Remote Site Monitoring During COVID-19 Clinical Trials: Tools and Processes for a Flexible and Adaptive Approach

News / TRIbune Newsletter

Existing Remote Monitoring Methods

In 2013, the U.S. Food and Drug Administration (FDA) issued an industry guidance document encouraging a shift to risk-based monitoring, with specific recommendations for using remote monitoring and other alternative techniques more often.¹ Despite the initial recommendation and recent FDA encouragement for remote monitoring, the existing tools and processes present some challenges.

To conduct remote site monitoring and source document review, most sites rely on using email, fax, and local cloud-based systems, or providing the monitor with remote access to the Electronic Medical Record (EMR).

Email or Fax
Although using email or fax offers a relatively quick option to transmit information, each requires the additional administrative burden of redacting all Personally Identifiable Information (PII). Therefore, using these methods limits which documents and associated content may be sent for review, and increases the risk for human error and missed redactions. This approach also places an added burden on the monitors and clinical research associates (CRAs) to create a system or process for filing and organizing the documents for review.

File Sharing Systems
Alternatively, sites may use local cloud-based file sharing systems to upload source documents for remote review. Although this method may offer greater organization of files shared in a single location, most systems do not comply with the FDA’s Code of Federal Regulations (CFR), 21 CFR Part 11,² and still require redacting all PII before uploading a file. As such, sites have the added administrative burden of requesting access for monitors, as well as completing the document redaction. These systems also typically do not maintain an audit trail of activity for each document, nor do they support ongoing system validation and security documentation.

Remote Access to the EMR
Another approach is to provide monitors remote access to the site’s EMR. This method allows monitors direct access to unredacted source information, which eases the burden on sites as well as monitors. However, this method typically requires an access agreement and, possibly, consultation with the sponsor and contractor legal teams. This method also typically is used with another approach, such as email or file sharing, to review documents (e.g., regulatory, pharmacy study product accountability logs) outside of the EMR.

SourceVu: A Secure and Streamlined Remote Monitoring Solution

In response to the pandemic, and to support our clients’ remote site monitoring needs, Technical Resources International, Inc. (TRI) developed a secure, user-friendly, and adaptable remote monitoring platform called SourceVu.

SourceVu is a customized software system that allows site staff to upload documents quickly and securely for CRAs to review during remote monitoring visits. SourceVu complies with 21 CFR Part 11, the European Union’s General Data Protection Regulation (GDPR),³ and Good Clinical Practices (GCP).⁴ This secure portal enables source data review and verification, including subjects’ Informed Consent Forms, medical records, pharmacy study product accountability logs, and any other records, as needed.

Secure

SourceVu is a validated system that uses role-based security to restrict access to documents based on user role and document type.
Document distribution restrictions are included to further protect PII.
Once the remote monitoring review is complete, the uploaded documents are permanently deleted from the portal.

User-Friendly

Upon signing into the system, users have quick, convenient access to their assigned protocol and site folder for easy upload of documents. Users do not need to organize files or create a folder structure; they simply sign in, select their protocol, and upload documents.
SourceVu does not require redacting PII, thus facilitating streamlined and efficient document upload and review.
Monitors benefit from access to a comprehensive audit trail, which tracks when documents have been uploaded, reviewed, and deleted from the system, as well as the date, time, and user associated with each action.

Adaptable

SourceVu provides separate folders and access restrictions to facilitate both blinded and unblinded information upload at each site.
The system offers a built-in certified copy feature, allowing site staff to attest that the uploaded source document matches the original.
SourceVu offers additional features users can customize to meet each client’s specific needs.

Benefits of Remote Monitoring: Reduced Costs and Improved Efficiency of Operations

On-site monitoring typically is the most expensive component of conducting a clinical trial, comprising 25%–30% of total costs.⁵ However, remote site monitoring systems, such as SourceVu, allow sponsors to reduce clinical trial costs and conserve resources, thus maximizing the speed and quantity of trials that can be conducted.

With remote monitoring in SourceVu, monitors can switch from review of one site to another in seconds, removing the time and costs of cross-country travel to review source data at different sites. Less travel time can result in more time spent thoroughly reviewing the data, interacting with the sites, and conserving staff and overhead resources.

On-site visits also are dependent on scheduling availability and require prespecified dates and times for the review and completing the visit. Using remote site monitoring does not have that limitation; it offers a flexible approach that permits sites to upload documents at their leisure in preparation for a remote “visit”, and monitors to complete the review without date, time, or location limitations. With the rapid participant accrual rate and volume of data collected under some COVID-19 trials, monitoring visits may be required every week for some sites. Remote site monitoring methods can accommodate this frequency using a low-cost, efficient approach.

Supported by recent FDA guidance on the conduct of clinical trials during COVID-19,⁶ the industry is encouraged to shift to greater use of remote site monitoring. TRI is proud to support our clients in this effort through a variety of services, including customizing successful use of SourceVu, a flexible, adaptive, and cost-effective remote monitoring tool.

Footnotes

U.S. Food and Drug Administration. (2013). Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring

U.S. Food and Drug Administration. (2013). Part 11, Electronic Records; Electronic Signatures — Scope and Application.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

GDPR.EU. (2018). General Data Protection Regulation.
https://gdpr.eu/?cn-reloaded=1

International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use. (2016). ICH harmonized guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) ICH Consensus Guideline.
https://ichgcp.net/

Branch, E. (2016, April 30). Ways to Lower Costs of Clinical Trials and How CROs Help. American Pharmaceutical Review.
https://www.americanpharmaceuticalreview.com/Featured-Articles/185929-Ways-to-Lower-Costs-of-Clinical-Trials-and-How-CROs-Help/

U.S. Food and Drug Administration. (2020).FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency

About the Author

Dr. Jessica S. Ellis is a Clinical Project Manager at TRI, who has a PhD in Neuroscience and Cognitive Science. As TRI’s Business Owner of SourceVu, she provides management support and oversight to site monitoring teams across a variety of clinical trials and therapeutic areas.