Monitoring and validation

EOL© includes features for monitoring and for the validation of data entered to allow you to request correction and to monitor in real-time the progress of data entry and validation.

Audits and monitoring of data by the CRA:

• Management of multiple CRAs, each CRA can manage one or more centres;
• Identification of the Investigator who entered a particular data;
• Display of fill rate by folder, visits;
• Protocol deviation checks (Dates of visits, Criteria for inclusion, …);
• Sending emails to Investigators;
• Cancel or exclude patients with updating of the randomisation list;
• Track the number of questionnaires yet to be validated;
• Track the number of unsolved manual queries;
• Have the fill rate by questionnaire.

Managing requests for corrections:

• Pre-programmed data-management controls generate system queries; The CRA can issue manual queries and follow the correction;
• The CRA validates the data one by one, visit by visit, questionnaire by questionnaire;
• The CRA can only disable non-compliant data;
• Queries table listing all queries in progress or completed.

Global monitoring for the CRAs, Project Managers, Sponsors:

• Folders monitoring by questionnaire, visit;
• Folders monitoring by patient;
• Monitoring of the centres activity (open, active, number of inclusions ...);
• Monitoring of inclusions (inclusion curve, distribution by centre, by branches, layers);
• EIG monitoring (email and SMS alerts, reminders);
• Monitoring of lost to follow-up patients;
• Monitoring of missing data;
• Monitoring the rate of the filling in, by data, by centre;
• Table of queries (in progress, completed);
• Action to stop and restart inclusions;
• Freeze/unfreeze the database.

Audit Trail:

The Audit Trail makes possible to trace back all eCRF actions. This feature is available for CRAs, Project Managers, Sponsors. For the CRA this allows to trace back the data entry before, during and after any requests of corrections.
The Audit Trail is also evidence of actions such as registrations, validation, questionnaires disabling.

The Audit Trail includes: Centre No., Action, Patient No., Visit No., Value before, Value After, User name, Reason for the change, Time Stamp.

The Audit Trail is available for all Managers profiles.

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