Written by Nicole M. Palmer, Edye T. Edens and John R. Nocero

 You just received a vendor invoice and were asked by upper ward management to file it in the Trial Master File. The study is still new, and a Trial Master File plan has not been created. The sponsor has requested that you use Dropbox to file the essential documents. They didn’t want to use XYZ eTMF vendor because they wanted to save on cost. They have agreed to use the latest version of the TMF Reference Model.

You check your SOPs and Working Practices, and it is not clearly defined, however, in the past all financial documents have been kept by the Finance department.

Sound familiar? If you’ve ever been in this situation, you know what we are talking about.

Here are a few things to consider. Is Dropbox 21 CFR Part 11 Compliant? Did you validate it? Can you control the permissions on the 11 Process Zones and the sub-folders?

The TMF Reference Model section 05.04.07 Financial Documentation, column ‘I’ states Recommended, “recommended meaning the artifact does not have to be produced but if it is created or collected, it is recommended to be in the TMF.” One thing to remember is, that the TMF Reference Model is not the law. You don’t have to “house” all the documents in your electronic system.

Edye, you have a law degree, what are your thoughts on this?

Whew, so much to say here about these situations Nicole, thanks for asking!

While I fully recognize the somewhat ‘hostage situation’ Sites play in these scenarios, I always remind research Sites that at the end of the day, the research is taking place at YOUR Site, and it is ultimately YOUR responsibility and YOUR liability to pay. Often leadership falls prey to the common belief that the Sponsor bears the liability and thus has the right to bark orders and know everything happening at the Site level. 

As a Site, I would initially respond to leadership, gently, by pointing out that it’s neither the norm nor advisable to begin placing our financial invoices into the TMF, whatsoever. Study budget, absolutely, but not actual invoicing and paid documentation. By keeping it with your Finance Department, you’re following the norm and keeping Site info confidential, as it should be, and not a part of the TMF.

I’d also advise senior leadership you should have clearer SOPs around how these otherwise financial and not study-related documents should be housed and who has access to them so you’re transparent with your process and Sponsors are aware this is how it will occur. The Sponsors and any regulatory agency can only assess you against the policies that you document in your Site’s process!

As for the Sponsor’s request to use Dropbox, I’d request of them exactly what would be requested of the Site in any routine audit – proof of the compliance Nicole alluded to above regarding Part 11, validation and permissions, before you can begin using this in ANY way for sensitive TMF documentation. And I’d push hard, as the Site, that it is NOT your job to initiate these steps for compliance, it is 100% on the Sponsor… the Site may have a role in assisting, but not spearheading these activities as it isn’t the Site mandating the use of this technology.

 What do you think John? Am I being too harsh, haha?

 Edye and Nicole-I never think it is a case of being harsh. To me, you are in business to make money and/or keep the money you have. Cost is important. I don’t know if that is harsh but it is realistic. I agree with you – it is the site’s responsibility at the end of the day to ensure everything at their site is done in a compliant manner. Ultimately, sponsors need to do a better job in vetting sites. It’s like dating. You need to vet your person for any red flags. Too many times, people go on a first date, and they quickly move to what the house is going to look like, how many kids are we going to have, what they’ll wear on their wedding day and the other person is like, “let’s just see if today works.” That’s what sponsors need to do – let’s just see if today works with the site.

Clearer SOPs, using Dropbox, etc. are all admin functions that can be discussed, but what can’t, is whether or not the site will be compliant. If not, like dating, it is better to cut it early and find another person, or site, that will work better for you.

As always, if you have a question or want to leave a comment, please feel free- We are happy to help and love to hear from you.

References:

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11

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