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Features overview

General features

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Multilanguage

Interface can be rapidly translated to any language (only one language supports by one instance)

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Multiple version support

It is possible in the middle of a clinical trial to update the EDC system version without any difficulties. System update does not stop the data collection process

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SDTM mapping

Collected data can be mapped in accordance with SDTM to prepare them for subsequent electronic submission

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Data Export

Data are exported at any time in SAS-compartible format. Populated CRFs can be saved as PDF

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Training Mode

This mode allows users to create “mock” eCRFs, generate queries before real data will be entered

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Real-time notification

Any type of entered data can generate auto-notification to the e-mail of responsible person

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Randomisation

Any type of randomization can be set up before data collection is started

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Limits

You can set up patient limits to manage the amount of enrolled patients

eCRF features

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Data pre-validation

Before data is saved to the database, it is checked against applicable ranges. Invalid data will not be saved to DB

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AE/SAE reporting

Reporting form will notify the PV department via e-mail

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Query generation

In case of presence of questionable data, a CRA can generate queries and resolve them

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Calculated values

Some data points can be calculated automatically based on the previously entered data

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Audit trail

All corrected values save as well as reason and user who made editing

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Applicable ranges

For many type of data we indicate applicable ranges and data format. If data don’t match, they do not saved to DB

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Medical Coding

MedDra dictionary is integrated to code medical terminology

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System of Warnings

Unsuitable data in eCRF saved and highlighted for users. This helps to see questionable data and review it

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Digital Signature

Principal investigator can sign CRFs which have been populated and checked

Safety features

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Secured access

Only authorized person has access to data

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Secured data transfer

All data transmitted between the web server and browser remains encrypted

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Multilevel backup

All data are back up each two hours and we store 12 subsequent copies at a physically separated server

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Trustworthy hosting

OnlineCRF hosts at the servers which are located in Europe. Our cloud hosting provider serves Tesla, Slack and GitLab

User role settings

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Multiple users

System supports different roles: doctor, monitor, project manager, CTL and others

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Configurable roles

Users roles can be configured according to the needs of specific project and team

Project managment features

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Dashboard

Easily monitor the progress of study

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Verify and freeze

CRA can mark selected CRFs as verified and freeze them to avoid any uncontrolled changes

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RBM

OnlineCRF allows to identify “Risky” sites remotely and perform some corrective or preventive actions to avoid any uncontrolled changes

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Configurable reports

You can select any data set from the eCRF and upload it in the desired format. The report will contain only the data that you need without unnecessary information

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