Trial sites · Sponsor monitors · CRAs
Let sponsor monitors check source documents remotely, with patient identifiers redacted.
Trial sites redact patient identifiers from source documents, share them with the sponsor's monitor at View only for each visit, and keep a view log for GCP inspections.
- Identifiers redacted
- Burned into a new copy.
- Per visit
- View only for the monitoring visit.
- Monitor access
- Ends when the visit does.
- View log
- Who viewed each document, for inspections.
Why remote monitoring is hard
Monitors need to verify source data against the trial record, but source documents carry patient names, record numbers and dates of birth.
Today
- Monitors travel to the site
- Source documents scanned and emailed
- Identifiers blacked out by hand
- No record of what the monitor saw
With DekkoCORE
- Monitors review from anywhere
- Source documents shared View only
- Identifiers redacted in the PDF
- A view log for each visit
How it works in DekkoCORE
One monitoring visit, from preparing the documents to the view log.
Step 1
Prepare the visit's folder
Put the source documents for the visit in their own folder.
- Hub folders
Step 2
Redact identifiers
Search for names, record numbers and dates of birth, and redact every match at once.
- Redaction
- Redact all
Step 3
Check the redacted copy
Check every page before sharing: a search finds text, not pictures of text.
- Redacted copy, original kept
Step 4
Share it for the visit
Share the folder with the monitor at View only, ending when the visit ends.
- View only
- Access expiry
Step 5
Keep the view log
Each file lists who viewed it and when, ready for a GCP inspection.
- File history
- Audit log
Who gets what access
A typical visit. You can change or remove anyone's access at any time.
Site study team
Full permissions
Prepares and redacts the source documents.
Principal investigator
Manager
Oversees what's shared.
Sponsor monitor
View only, for the visit
Verifies source data.
Auditors and inspectors
View only
Review the record.
The bars show a permission level, from Listing only (one bar) to Full permissions (seven).
Questions
Can monitors download source documents?
Not with View only. They read the documents in the browser, and their access ends when the visit does.
Does redaction work on scanned source documents?
Redaction works on PDFs. A search finds words in a PDF's text, so scanned pages without a text layer need to be redacted by hand.
What does the view log show?
Each file lists who viewed it and when, and the audit log exports as CSV for inspections.
Is this for the site or the sponsor?
This page covers the site's side. For sponsors sharing data with CROs and partners, see Drug development.
Where are the documents stored?
DekkoCORE is hosted in-country, in Australia, the United States or Canada.
Hosting remote monitoring visits?
Tell us how monitors review source documents today. We'll show you the same visit in DekkoCORE.