An eCRF is an electronic form designed to collect information useful for clinical research in order to achieve the objective targeted by this research. Its content is based on the clinical research protocol. Access to the eCRF is nominative and protected by a password.

• 

  User Profiles and Rights

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

  Profile Examples

  • Sponsor
  • Principal Investigator
  • Co-investigator
  • Clinical Research Coordinator

  Rights Examples

  • Patient access (all/those from certain centers/restricted to own patients)
  • Data modification in the eCRF or read-only access
  • Center management (creation/modification)
  • User management (creation, study invitations)
  • Query management (clarification requests)
  • Data download
  • Access to shared documents
• 

  Randomization

  Block randomization is configurable:

  • block size
  • distribution of numbers between different arms
  • stratification up to 3 levels
• 

  Monitoring

  Monitoring can:

  • be performed on-site or remotely
  • concern only certain fields of your study
  • concern only certain patients in your study (for example, one patient out of 5)
• 

  Queries

  In case of numerical value entry beyond defined limits, a query is automatically issued by the software. Certain profiles can issue queries, particularly during the monitoring phase. When issuing a query, a dialog box is created under the relevant field. This communication space is used by investigators and users in charge of monitoring.

• 

  Patient Self-Questionnaires

  Part of your eCRF can be directly filled out by patients. During a consultation or hospitalization, provide your patients with a tablet connected to the internet allowing them to fill out the questionnaire. Patients can also receive an email link allowing them to fill out the questionnaire on their desktop computer as well as on tablet and mobile phone. This email is sent automatically following a calendar automatically established for each patient.

• 

  Alert Emails

  Alert emails can be sent automatically:

  • if medical visits are not performed
  • if patient questionnaires remain incomplete

  The list of recipients for these emails is configurable by alert type: doctor who included the patient, center CRA, patient, etc.
• 

  Document Sharing

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

  • investigator brochure
  • protocol
  • ethics committee opinion and authorization from competent authorities (AFSSAPS)
  • information notice and consent
  • copy of letter sent to hospital director
  • ...

Your data is available 24/7 in the Easy-CRF platform download space. Depending on the study architecture, data is available in one or more data files.

An annotated CRF is downloadable (.pdf). It includes all eCRF questions with annotated information: variable names and types, ranges. A variable dictionary (.xlsx) presents all variables, their type, their modalities, their display conditions, the mandatory or optional nature of their completion.

• 

  Raw Data

  Your data will be available in one or more text files (.csv). This format is useful for importing data into statistical analysis software. Multiple data formats are available (multiple date formats, column separator choice, decimal mark choice).

• 

  R Script - SAS Script

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

Data quality is based on different elements:

• eCRF Completion

  The eCRF is composed of mandatory completion questions and optional completion questions. The completion level of each page corresponds to the proportion of mandatory questions completed. The completion level of each patient's eCRF is also calculated and visible in the patient list.
  Mandatory completion can be blocking or not for access to future visit pages.

• Numerical Data Control

  Ranges can be defined for each numerical field. The user is immediately notified if an entered value is not a numerical value or if it is outside the authorized interval.

• Audit Trail

  The history of each field's value is available directly in the eCRF (who, what, when).

• Queries

  Queries (clarification requests) can be created for each field by people in charge of monitoring. An email is automatically sent to the investigator concerned by the new query.

• Missing Data

  Missing data and incomplete pages are distinguished by a dedicated color in the eCRF.

• 

  Approved Hosting for Personal Health Data

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

• 

  Data Security

  • access to studies by password renewed every 3 months
  • possibility of two-factor authentication (code received by SMS and code received by email to create passwords)
  • TLS encryption of connection using a certificate issued by an official authority
  • server equipped with anti-intrusion systems
  • daily backup of data.

• 

  First Year of Operation

  The initial cost of a study includes

  • eCRF creation
  • remote training of users
  • access to 24/7 helpline
  • hosting and operation of the eCRF for one year from the first inclusion

  This cost does not depend on the number of patients included.
• 

  Following Years

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

  • hosting and operation of the eCRF
  • access to 24/7 helpline
  • security environment updates
• 

• 

  Easy-CRF Listens to Your Needs

  Each study is different and needs evolve. Easy-CRF develops new features, new question modules to create the environment most adapted to your study. Listening to you, Easy-CRF evolves!

• 

  You're Never Alone with Easy-CRF

  Throughout your study, Easy-CRF is by your side 24/7. For you and all users of your study.

• 

  We're Proud of Our References

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