How do I set up Source Data Verification (SDV)?

Learn how to setup the Source Data Verification (SDV) feature in Climedo.  

With the Source Data Verification (SDV) feature, the verification process of input field data can be documented within the input form of a subject. During the study setup, the user can select which fields should be verified to enable a risk-based monitoring approach. SDV is available for (S)AE, scheduled and unscheduled events, and samples.

The SDV status percentage can be viewed in the subject or (S)AE overview and can be included in the "Subject status" and "(S)AE status" reports to export the respective data per subject.

Setup

SDV can be configured in the study setup in step 3.

Within the input form settings, SDV can be activated in two ways:

For individual input fields in the input field settings pop-up.
For all applicable input fields at once via the toggle in the input form settings.

All SDV configurations will be shown in the annotated PDF.

User Rights

The right to setup the SDV feature is covered within the management right to update input forms & fields. The right to verify input field data, however, needs to be configured separately in the site rights of the collaborator in the study settings step 2.

The SDV verification rights are further divided into “(S)AE” and “data verification”, which covers (un)scheduled events and sample forms. Each of these sections have a right called “verify”. When a user has this right, he/she can change the SDV status of input fields in (S)AE forms or (un)scheduled events and sample forms, respectively.

Read more about the usage of the SDV feature in the following article: How do I verify the entered data in Climedo?