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View additional form setting list

Source Data Verification (SDV) relates to the process of ensuring data accuracy and integrity within a clinical trial by reviewing and comparing the data recorded in the source documents, such as laboratory results, medical history, adverse event records, and so on against the data captured in the case report forms (CRFs). Once the SDV process is completed, the responsible personnel can review the findings and approve SDV.

Before the SDV process is initiated based on the sponsors requirements, a percentage plan is created that specifies what CRFs must undergo SDV. One such simple percentage plan is the global SDV, which is developed to outline how much of the CRF data must undergo verification.

At times, you might want to configure additional percentage settings for certain CRF data to undergo verification. This might be needed as the requirements of the sponsors are different due to the specifics of certain sites, prioritization of sensitive data fields, regulatory standards, and so on. If specific SDV configurations are set for any CRFs, they can be reviewed and managed from the Additional form setting block. Once additional percentage settings are configured for a specific CRF, the SDV process for such form follows its settings, while all the remaining CRFs of the study follow the global SDV percentage setting.

For instance, the global SDV setting is 70%, and a form "Chemistry" with variable(s) "LBPERF" and "LBDAT" is added to the Additional form setting with a percentage of 80%. In this scenario, 70% of data collected on all the study forms undergo SDV, and 80% of data collected on the variable(s) "LBPERF" and "LBDAT" from "Chemistry" undergo SDV.

In this section, you can learn how to analyze the details of the form specified in the Additional Form setting list.

To view the additional form settings list

  1. In the EDC application header, select the STUDY INFO tab.

  2. In the left pane of the page that opens, expand SDV and select the SDV Setting tab.

  3. On the SDV Setting - Global SDV page that opens, under the Additional form setting table, view the details of the forms with additional settings as explained in the following table.

    Viewing additional form settings
    Figure 1. Viewing additional form settings

    Element

    Details

    Form Name

    Represents the name of the form whose percentage differs from the global SDV.

    Variable(s)

    Represents the name of the variable(s) of the form whose setting has been changed.

    Percent(%)

    Represents the percentage of the variable(s) included in the SDV, that differs from the global SDV.

You have viewed the Additional Form Setting list which contains a form percentage plan that differs from the global SDV.

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

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.