Many of my friends in the industry know that I have strong feelings about not including eCOA screenshots in IRB/EC/Regulatory submissions.
Our industry colleagues Stephen Raymond(RIP), Bill Barrasso, Art Gertel and A Hackett started the process in 2016 with their first publication. This article suggested a different approach that would address the legitimate concerns the IRB/EC/Regulatory Authorities have.
Raymond S, Gertel A, Barrasso B, Hackett A. Optimizing Electronic Clinical Outcome Assessment Materials Required for IRB/EC Review. Medical Research Law & Policy Report. 2016; 15 MRLR 159.
In 2020 our colleagues in the eCOA Consortium followed up with another article to reiterate that screen shot submissions are not the best solution and that there are other means to protect clinical trial participants.
Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?
https://lnkd.in/eNzMguxJ
In our daily work with eCOA Partners and Sponsors we experience the unnecessary delays and pressures the current process causes. When we only saw little or no adoption of these alternative approaches, we decided in 2021 to tackle this issue from another angle. We generally believe that people in the industry are trying to do good work and to support the development of safe and efficacious treatments.
With this in mind we decided to approach IRBs to find out if they knew what burden they put on the eCOA teams by requesting these screenshots.
We knew someone at Advarra and after a brief introduction we got right into the topic with James Riddle and found him very open to finding a better solution.
Advarra has now published their new “IRB Handbook v6” and “Recruitment and Subject Materials Guidance For Clients“ and included very clear instructions that they do not require eCOA screen shots anymore!
A BIG THANK YOU to everyone who contributed along the way. There is more education needed and we need to spread the word. Please share this post within your network.
Safira Clinical Research Limited‘s contribution to this process started with five phone calls. Every contribution is valuable and can help to “move the needle” in the right direction.
My colleagues at Safira Clinical Research Limited and my Co-CEO Gauri Nagrani challenge CROs and IRBs/ECs daily and we encourage everyone to do the same. It works!
Today we celebrate 🎉 , progress has been made 👍 …….. and tomorrow we will be making another phone call. 😂
