A eCRF: how it works?

Operation

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.

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    Profiles and user rights

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

    Example 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
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    Inclusion centers

    Using inclusion centers are not required to run a study, but it helps

    • to plan to send invitation mails when the center opened
    • to share the same patients in centers

    In the absence of center, users can register spontaneously to a study by visiting the home page of your study. Thus, the recruitment of investigators in a study can be done as part of an oral scientific communication or by emailing.
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    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. L'accès de ces autoquestionnaire ne permet pass au patient d'accèder a d'autres parties du ecRF

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    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.

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    Raw data

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

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    Fichier Excel

    Your data is available in Excel 2007 format (file extension: .xlsx). The version of Excel 2003 (.xls) is not offered by Easy CRF because it cannot support more than 256 columns.

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    Statistical Analysis Report

    A statistical analysis report can finally be generated at any time in pdf format (.pdf) and Word 2007 (.docx). Each categorical and continuous variable will have a descriptive statistical analysis. Sub groups analyzes are possible as well as survival curves.

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.
  • Dates
    Rules can be defined to structure the scheduling of dates. Queries are issued automatically as soon as a discrepancy between two or more dates appear.
    Dynamic display: questions can appear depending on answers already provided.
    users see the filling level of each page of his/her patients.
  • 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. The list of missing data is available for each user (for his/her patients). The complete list of missing data is available to the team managing the study. This information is downloadable.

Monitoring

Different information can track a study

  • global inclusion curves, by center, per user
  • filling level of each page of patients
  • list of current queries (click provides access to affected field)
  • list of missing data (click provides access to affected field)
  • display the next scheduled visits

What your investigators will see

Investigations have limited rights to the following features:

  • Access to the list of their patients (with queries indicator, level of completeness by page and global)
  • Include patients
  • Access to the list of their missing data
  • Access to the list of their queries
  • Edit the information on their identity
  • Display the next scheduled visits
A number of emails are sent to investigators:
  • if a new document is shared
  • a few days before a visit scheduled date
  • if a query is issued about one of their patient

And what about security?

  • 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

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    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.

Why choose Easy CRF?

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    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!

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    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.

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    Your money is used for your eCRF

    Your money will not be for a team dedicated to marketing or advertising: Easy CRF do not have any.
    Easy CRF has chosen to rely on the trust of its customers to grow.

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