Your Florence Expert

Amanda Korey Headshot

Amanda Korey
Implementations Manager

To mitigate disruption from COVID-19, clinical trial sites and sponsors are turning to remote document access and management platforms.

For research organizations that have made the shift to eISF platforms like Florence eBinders, this is a relatively simple step. However, for research organizations maintaining paper-based or on-site records, this transition to remote work and remote monitoring is resulting in significant challenges.

Those organizations are now searching for ways to send, manage, store, review, and access clinical trial documents remotely in a secure and compliant way.

When exploring these electronic document management solutions as a short-term fix, it is essential to have an understanding of Part-11, HIPAA, Annex-11, GDPR, and other relevant regulatory requirements.

Below are some quick tips to check your electronic document management solutions have the high standards, security, and regulatory compliance clinical research demands.

  • Ensure the platform you use supports the compliance framework relative to your research – FDA 21 CFR Part 11, Annex 11, HIPAA, HITECH, ICH GCP and GDPR.

  • Ask your vendor for support on validating for FDA 21 CFR Part 11. They should be able to provide you with their technical validation as well as direct you on how to validate the administrative and operational requirements.

  • Confirm that audit trails are available for all actions in the tool – especially if used for advanced workstreams like eSignatures.

  • Check that the system has advanced permission controls allowing you to control who can view, create, edit, and manage individual documents and folders.

  • Decide if you will store any documentation with PHI and ensure your document management vendor has tools in place for this such as redaction or user permissions that can exclude or include certain individuals from viewing a particular document with protected information.

  • Certify that in the event of an audit, each document can be easily located and reviewed, in other words, that it doesn’t encumber this process.

  • Make plans to update your SOPs to cover how your operations will change with the cloud.

  • Determine if you will use advanced workflows like eSignatures (if available) and if so, be sure to file a non-repudiation letter to the FDA and also collect additional testimony from each user that their eSignature is the equivalent to their wet-ink handwritten one.

When selecting a platform, it is crucial to think both short-term, what can get us operating fast, and long-term, what can we use as a foundation for ensuring future success.

Electronic document storage and access are the first steps in a remote research management plan. Building a long-term remote collaboration plan is vital as the industry looks to ensure clinical trials continue to operate at maximum capacity.

Download our guide to building a remote strategy while mitigating operational disruptions here.