In 2015, Protocol First (P1) developed a unique solution for uploading source data for industry-sponsored trials, specifically complex, interventional trials. This Source Upload solution is
The P1 solution was not specifically developed to support remote clinical monitoring during a pandemic. Yet, it is the right tool to cope with the current situation and the ensuing aftermath.
Protocol First’s Source Upload product, which runs (on a different screen) alongside any EDC system (e.g., Rave, InForm, Medrio, IBM, etc.) allows site coordinators to upload unredacted source data, at the click of a button. Remote monitoring made simple. Keep your trials running.
The CRA/monitor can remote monitor the data, mark it as reviewed, issue queries to the site, and download metrics reports for management, CTMS or eTMF.
Only Monitors/ CRAs have access to view the uploaded source. They can mark the data as reviewed or issue a query to the site for clarification. The system generates metrics reports, which can be downloaded or retrieved via our API. You can thus document your monitoring activities in your CTMS or eTMF.
We take your protocol and CRFs and configure a “Source Upload” view of the data, following the visit schedule. The system provides guidance to the site regarding what source data to upload for a given visit or down to a specific procedure. You can also offer source upload data for key logs (e.g., ConMeds, Medical History and AEs).
You can always complete monitoring when things return to normal. But when will that be? Partial and focused remote monitoring will allow you to keep your trial moving and return to normal faster.
Only Monitors/ CRAs have access to view the uploaded source and they can mark the data as reviewed. Our system can then produce a report of what CRFs have been reviewed. The information can also be retrieved via our API.
Source Upload has been in Production for 4 years and is used in registrational and interventional research in the US, Canada and EU. Among others, our system is used on Beat AML (Beat AML® Master Trial For Healthcare Professionals). Beat AML needed the ability to remote monitor source data, due to the inherent complexity of running upwards of 11 simultaneous trials, at over 15 major academic institutions. Safety reviews and critical dose-escalation decisions could not wait!
Obstacle 1 -- Legacy EDC Problem: While a few EDC systems allow Direct Data Entry as “eSource”, none allow the unredacted source to be uploaded. In other words, the site coordinator needs to black out every piece of PHI and it’s very easy to miss some patient identifiers.
Obstacle 2 -- Remote EHR Gateway Access: Some institutions allow remote access to their EHR. It is both a serious administrative headache for the site to review and grant/revoke access to their EHR and many leading academic institutions simply refuse to grant access.
Multiple sponsors have been using our system for 4+ years. For example, on Beat AML® Beat AML® Master Trial For Healthcare Professionals. For more information, here’s an article that was recently published by Clinical Leader:Clinical Operations In The Age Of A Pandemic
To make sure you offer local treatment and basic safety review for your subjects, you may allow them to see their local clinic or hospital. How are you going to collect your key data elements?