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AIRTEL
e-CRF

Tracciabilità totale ed assoluta

Clinicians 'adopt' an e-CRF when this meets certain prerequisites, e.g. the input process does not require complex technicalities or more 'effort' than the minimum necessary for the input of the Experimental data.

Simple and intuitive interface

The Air-Tel e-CRFs have a very simple interface: the entry fields of the data are highlighted and ordered in intuitive lists.
All previous data are encapsulated in the background and can be modified in GCP.
Traceability is guaranteed. For data registration, pre-selected codes are used wherever possible (e.g. drop down menus, radio buttons to check) to minimize typing errors.




Guided Fill-in Routes
The forms which make up the case report are always visible on the menu bar but can only be opened following a non-intrusive guided fill-in route.
This procedure ensures that any data input finds an exact, unequivocal, correspondence reducing the number of consistency checks necessary to 'clean' the database.

Intelligent Management of the Units of Measurement (UM)
Each Centre can use its own UMs (provided by the laboratory) and need to enter it just once. The internal conversion tables can standardize the data 'on-the-spot' and allow statistical analysis in real-time even if the source Data are expressed in different units.

Data Entry Validity Check
Thanks to the UM conversion processes, each piece of lab data entered can be compared using a table containing a 'window' of plausible values. Gross mistakes are rejected by the system immediately, thus reducing the need to make 'obvious corrections'.



Centralised On-line Randomization
The randomizing software is always available online and connected to each e-CRF. When a patient is enrolled, the parameters collected during the screening process are used for the correct allocation, according to the protocol and by using minimization algorithms.

Real-time Statistics By Objectives
Detailed descriptive statistic forms enable the user to navigate the database by objectives rather than by patient. There are windows related to recruitment, violations, safety, concomitant pathologies, therapies.
Other windows are created according to the needs of each clinical study.



Coherence Controls
A powerful engine performs a series of coherence checks based on the specifics of each clinical study.
Succession and coherence of dates is highlighted on the pages that manage the access to the e-CRF of each patient.

Query Management
Any data item can be queried by means of a single click.
All queries are saved in the database and displayed both to the Clinicians and the Monitors. The system also includes an additional email notification system. Queries are answered by the Clinicians and are then closed by the Monitor.

Validation and Freeze of Each Form
Through a validation process, the update and/or modification of each form can be frozen by the monitoring staff to ensure the unalterability of the data up to that specific moment.

Powerful Monitoring Tools
For each centre most of the results of the previous functionalities are grouped and presented in summary tables. This enables the Monitor to be aware of the status, the validity and the coherence of the individual e-CRFs immediately and facilitate monitoring.



Safety and Integration Monitoring With Alerting Systems
All notified adverse events are processed in real-time. Reports and alerts are sent via email and/or text messages allowing full compliance with the pharmacovigilance laws in force.

Standard Data Format
All the clinical data can be exported, at any given time, in standard formats (access, excel, xml, csv) without service interruptions and can undergo standard protocol statistical analysis.

Multilingual instant change
With a simple mouse click, you can switch languages (up to ten) at any time, without having to logoff and login again.