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Home-Office Best Practices – Security in Mind

1. Password and 2FA/MFA protections. If using a home internet network, be sure to password-protect access to your internet and if needed, update your password e.g., your house address or dog’s name are still not secure). When possible, setup two-factor authentication (2FA) or multi-factor authentication (MFA). This protects your devices and the data processed on them. It can be hard to remember passwords from home. Unless your organization has approved the use of a password manager, don’t use them! Although it may be tempting, you don’t want to lose all passwords to a hacker!
2. Virtual Private Network (VPN). Ask your IT Department about setting up a VPN, which extends the private network to you. This ensures that the data you send and receive are protected in transit.
3. Secure phone line. If you don’t have a work phone, establish boundaries with colleagues and patients on how to reach you by voice. Set work hours. Clarify with your organization/IRB regarding the terms of use for outbound communication with patients/research subjects (e.g., specific HIPAA apps; texting; in the US, dialing *67 to block your number, etc.). Get guidance before making a mistake!
4. Device locks. Just like at work, lock your device screens when stepping away. Neither your family and nor a stranger walking past your window should have the opportunity to view information your device screens (not to mention, it only takes one toddler or pet’s inopportune step to delete something accidentally).
5. Internal resources. Check with management on best practices. Many companies are issuing organizational logistics and even hotlines for questions. Take advantage and save your management headaches by finding and reading those resources.

Home-Office Best Practices – Clinical Research Studies and Trials in Mind

1. Calendars and (remote) visit schedules. Map out what is due (regulatory and subject study visits) and be prepared on how to resolve which ones will and will not occur.
2. Anticipate protocol violations/deviations. Be proactive and make a plan. Many assessments will not be able to be performed. Keep track and properly document. In these high-stress times, it will be very challenging to remember some of the details as time passes. Don’t forget to reach out to your sponsors and IRB for additional guidance and expectations.
3. Email communications. Your teams may see a rise in email correspondence to simply discuss daily topics that would otherwise occur while in the office. Don’t fall behind on keeping track of the relevant, study-specific correspondences that need to be filed for the study. Continually ask yourself – “Would this email help connect the dots and/or explain why things are how they are to someone who knows nothing about the study?” If the answer is maybe, save it and file it with in the regulatory binder. You will thank yourself later.
4. Certified Copies. If your team intends to convert paper documents (or other media) into digital certified copies, be sure that you have an approved SOP in place that covers the procedure. Unless directed otherwise, we suggest that all scanning takes place at your organization as opposed to transferring paper documents into your home. For additional guidance, refer to the FDA, EMA, and ICH.
5. SOP management. If your organization is considering any procedural or operational changes to accommodate home offices, be sure that you have approved SOPs in place to comply with your regulatory body’s requirements for electronic records and signatures (e.g., US FDA 21 CFR Part 11). For example, if you plan to move to an eRegulatory system, we encourage that you cover the following topics:
   • Definitions – update terms related to eRegulatory (Audit Trails, Electronic Signatures, Electronic Records)
   • Access Control – cover who is responsible for inviting users, creating roles, and granting access.
   • Password management – going digital can mean more passwords! Do not reuse the same password and make it easier for a hacker to log into all of your accounts. Instead, check with your IT department for an approved password manager. These systems make it really easy and secure to use auto generated and very complex passwords that you don’t have to remember. Also, many have browser plugins that make it even easier (so long as you lock your devices!)
   • Legacy Studies – describe how pre-eRegulatory files will be managed.
   • Certified Copies – will the eRegulatory system be used? Are any documents out of scope that should not be converted?
6. Study-specific training and documentation. Are you in need of additional support? Before getting help from another teammate, be sure that they complete their study-specific training, complete financial disclosure forms, FDA 1572, and update the DOA logs before helping out.
7. Trial cheat sheets. In high-stress times, it can be easy to mix up study requirements. If possible, put together cheat sheets on basic information about a study that will help your team:
   • Sponsor/CRO contact information
   • Enrollment status: open, closed-to-accural
   • Key Eligibility Criteria: the top 3-5 criteria, not the common ones
   • Intervention/cohort: in a few words, remind us of the treatment schedule
   • Visit schedule/assessments: it’s easy to lose track, help us remember
8. Follow the regulatory news. For US research teams, the FDA has been posting guidance to support Industry, Investigators, and Institutional Review Boards – here. The ACRP continues to share relevant blogs and tips on COVID-19.
9. Connect with the community. There are many resources (including asking the Sponsor to connect you with other sites) to learn how they are adapting. Florence offers a Community Page, ACRP offers a community, and there are other ways to connect with clinical research professionals.

Feeling rusty on your eRegulatory software functionality? Follow these tips!

1. Access Control. If you manage your team’s eRegulatory software, be sure the right team members have access and that each person’s role aligns with the access and permissions they may need when working remotely.
   • For example, maybe your monitor/CRA sent an email that they are restricted from traveling for the foreseeable future. Determine if it’s appropriate to extend their access to conduct additional remote visits and/or leverage QC collaboration tools.
2. eSignatures. Run reports and catch up on records with pending signatures. Now is a great time to catch up.
3. SOP Review. Depending on your team’s new home-office situations, it is worthwhile reviewing your SOPs to identify potential risks. Review and determine if any violations have occurred.
   • For example, do you have an SOP that states a record will be signed wet-ink handwriting within three (3) business days?
   • Are there other constraints that you might be violating given the current situation?
   • Are you up to date on password management?
4. Basic eReg training. If you have downtime, now is a great time to learn about new features that you might not have had time to take advantage of. If you’re using Florence eBinders, eTMF, or eHub, be sure to log into our Help Page and watch our recent Office Hours! If you’re feeling friendly, share highlights with your research team and/or send them links to our basic training.
5. eReg Spring cleaning. If you have downtime, reexamine your workflows to adjust to the new normal and be sure to leverage the tools at your disposal. You may identify ways to be more efficient and/or challenge workflows that simply don’t work anymore.

When in doubt, think of the urban combat chaos that our Special Forces have experienced and keep their slogan in mind: “Slow is smooth. Smooth is fast.” The world is fighting this together.

If you have any questions about staying compliant at home, please reach out to us at compliance@florencehc.com. We are here to help.