Skip to main content

Configuring general SDV setting

Source Data Verification (SDV) involves the review and comparison of data recorded in the source documents such as laboratory results, medical history, adverse event records, and so on against the data captured on the case report forms (CRFs). During SDV, a trained monitor or clinical research associate (CRA) compares the source data to the CRFs to identify any discrepancies or errors.

Important

Configuration of the SDV procedure depends on the SDV setting type selected for your study—global, general, or target SDV. This section explains the configurations required if the General SDV type is established for the study.

For the general SDV setting type, before the SDV process is started, a plan is developed to outline how much of the CRF data must undergo verification. According to the developed plan and based on the study specifics, the sponsor decides what amount of such data needs to be verified. In the EDC application, you can specify what forms and what percentage of data fields need to undergo SDV by adding the SDV setting record.

For example, you want all of the adverse event (AE) data to be checked against the source documents. To accomplish this, you can add the SDV setting record which needs to specify that 100% of Adverse Events forms in all visits must undergo SDV. In this case, SDV approval is required for all AE forms.

When defining the procedure for the general SDV type, you can add SDV setting records by form, by visit, or by subject as explained in the following sections.

Add SDV setting record by form

When defining the procedure for the general SDV type, you can add SDV setting records by form. This means that you define if all data fields in a specific CRF or CRFs must undergo SDV or only some random part of it.

To add the SDV setting record by a form

  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 - General SDV page that opens, select the By Form tab.

  4. From the workspace toolbar, select New Item add_new_icon.png.

    Adding new SDV setting record by form
    Figure 1. Adding new SDV setting record by form

  5. In the Add dialog that appears, fill in the details as explained in the following table.

    Configuring new SDV setting record by form
    Figure 2. Configuring new SDV setting record by form

    Tip

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

    Element

    Details

    Form Name*

    Select the form that must be verified against the source document after completion.

    Percent(%)*

    Enter the number representing the percentage of form fields out of the general amount of fields that have to be verified against the source document.

    For instance, enter 100 if you want all form fields to be verified, or enter 50 to only make the verification of half of the form fields required.

    Applied Visit(s)*

    Select visits where the configured SDV setting must be applied for the selected form.

    Variable(s)*

    Select variables to which the configured SDV must be applied on the selected form.

    Applied Phase(s)*

    Select subject phases to which the configured SDV must be applied on the selected form.

    SAVE

    Select save_button_red.png to add the selected form to the list of those to be verified.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes and close the dialog.

Once saved, the SDV setting record is added. You can now execute the SDV setting to apply the configuration.

Add SDV setting record by visit

When defining the procedure for the general SDV type, you can add SDV setting records by visit. This means that you define if all the data collected in CRFs of some visits must undergo SDV or only some random part of it.

To add the SDV setting record by a visit

  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 - General SDV page that opens, select the By Visit tab.

  4. From the workspace toolbar, select New Item add_new_icon.png.

    Adding new SDV setting record by visit
    Figure 1. Adding new SDV setting record by visit

  5. In the Add dialog that appears, fill in the form as explained in the following table.

    Configuring SDV setting record by visit
    Figure 2. Configuring SDV setting record by visit

    Tip

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

    Element

    Details

    Visit Name*

    Select the visit whose forms must be verified against the source document.

    Percent(%)*

    Enter the number representing the percentage of forms completed at the selected visit that must be verified against the source documents.

    For instance, enter 100 if you want all the forms from the visit to be verified, or enter 50 to only make the verification of half of the forms required.

    SAVE

    Select save_button_red.png to add the selected visit to the list of those to be verified.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes and close the dialog.

Once saved, the SDV setting record is added. You can now execute the SDV setting to apply the configuration.

Add SDV setting record by subject

When defining the procedure for the general SDV type, you can add SDV setting records by visit. This means that you define if all the data collected in CRFs of all visits for the specific subject must undergo SDV or only some random part of it.

To add the SDV setting record by a subject

  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 - General SDV page that opens, select the By Subject tab.

  4. From the workspace toolbar, select New Item add_new_icon.png.

    Adding SDV setting record by subject
    Figure 1. Adding SDV setting record by subject

  5. In the Add dialog that appears, fill in the form as explained in the following table.

    Configuring SDV setting record by subject
    Figure 2. Configuring SDV setting record by subject

    Tip

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

    Element

    Details

    Subject ID*

    Select the subject whose CRF data must be verified against the source document.

    Percent(%)*

    Enter the number representing the percentage of completed forms for the selected subject that must be verified against the source documents.

    For instance, enter 100 if you want all the forms for this subject to be verified, or enter 50 to only make the verification of half of the forms required.

    SAVE

    Select save_button_red.png to add the selected subject to the list of those to be verified.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes and close the dialog.

Once saved, the SDV setting record is added. You can now execute the SDV setting to apply the configuration.

In this section:

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

See also eCRF.

A person who is the main line of communication between the sponsor and the investigator. The monitor provides assistance to investigators, ensuring that the trial is conducted and documented properly. In the clinical trial industry, often referred to as a clinical research monitor or clinical research associate (CRA).

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.

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.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.