Remote SDV by copies of source documents

The site uploads copies of the source documents without personal data, the monitor verifies the visit from the office, the copies are deleted after SDV.

Remote SDV is for when the monitor cannot travel to the site: the site uploads to a patient's visit copies of the source documents (a page of the outpatient record, a lab report) with the personal data blacked out, and the monitor compares the visit's forms with them from the office. Once the visit is verified, the copies are deleted and only the record of what was shown stays.

How the site uploads a copy

In the patient card, under each visit with saved forms, there is a link “Copies for remote SDV”. On the visit page, the “Upload a copy” form on the right asks for the name of the document, a JPEG, PNG or PDF file up to 30 MB and the box “I checked: no personal data shows on the copy”. Without the box or the name, the copy is not taken.

Before uploading, black out the full name, the address, phones, the policy, passport and medical record numbers and the photo of the face. Leave the patient code, the dates and the values: the monitor compares the data by them. The portal removes the metadata of pictures itself (the place, the phone model, the time).

The site takes back a wrong copy with the “Withdraw” button: its contents are deleted at once.

How the monitor verifies the visit

The copies of a visit as the monitor sees them: the copies and their buttons on the left, the forms of the visit and their SDV on the right.

The study menu item “Remote SDV” lists the visits with copies, the oldest first; the number on the menu item is how many copies wait for review. The monitor opens a copy with “Open”, compares the forms of the visit with it (the links on the right) and marks the forms verified as usual. The copy itself is marked “Reviewed”, with a note if needed.

If personal data shows on a copy, the monitor presses “Personal data shows” and writes what shows without repeating the data itself (for example “the full name on top of the page”). The copy is deleted at once, and the site sees why on the “Remote SDV” page and uploads a better one.

When the copies are deleted

• When the last form of the visit that the SDV plan asks for is verified: right after the mark, or within the hour if a mark was taken off and set again.
• With the monitor's button “Delete every copy of the visit” after the review.
• By the study's limit: at the latest 30 days after upload. The project manager changes the limit, from 1 to 365 days, on the “Remote SDV” page.

After deletion the list “Deleted copies” keeps the record: the name, the SHA-256 of the contents, who uploaded and reviewed it and when, when and why it was deleted.

Who sees the copies

Only the site of the patient and the monitors open a copy, and every opening goes to the audit trail. The data manager, the sponsor, observers, the export, the casebook and the API never see the copies. Uploading, reviewing, marking personal data and deleting are in the audit trail too.