Group and Organize the Paper Monster
That behemoth regulatory binder binder could definitely be less daunting. Section it out logically by slipping a colored piece of paper or a tab in to demarcate each quarter.
Replace the binder
A new binder is less than $5. If the rings are damaged and every time you flip a page entire chunks fall out or the holes get torn, stop fighting it and replace it. Many of my sites have switched to a plastic bin system and use a hanging folder for each traditional tab. Finally, I can leave my three hole punch at home and making copies for the TMF is now a breeze. Sometimes I just put little colored stickies on the pages I want and I ask the coordinator to fax or scan them to me. When I get back to my office they are waiting in my mailbox and I just ferry them right over to the TMF room.
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| Hanging file folders during conduct are a brilliant way to organize the SMF. |
Don't Put it Off Until the "Next Visit"
Review the correspondence tab at every visit but don't reconcile the old stuff again until the end of the trial at close-out. How do you do this? Just bring a colored piece of paper with you to the site and write “Everything behind this {color} paper was reconciled against the TMF during the monitoring visit on {date}. Attn: Study Coordinator, please file any new correspondence in front of this paper and I will review and file at the next monitoring visit. Thanks! {your name}”. File it at the top of the correspondence pile so the coordinator sees it when they open the binder. Simple, elegant, and it works. Try it!
Other tips?
9 comments:
I carry a small NeatWorks scanner with me when I travel. I can scan the documents directly into my computer while I am on-site so do not have to either copy it or have it faxed to me. This makes submitting the e-Docs to the TMF a less odious chore. The scanner also helps me keep up with expense reports, as I scan the receipts at night and throw them away...no more paper receipts to manage at the end of the week.
@Lainey, you're kind of like a CRA super hero with your neatworks scanner. We have some at work and I have begging the IT guy to procure one for me. I need to start bribing him, I think!
Hi Nadia! First time visiting your blog. I'm not a CRA, but your tips can also be applied to to other aspects of research, like the CRC work.
I'm with Lainey, I'm a paperless person...but I also do a back up of the important documents in an external hard drive...in case the computer crashes.
Thanks for your tips!
Good point! Backing up the laptop is really important. I am on my third laptop in six months. Thank goodness I back up the data regularly to the share drive. We recently upgraded at work to Windows 7 Enterprise and the new Microsoft 2010 Suite. I have drafted a series of blog posts about the transition and I hope to edit and post soon for all you CRA (or other) geeks.
Where and how much is this neatworks scanner?? Sorry, i am not from the US so i dont know all this.
Hi Autumn, I've seen the NeatReceipts for sale at kiosks in the airports. You can also get them on the internet (NeatReceipts Mobile Scanner and Digital Filing System) but they are quite dear at nearly $200 USD. Check on the internet and read reviews for similar products like Doxie or other mobile scanning solutions. This is on my wishlist but I don't own one. I'll keep shopping around for now.
Quick question - when you say you reconcile with the TMF - do you ensure that they match exactly? For example, the site might have filed emails that you don't think are relevant and haven't added to the TMF. Would you remover those from the site file? I'm always unsure about this! As its their site file and its hard if they want to file everything! Thanks.
Thanks for a great question. If the site filed items that are not required by the regs, you are not required to retrive them. I actually did an entire post on this year before last because it is such an interesting topic of discussion: The Correspondence Tab in the Site Master File
My best advice would be that if you are in doubt you should definitely make a copy. Then when you get back to your home office you can check in with your Lead CRA or regulatory document person to see whether or not to submit to the TMF. If not, you will be able to confidentially shred the document and move on. If you needed it and did not take a copy the TMF will not be complete until you retrieve it and that can be annoying for you and the coordinator as well as time consuming.
I would never modify a Site Master File other than adding tabs or colored paper dividers without first requesting permission from the coordinator. I do not own the site file and I do not feel entitled to remove things but I will flag items and discuss them with the coordinator if they do not belong there (a doc for another sponsor's study, an audit report, etc.). I will reorganize a binder if I have received permission but I always sit with the coordinator afterwards and walk them through the changes I made so that they can still find their important study documentation filed under a different tab.
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