Review and Source Data Verification are two separate stamps that answer two different questions. Review says a form has been looked at. SDV says a specific value matches the paper it came from. Most studies use both, and they are configured together.
🔑 Prerequisite: eCRF Records (Review) to stamp a form, eCRF Records (Verify Source Data) to mark SDV, and Monitoring (Access) for the dashboards. The study must also have eCRF Review switched on, which is covered at the end of this article.
Which one am I doing?
Data review | SDV | |
Applies to | A form, which is a sub-section | One question |
Means | This form has been checked | This value matches the source document |
Usually done by | A data manager or reviewer | A CRA, on site or remotely |
Bulk option | One form at a time | Yes, all visible questions on a form at once |
Stamp a form as reviewed
🛠️ Step by step guide
Open the subject's eCRF and go to the form.
Read the data.
Select the review control on the form.
The form is then marked as reviewed, with the date and your name.
⚠️ Warning: any change to the data on that form removes the reviewed stamp. This is deliberate, since a review of data that has since changed is not a review, but it means reviewing a form that is still being completed is work you will do twice. Review forms that are finished.
What the review stamp does and does not mean
The stamp records that a named person looked at a form on a date. It has no other effect anywhere in the platform: it does not gate locking, signing or export, and it does not change the eCRF status.
That makes it deliberately flexible. Your study decides what "reviewed" means in your monitoring plan, and the stamp records that it happened. It also means the stamp is only as meaningful as the plan behind it, so write the plan down.
Mark data as verified against the source
🛠️ Step by step guide
One value
Open the eCRF and go to the form.
Compare the value on screen against your source document.
If it matches, select the ··· menu on the question.
Select Add SDV.
Move to the next value.
Every visible value on a form
Check the values against your source documents.
Select the SDV control at the top of the form.
Each mark records who verified the value and when.
💡 Tip: SDV is one of the few actions that still works on locked data. On a question inside a locked form, the ··· menu keeps Add SDV and Audit trails and loses everything else, so a CRA can finish verifying a form that a data manager has already frozen.
Track both from the dashboards
Both stamps have their own tab under eCRF > Monitoring, and they are built differently because they work at different levels.
Data Review tab | Source Data Verification tab | |
One row is | One subject's eCRF | One question |
Progress means | The percentage of that subject's forms reviewed | The percentage of values verified |
The cards count | Reviewed and unreviewed forms | SDV required, and SDV performed |
Filter by | Center, status | Center, subject, question, status |
🛠️ Step by step guide
Open the study and go to eCRF > Monitoring.
Open the Data Review or Source Data Verification tab.
Use Add filter for a center, and Save it for next time.
Use Filters to narrow by status, and on the SDV tab also by subject or question.
Select the eye icon to jump to the form or the value.
Do the work, then use the back control to return to the list.
💡 Tip: the SDV tab shows each question by its variable name as well as its label, which is how a data manager working from an export finds the value behind a column.
Switch eCRF Review on for a study
Neither stamp exists until this is done, and it is done once per study.
🛠️ Step by step guide
Open the study and go to Settings > Options.
Select Edit.
Switch on eCRF Review.
Save.
A new dashboard appears under eCRF > Monitoring, and the review and SDV controls appear in the subject forms.
⚠️ Warning: this is why the same screen looks different to two colleagues. On a study without eCRF Review, the Data Review and SDV tabs are absent, the review controls do not appear in the forms, and the Visit (Event) view shows one badge fewer per visit. Before treating a missing control as a bug, check the study's Options.
Give the right roles the two permissions
Switching the study option on makes the feature exist. It does not give anybody the right to use it. Review and Verify Source Data are separate toggles, so a study can grant one without the other, which is how a CRA ends up able to verify values but not stamp forms.
🛠️ Step by step guide
Go to Settings > Roles.
Open the role you want to configure and select Edit.
Open the eCRF Records block and switch on Review, Verify Source Data, or both.
Open the Monitoring block and switch on Access, so the role can see the dashboards.
Save, and repeat for each role that needs them.
For the full picture of what every eCRF permission controls, see Roles and Permissions Management.