Main Features

ECRF is an electronic form for collecting relevant information in a clinical trial to achieve the objective of this trial. Its content is described by the protocol. Its access is nominative and protected by a password.

  • Users profiles

    Profiles and user rights

    Several types of users (profiles) are brought to use the platform of eCRF.
    Each profile has its own rights.

    Examples of profiles

    • Promotor
    • Principal investigator
    • Sub-investigator
    • CRA

    Examples of rights

    • Access to patients (all, his/her center, restricted to his/her own patients)
    • Data access (none, read only, read/write)
    • Centers management (create / edit)
    • User management (create, invitations to the study)
    • Queries management
    • Download Data
    • Access to shared documents
  • Randomization

    Randomization

    Randomization by block is configurable:

    • block size
    • unequal randomization
    • stratified sampling up to 3 levels
  • text data

    Monitoring

    Monitoring can:

    • be carried out on site or remotely
    • concern only certain fields of your study
    • concern only certain patients in your study (for example one in 5 patients)
  • Queries

    Queries

    If a numerical value is entered beyond the defined limits, a query is automatically sent by the software. Some profiles can issue queries, especially during the monitoring phase. When issuing a query, a dialog box is created under the field concerned. This communication space is used by investigators and users in charge of monitoring.

  • donnees texte

    Patient self questionnaire

    Part of your eCRF can be directly filled by patients. As part of a consultation or hospitalization to put patient's disposition a tablet connected to the internet to enable him/her to fulfill his/her questionnaire. Patients may also receive by mail a link allowing them to complete the questionnaire on their desktop but also on mobile and tablet. This email is sent automatically by following a predetermined schedule

  • alert email

    Alert emails

    Alert emails can be sent automatically

    • if doctor visits are not carried out
    • if patient questionnaires remain incomplete
    The list of recipients of these emails can be configured by type of alert: doctor who included the patient, ARC of the center, patient, ....
  • donnees texte

    Share your documents

    A space dedicated to sharing documents is present in Easy CRF. You can define for each document user profiles allowed to download.

    • investigator brochure
    • protocol
    • authorization from the authorities
    • information sheet and consent

In what format will I get my data?

Your data is available 24h / 24h in the download area of the Easy CRF platform. Depending on the architecture of the study, data are available in one or more data files. A statistical analysis report is also available.

An annotated CRF is available for download (.pdf). It includes all the questions eCRF annotated with information: name and variable type, boundaries.

  • donnees texte

    Données brutes

    Vos données seront disponibles dans un ou plusieurs fichiers de type texte (.csv). Ce format est utile pour importer les données dans des logiciels d'analyse statistique. De multiples formats de données sont disponibles (multiples formats de date, choix du séparateur de colonne, choix de la marque de décimal).

  • Import dans R Import dans SAS

    Script R - Script SAS

    An R script and a SAS script will carry out the declaration of the variables of your study in your statistical analysis software. The modalities of the categorical variables will be automatically integrated into it.

And data quality?

The quality of data is based on different elements:

  • eCRF filling
    The eCRF consists of mandatory and optional questions. The filling level of each page corresponds to the proportion of full mandatory question. Each patient's eCRF filling level is also calculated and displayed in the patient list.
    Page completeness may be blocking to access to pages for future visits.
  • Control of numerical data
    Boundary markers are définisables for each numeric field. The user is immediately notified if an input value is not a numerical value or if it falls outside the boundaries.
  • Audit trail
    The historical value of each field is available directly in the eCRF (who, what, when).
  • Queries
    Queries can be created for each field by the people in charge of monitoring. An email is automatically sent by the investigator concerned with the new query.
  • Missing data
    Missing data are highlited in the eCRF.

And what about security?

  • donnees texte

    Certified hosting of personal health data

    In accordance with established regulations regarding the collection of health data of a personal nature, Easy CRF hosts all its data to a host approved by the Ministry of Health : AZ Network

  • donnees texte

    Data security

    • access password. The password is renewed every 3 months
    • possibility of a double authentication (code received by SMS code and code received by email to create passwords)
    • TLS encryption of the connection by the use of a certificate issued by an official authority
    • Server with network intrusion detection & prevention system
    • twice daily data backup.
<

How much does an eCRF cost?

Turnkey formula
  • text data

    Annual cost

    From €1,900 excl. VAT/year and per study.
DIY Formula
  • donnees texte

    First year of operation

    The initial cost of a study includes
    • the creation of the eCRF
    • user teletraining
    • access to the hotline 24 hours a day, 7 days a week
    • the hosting and operation of the eCRF for one year of the eCRF from the first inclusion
    This cost does not depend on the number of patients included.
  • text data

    Next years

    The cost per additional year is 15% of the initial cost. It includes:

    • hosting and operating the eCRF
    • access to the hotline 24 hours a day, 7 days a week
    • updates of the security environment

Why choose Easy CRF?

  • donnees texte

    Easy CRF is listening to your needs

    Each study is different and needs change. Easy CRF develops new features, new modules of questions to create the most suitable environment for your study. Listening to you, Easy CRF evolves!

  • donnees texte

    You are never alone with Easy CRF

    Throughout the course of your study, Easy CRF is available 24/24 7/7. To you and all users of your study.

  • donnees texte

    We are proud of our references

    Since 2010, our eCRFs have been created for many users.

Contact us