Managing Site Visits for Blinded and Unblinded Users

You manage site visits by navigating to the Site Management screen, Protocol Site list view, drilling down on a Site, and then navigating to the Site Visits view.

From the Site Visits view, you can create new site visits. Note the following about managing site visits for blinded and unblinded users:

• Site Visits created by unblinded users are unblinded. In this case, the Unblinded field for each unblinded site visit is selected (Unblinded=Y) and the site visit is highlighted in the color red.

• Site Visits created by blinded users are blinded. In this case, the Unblinded field for each blinded site visit is deselected (Unblinded=N or Null).

• Unblinded users can either view blinded site visits in read-only mode (depending on the protocol level setting Hide blinded content for unblinded users) or cannot view blinded site visits at all.

• Blinded users cannot view unblinded Site visits and they:

  • Cannot be assigned to an unblinded Site Visit.

  • Cannot be assigned to Checklist Activities, Follow-up items or All follow-up activities of an unblinded trip report.

• When the protocol level setting Hide blinded content for unblinded users is not selected and an unblinded user has read-only access to blinded site visits, then the following conditions are true:

  • Trip report Checklist Activities are read-only.

  • Trip report Follow Up Activities are read-only.

  • Unblinded trip reports will show only unblinded records in the All follow Up Activities view.

  • Trip report Case Report Form Tracking is read-only.

  • The New File and New URL options in Site Visit Attachment is disabled.

• If the protocol level setting Hide blinded content for unblinded users is selected, then for unblinded users, unblinded trip reports will show only unblinded records in the All Follow Up Activities view.

• All versions of a blinded site visit will remain blinded, and all versions of an unblinded site visit will remain unblinded.