Data collection

Computerized data collection, also known as EDC (Electronic Data Capture) is the most important feature of eCRF. Indeed, without efficient data collection, it is understandable that your study will not advance.

Considering that for a long time, the screen capture of medical data was the main obstacle to the use of eCRF, we have paid particular attention to ergonomics to facilitate the data entry and to ensure that EOL© is compatible with all browsers.

Whether the Investigator passes through the Clinical Research Assistant (CRA) or Clinical Study Technician (CST), all input profiles are considered to accelerate the process of data collection.

Ergonomics of data entry:

• Cut out of eCRF in questionnaires, chapters, blocks, questions, sub-questions...;
• Conditional display based on previous responses;
• Conditional display based on the user profile, the stratum of the patient, the randomisation arm or specific conditions;
• Input help (Data documented by external links, attachments, comments);
• Browsing by page (Next - Previous) and tab (direct access to a page);
• Use of free text areas, check boxes, drop-down list, calendar for dates;
• Ability to import documents attached to the patient record (radiography, orders...);
• Precoding for Medrea bases.

Entry control:

• Automatic check for missing data;
• Automatic format check (Date, Num vs Alpha);
• Automatic check for off-limit data;
• Possible differentiation between unlikely (but possible) and impossible values;
• Possibility to enter partial dates;
• Check of coherence between variables of the same screen;
• Check of consistency between different questionnaires or visits;
• Check of AE/SAE, protocol deviation, inclusion error with sending of notification by email to the coordination team;
• Management of check box with configurable labels for no response justification (DM,ND,NA,UK,Not done, Don't know...) ;
• No blocking field to record its entry;
• Ability to define non-blocking mandatory fields;
• Possibility of partial records at any time;
• Any inconsistent, off-limit, or missing data generate a Query (request for correction) by a specific pictogram display next to the data and visible by the monitor.

Security and Audit Trail:

• Unique ID by user;
• Electronic signature;
• Automatic disconnection;
• Reminder for unsaved changes;
• Validation possible by the Principal Investigator;
• Traceability of all changes (Date/Time, User, Old and New value);
• Traceability of all actions (Connection, Registration, Validation, Disabling).

• Your project
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• Data collection
• Monitoring and validation
• Exporting to your tools

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EOL, the e-CRF solution

An e-CRF solution for the complete on-line management of clinical studies available on the Internet (tests, cohorts, health monitoring)

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