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Export CRF version

A CRF stands for case report form, a document used in clinical trials to collect and record study data. As the trial evolves, new insights or challenges may emerge, requiring changes to the CRF. These modifications, especially after data collection has commenced in the EDC system, lead to what is known as versioning. This process involves adapting the CRF to new protocol requirements or data collection processes during the clinical trial.

When maintaining CRF versions, you can export specification documents related to any of them. This functionality facilitates the download of files associated with a particular CRF version, including structure details and compliance-related documents. The export is pivotal in ensuring comprehensive access to all relevant resources required for review, adherence to regulatory standards, and management of the data collection process.

Important

You can only export specification documents for submitted CRF versions.

To export a CRF version

  1. In the Study Designer application header, select the VERSIONING tab.

    Accessing CRF versions
    Figure 1. Accessing CRF versions

  2. From the workspace toolbar of the Version Information table that appears, select the needed lifecycle and role.

    Selecting lifecycle and role
    Figure 2. Selecting lifecycle and role

  3. In the Version Information table, next to the needed CRF version, select Export icon_export.png.

    Selecting to export CRF version
    Figure 3. Selecting to export CRF version

  4. In the Archive List dialog that appears, select the documents you want to export. This list of available document types is explained in the following table.

    Exporting CRF version documents
    Figure 4. Exporting CRF version documents

    Document type

    Details

    Annotated CRF (Un-editable).pdf

    A file containing the CRF version with annotations indicating datasets and variables where the data is to be stored after being collected in EDC.

    Blank CRF (Un-editable).pdf

    A clean version of CRF without any guidance text or annotations that can be used for printing or electronic data entry.

    Annotated Unique CRF (Un-editable).pdf

    A file that contains the CRF version with unique form annotations only.

    Blank Unique CRF (Un-editable).pdf

    A file containing the CRF version with all unique forms used in the study.

    Annotated CRF (Editable).pdf

    An editable file containing the complete set of case report forms with technical annotations, including variable names, domain references.

    Blank CRF (Editable).pdf

    An editable file displaying the complete set of empty case report forms without any data entry or technical annotations, such as variable names and domain references.

    Annotated Unique CRF (Editable).pdf

    An editable file containing each unique case report form of current study with annotations, eliminating duplicate form types while retaining all variable names, database field references, and coding information.

    Blank Unique CRF (Editable).pdf

    An editable file containing one instance of each unique case report form with technical annotations, including variable names and domain references.

    Edit Check.xlsx

    A spreadsheet with edit checks that are to be applied during data entry in EDC.

    DB Spec.xlsx

    A specifications file outlining the structure of data that is to be stored in the database for this CRF version.

    ODM.xml

    An ODM file that defines the data structure in the XML format and can be used for data exchange with external systems.

    Schedule of Assessments.xlsx

    A spreadsheet outlining the established schedule of assessments for the study.

    ALS.xlsx

    The Architect Loader Spreadsheet document that is used for managing and loading the structure of a CRF version into the Medidata Rave EDC system.

    Designer Metadata.xml

    A file that contains XML metadata related to the CRF version, such as field definitions, form layouts, and other design elements.

    Help Text.csv

    A CSV file containing help text that is to be displayed within EDC for each field or section of the CRF version.

    Metadata.xlsx

    A spreadsheet that contains general information about the entire structure of the CRF version, including its design, codelists used, subject phase configurations, and more.

    Visit Form List.xlxs

    A spreadsheet showing one instance of each unique case report form without data entry or technical annotations (variable names, domain references, or database mappings).

    Translated CRF

    Select the respective translated CRF version to export a specific document related to any item. You can only export those documents whose CRF version is translated into a specific language. This makes it easy to send the translated CRFs directly to sponsors.

    The system supports languages such as Spanish, Japanese, Arabic, and more. The character placement and text alignment in the exported version correspond to the linguistic requirements of the selected language.

    Translated CRF
    Figure 5. Translated CRF

    Important

    Some document types may be unavailable if related specifications have not been configured for a particular CRF version.

  5. Select export_button_red_white.jpg to download the selected documents.

Once selected, the CRF version documents are exported to your computer.

Viewing CRF version document
Figure 6. Viewing CRF version document

In this section:

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

A standardized data model developed by CDISC to provide vendors with a structured way to represent, store, archive, and share the clinical trial data and metadata. The ODM file in the XML format allows for preparing and maintaining study design, forms, and items, keeping audit trails, and other aspects for efficient and consistent data exchange between systems (like SD and EDC), stakeholders, regulatory authorities, and more.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.