
- Date – When the action on the page has been made
- Action – What kind of action has been performed (initial data entry, page completed, draft page, page monitored…)
- Comments – Any optional comments
- Realised by – Who made the specific action on the page
- Case owner – Who initially created the patient file
Once the page has been completed and signed by the investigator, the monitor can monitor the whole page data filling the specific « Area dedicated to monitor » displayed at the bottom of the page.
The monitor can define the monitoring status of the page, add a comment and sign the page.
The different monitoring status of the page are:
- Page monitored with remaining inconsistent data, expected correction : the page has been monitored but queries remained unsolved in the page. The investigator should correct the query in order to obtain the monitor validation of the page.
- Page accurate and freeze: the page has been successfully monitored without any queries detected. The monitor has validated and frozen the page for data entry.
- Remove monitoring status: the page has been successfully monitored and frozen. But afterwards the monitor has noticed an inconsistent data, he can then remove the monitoring validation of the page in order to create a new manual query.