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Edit 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 the study is added to eClinical and basic information is entered in Study Designer (SD), the very first CRF version is automatically generated. To work with this version, you can simply start designing the CRF by creating visits, adding new forms, defining dependencies, and so on. However, if this version has already been published to EDC for data collection purposes but now requires updates, a new CRF version can be created.

If you only need to change a few details specific to the CRF version that has not been published to EDC yet, you can simply edit the CRF version through the VERSIONING tab. The updated information is populated to the CRF Setting subtab of the CONFIGURATION tab, where it is not editable but available for informative purposes to SD users. Any changes you make when you edit a CRF version appears in the CRF Setting subtab.

To edit 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 More more_actions_icon.png > Edit pencil_icon.png.

    Selecting to edit CRF version
    Figure 2. Selecting to edit CRF version

  3. In the Update CRF Version dialog that appears, provide CRF version details as explained in the following table.

    Updating CRF version
    Figure 3. Updating CRF version

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Base on*

    Select the previous CRF version based on which you want to create a new one.

    Version Name*

    Enter the updated version name of the CRF version and the date when the version is created.

    The CRF Creation Date field does not appear in the cover page of the CRF version reports, so you have to manually enter the CRF creation date after the version name.

    Master Version

    Represents the CRF version of the master study that is currently published to EDC in the same lifecycle—DEV, UAT, or PROD. This version is referenced by the substudy during CRF design and version submission.

    The value is autopopulated by the system and cannot be manually changed. This field is only available when creating a CRF version for a substudy.

    CRF Version*

    Enter a custom version of the CRF to comply with the protocol of your study.

    Comment*

    Enter a reason that explains the need for creating a new CRF version.

    You can edit the information in this field from when the CRF is in the draft stage until just before it's published to EDC.

    Protocol Full Name*

    Enter the full protocol name of the new CRF version.

    You can edit the information in this field from when the CRF is in the draft stage until just before it's published to EDC.

    Protocol Version*

    Enter the protocol versions of the CRF.

    A CRF can be linked to multiple protocol versions.

    You can edit the information in this field from when the CRF is in the draft stage until just before it's published to EDC.

    Significant Changes

    Enter the significant changes that were applied to the new CRF version.

    These changes help the users better understand what the changes are and why they were implemented.

    You can edit the information in this field from when the CRF is in the draft stage until just before it's published to EDC.

    Show CRF Setting

    Select this checkbox to show the CRF Setting information that you can configure.

    Date Item Format*

    Select the default date format to display on date fields when performing the CRF design.

    Time Item Format*

    Select the default hour format to display on time fields when performing the CRF design.

    Precision of float item*

    Select the default precision number for all float items when performing the CRF design.

    Required Field Tip*

    Enter the text to be displayed on the hover over the CRF fields that are required when entering data in the EDC application.

    Required Checkbox Tip*

    Enter the text to be displayed on the hover over the CRF fields with checkboxes when entering data in the EDC application.

    Data Required Edit Check

    Select this checkbox if you want all CRF date fields to undergo edit check validation.

    Missing data affects form status

    Select this checkbox if you want the missing date data to affect the status of CRFs when entering data in the EDC application.

    Check date item

    UNK check*

    Select one of the following options:

    • Unchecked: when entering data to CRFs in EDC, the system does not check if the date values are indicated as UNK (unknown).

    • Not allow: when entering data to CRFs in EDC, no option is available to select the UNK (unknown) value for date fields.

    • Generated EC: when entering data to CRFs in EDC, the system generates the edit check system query if there are UNK (unknown) values in date fields.

    Check time item

    UNK check*

    Select one of the following options:

    • Unchecked: when entering data to CRFs in EDC, the system does not check if the time values are indicated as UNK (unknown).

    • Not allow: when entering data to CRFs in EDC, no option is available to select the UNK (unknown) value for time fields.

    • Generated EC: when entering data to CRFs in EDC, the system generates the edit check system query if there are UNK (unknown) values in time fields.

    Default UNK Day

    Select the default day number to be considered during date calculation or comparison if the UNK (unknown) value is entered as a day on the CRF.

    Default UNK Month

    Select the default month to be considered during date calculation or comparison if the UNK (unknown) value is entered as a month on the CRF.

    Default UNK Year

    Select the default year to be considered during date calculation or comparison if the UNK (unknown) value is entered as a year on the CRF.

    Lab Range Extreme Limit Check

    Select this checkbox so the system uses the specified lower and upper extreme limit ratio set in the Lab Admin module when checking the laboratory test results.

    Lab Range check Tip

    Enter the text to be displayed on the hover over the CRF fields if the laboratory test results exceed the lower or upper extreme limit.

    Review Setting

    DM Review

    Select this checkbox to enable the data manager (DM) review of the study data.

    If the DM review is not required, clear the checkbox.

    CRA Review

    Select this checkbox to enable the clinical research associate (CRA) review of the study data.

    If the CRA review is not required, clear the checkbox.

    Safety Review

    Select this checkbox to enable the safety review of the study data.

    If the safety review is not required, clear the checkbox.

    SAVE

    Select save_button_red_white.png to update the CRF version settings.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes without saving.

Once saved, the settings for the CRF version are updated and populated to the CONFIGURATION > CRF Settings subtab.

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.

An overarching clinical trial protocol designed to achieve clinical trial objectives under a unified framework. This approach simplifies clinical development by introducing multiple substudies to operate under the same regulatory and operational entity.

An individual component of a master study protocol with its specific objectives, such as evaluating a product, dose, or subject category. Substudy inherits the core structure and governance from the master one but has its own endpoints.

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.

clinical research associate (CRA)