The transition to electronic clinical trial binders (eBinders or investigator site files) is underway across the clinical research industry. eBinders provide several advantages for your site. Well-understood benefits include:
- Improved compliance. Digital binders allow you to easily track and fix compliance issues so that your site is always audit-ready – no paper sticky notes required.
- Reduced workload. Key document prep and eSignature tasks take 40% less time in eBinders.
- Shared access. Multiple-sites, monitors, and compliance teams can collaborate on the same document views.
- Improved revenue capture. Events that require documentation are often billable, and the right system can track and bill accordingly.
Ok then. You’ve decided the transition to eBinders is the right thing – how do you get your sponsors on board? Here’s a six-step set of best practices:
1) Know that you’re in good company: Sites are headed that way. Based on a survey conducted by Florence in 2014, approximately 3 out of every 10 sites made the transition to electronic regulatory management. This share is growing as better software solutions emerge and more sponsors move to paperless studies. Oh, and according to FDA and ICH guidance, electronic study documentation is not only allowed, it’s encouraged.
2) Know you’re in good company: Sponsors are headed that way. A set of mandates for new drug and device applications known as eCTD are coming. These mandates, for both FDA and EMA-regulated studies, require sponsors to submit their master files in 100% electronic format. The first wave of due dates from these regulations are coming in May 2017 (for drugs), the next in May 2018 (for devices). What’s this mean for sites? Electronic document requests and management practices will increase and ultimately become the standard for sponsors.
3) Communicate your SOPs: Although other sites are making the transition, and although sponsors are making the transition, the best argument your site has is through established and confident standard operating procedures (SOPs). Communicating digital SOPs to your sponsor customer and their monitors at the study outset eliminates surprises. Most importantly it is effective at bringing even the most old-school monitor around to the eRegulatory and eSource side of things.
4) Plan your SOPs thoughtfully and train your team. Well constructed eBinder SOPs have the following components:
- Execute a signature non-repudiation filing. If you’re using electronic signatures as part of your eBinder, file a non-repudiation statement with the FDA.
- Build a filing and task index. Articulate which documentation tasks and types are electronically managed at your site, and which are still on paper. As your electronic tasks increase update your index to reflect your progression.
- Evaluate system performance. Is the system you use 21 CFR Part 11 compliant? Show how this is documented.
- Manage security and control. Document how permission-roles are developed and how team members are given access to the tool.
- Train your team. Show that your team is trained up and certified on any electronic system that touches the clinical trial.
5) Make it easy for your monitors. Although we’re all concerned about getting compliance right, this tool should be a relief to use by your monitors too. eBinders gives you and your monitors a “single view of the truth” allowing them to see directly into your site file whether they are across the table from you, or across the world. Just like this reduces workload from your team, it reduces it for the monitor too.
6) Start with the right tool. Florence eBinders was purposely built to make it easy for your site to transition, compliantly, to digital regulatory and source. Plus we partner with you on SOP development and training. To learn more and register for your free demo account, go to our eBinder Product Page.
Pubget, Microsoft, BCG, University of California-Berkeley, Dartmouth College
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