Verify a completed form (Source Data Verification) in EDC/CDMS
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If you are a monitor performing source data verification (SDV) you can mark forms and visits as source-data verified. The verification type first needs to be set up by the study admin, find out how here.
To be able to verify a form, you need 'Verify' rights.
Mark a form/visit as verified
To mark a form or visit as verified, follow these steps:
- Open the participant where you want to perform SDV or any other data verification that is relevant for your study
- Go to the visit or form that you want to verify. Select the three dots next to a visit or form and click on 'SDV this form':
If you select the ‘Custom verification’ option and there is only one verification type defined in the study, this will be automatically selected.
If there are two or more, then you will need to choose which type of verification you want to use. You can also select whether the verification will need to be dropped when data is being modified:
If you select 'Yes' for the above option, the verification will be removed when another user modifies data in that form or visit. Click 'OK' to save the verification or 'Cancel' to discard the change and return to the data entry view.
- The form or visit will be marked as verified with a blue banner indicating the date and time of verifying as well as the user name. A checkmark appears above the bullet next to each verified visit/form in the form navigator to the left. If two users need to verify the same data, the banner will appear two times.
In the banner, you will see the option to 'remove' the verification, but only if you are the one who has done the verification. You can use that if you want to remove the verification for whatever reason:
You can see that forms are verified when the checkmark next to its status is shown.
In the participants tab, when using the 'Progress by visits/forms' view, you will also see a checkmark in the bottom left corner of each form/visit that has been verified.
If a form/visit was also signed (in addition to verified), two checkmarks will be shown and hovering over the checkmark will show what it indicates.
Mark a field as verified
To mark a field as verified, follow these steps:
- Open the participant where you want to perform SDV or any other data verification that is relevant for your study.
- Go to the field that you want to verify. Select the cogwheel next to field and click on 'SDV field':
Please note that in fields where there is an outstanding query or missing data, you will need to confirm that it is your wish to verify these fields.
If all fields within the form have not been verified, the SDV banner will not appear on top of the form.
Modifying data in a verified form
Once you have verified a form, a data entry user may need to modify the data. If this is done, the verification will be removed in that form or visit. If the study admin has set up a notification for dropping of form or field verifications, then the chosen user will be notified whenever this occurs.
Note: The SDV will not be dropped when a query is added or closed - only when the data is changed.