Definition:

Source Data Verification (SDV) is the process of reviewing and verifying data against source records to ensure accuracy.

The Source Data Verification screen is the Monitor’s Home screen where they perform Source Data Verification (SDV).

To Access the Source Data Verification screen:

Click Tasks in the header bar of Study Runner, and select Source Data Verification.

The SDV Table

The Source Data Verification table displays the SDV Status, Open Queries, SDV Requirements, CRF Status, etc.

SDV Requirements

SDV requirements are defined by your study protocol. Data Managers and Administrators can specify the level of SDV requirement for each item on a form in Study Designer. Below is a table that displays basic definitions of each SDV Requirement.

IconSDV RequirementDescription
(No Icon)Not Applicable (Default)SDV is not applicable for this form.
Not RequiredSDV is not required for the form, but you can still perform SDV if you want. This is often used when 10% of Forms need to be SDVed. Each form record is verified or unverified all together, rather than item-by-item
Partial RequiredSome fields on the form must be verified. Each form record is verified or unverified all together, rather than item-by-item
100% RequiredEvery field in the form must be verified. Each form record is verified or unverified all together, rather than item-by-item
Item-LevelItem-Level SDV allows you to choose which items will be part of SDV by selecting Required, Optional, or Not Applicable for each individual item on a form. Item records will then be marked as Verified or Not Verified independently and will become unverified independently if their data changes on the form.
Item-Level (To be configured)This indicates Item-Level SDV was selected, but is not configured validly since all items are set to Not Applicable. Use the Configure SDV link on the Form card in Study Designer to set each item to Required, Optional, or Not Applicable. At least one item needs to be Required or Optional, otherwise change the form’s SDV Requirement to Not Applicable.

Not all forms will have all SDV Requirement options available. The SDV options are related to when the form was created and when it was published to Production in relation to the Stack 15 release (December 20th, 2021). The SDV options on forms are as follows:

  • Form first published to Production prior to Stack 15 release: Not Applicable, Not Required, Partial Required, 100% Required
  • Form created prior to Stack 15 release, but not yet published to Production: Not Applicable, Not Required, Partial Required, 100% Required, Item-Level
  • Form first published to Production after Stack 15 release with one of the following statuses – Not Required, Partial Required, 100% Required: Not Applicable, Not Required, Partial Required, 100% Required 
  • Form first published to Production after Stack 15 release with one of the following statuses – Not Applicable, Item-Level: Not Applicable, Item-Level 
  • Form created after Stack 15 release: Not Applicable, Item-Level
    • Individual items have the following SDV Requirement options: Required, Optional, or Not Applicable 
      • When first selecting Item-Level on a form, the item is set to Optional by default. Additional items that are added will default to Not Applicable.

Item-Level SDV Requirements:

  • Not Applicable: items cannot be verified
  • Optional: items can be verified
  • Required: items must be verified for the form to be fully verified and get Verified status

The Source Data Verification table only displays completed forms with an SDV requirement other than Not Applicable.

You can click Show More to show more rows or filter a column by clicking the gray box below the column header.

Forms can have a status of Ready to verify, Changed since verified, or Verified.

Items can have a status of Not Verified, and Verified.

Form-Level:

If a value on a verified form was changed, the status of the form will become Changed since verified, and the form must be verified again.

Item-Level:

If the value of a verified item (Required or Optional) was changed:

  • If the form was verified, the form becomes Changed since verified and the item becomes Not Verified
  • If the form was not verified, the status of the form does not change, and the item becomes Not Verified

If an additional repeating group occurrence containing a Required item was added to the form:

  • If the form was verified, the form becomes Changed since verified and the Required item remains Not Verified.
  • If the form was not verified, the status of the form does not change and the Required item remains Not Verified.

SDV Form Statuses are as follows: 

IconStatus
Ready to verify
Changed since verified
Verified

You can sort the columns, such as Event Date by clicking the column header.

The Open Queries column displays the number of queries that are open (New or Updated) for a specific CRF. This is a good way to keep track of which CRFs are likely to change due to outstanding queries.

If the number of queries is 0, the number appears as plain text. If the number of queries is greater than 0, it appears as a link. If you click the link, it takes you to the Queries screen, which is filtered to the Participant, Form, and Event that the row in the SDV table corresponds to.

The CRF Status column displays the status of the form as well as whether it is Locked, Signed, etc.

Click the View CRF (magnifying glass) button in the Actions column to open the form in Review-Only mode (unless the form is in a status of Locked, in which case, the form opens in Read-Only mode).

Click Data to view form information and review the items individually. Use the radio buttons in the upper-right corner to view only the specific data you want to review on the form:

Form Level:

  • Show all items: displays all items on the form
  • Show only changed since last Verified: displays items that have had a value changed since the form was verified

Item-Level:

  • Show all items: Shows all items on the form regardless of SDV requirement or status
  • Show all SDV items: Shows all SDV Required or SDV Optional items regardless of status
  • Show items needing verification: Shows all SDV Required items with unverified status

Verifying Data

Use Case(s):

  • The information on the form has been changed to address a query.
  • A response clarifies why the existing information is accurate.
  • The SDV Plan requires Source Data Verification regardless of whether or not there is a query.

To Perform Source Data Verification:

  1. Click the View icon in the Actions column to view the completed form.
  2. Compare the data entered in the form against the source record. If there are any discrepancies between the source record and the data on the form, click the Query Bubble for the item in question and create a query for the site to address.
  3. Complete the review of the data and close the form.
    1. Click Verify to verify all items on that form, or
    2. Check off each form on the SDV Forms Table and then click Verify All Checked to verify multiple forms at once.

Alternatively, you can click the Data button and review the data. Then select items to verify and click Verify All Checked.

When the final SDV Required item on a form becomes Verified, the form will become Verified. If there are no SDV Required items configured on a form, verifying the final SDV Optional item on a form will verify the form.

Clicking Verify for a form will mark all SDV Required items on that form as verified.

Note: If you inadvertently marked a record as Verified, you can reset its status by clicking the double-check icon in the SDV Status column. You are prompted to confirm resetting the status. If a form is marked as not verified after it was verified, this does not reset the status for all items on the form. Use the Data button to update the SDV status for individual forms as needed.