Clinical Trial Monitoring | In-Person and Remote

Since 2020, clinical research teams have radically changed how they approach clinical trial monitoring–and researchers need to adapt to this change to avoid being left behind. 

Before the pandemic, the most common type of monitoring was in-person monitoring, where Clinical Research Associates traveled by car or plane to each site to view their documents and facilities. But now, 97% of clinical trial sponsors use technology to review a study’s source data and documents remotely. 

So what does remote monitoring look like? In the past, sponsors and Contract Research Organizations (CROs) often forced research sites to upload regulatory documents and source data into a sponsor portal. The sponsor or CRO would then log into the portal to view the documents. 

But this strategy caused extra work for research sites. Sites had to compile their electronic Investigator Site File (eISF), then re-upload all of those documents into the portal. That’s why, in 2022, 63% of sponsors chose to deploy electronic Investigator Site Files that sites were able to own. Sites could set up the eISF according to their preferences, manage documents and data inside it, and then grant sponsors access for remote monitoring.

In 2023, 78% of sponsors plan to use a site-friendly eISF for remote monitoring. It’s now critically important for sponsors, sites, and CROs to understand how remote monitoring is different from in-person monitoring and how to use remote monitoring most effectively. 

Keep reading to learn more about the different types of clinical trial monitoring and how your clinical research team can use them effectively.

Traditional Clinical Trial Monitoring vs. Remote Monitoring

The traditional method of clinical trial monitoring begins with the Clinical Research Associate boarding a plane or driving to the site. The research site must prepare for their visit by setting aside a quiet room and filling it with paper binders or a computer where the monitor can observe them working on documents.

The CRA reviews as many of the documents as they can during their prescribed visit, leaves feedback for the site, and moves onto the next site. The research site then has to scramble to correct any flaws the CRA found and wait months or even a year before receiving any more feedback.

With remote monitoring, the CRA reviews sites’ documents and data online through a Site Enablement Platform, like an eISF or eRegulatory platform. They then provide feedback for the site, who can quickly incorporate it. When or if in-person visits take place, the CRA can spend their time evaluating the site’s facilities and getting to know the staff instead of sitting in a room and staring at documents.

Types of Clinical Trial Monitoring Visits

Many types of monitoring visits occur throughout the course of a trial, and most of them can be performed remotely. 

Here are a few important types of clinical trial monitoring visits and how they change when they’re remote instead of in-person:

Site Qualification Visit (SQV) 

During this visit, the sponsor or CRO evaluates the investigator’s credentials and the site’s resources and decides whether the site has the ability to conduct a study. This visit takes place after the feasibility assessment and after the site has received a protocol, synopsis, and Confidential Disclosure Agreement. 

The site can provide the information for this visit remotely, saving CRAs from traveling to sites that may not be a good fit for the trial.  

Sites can use a Site Enablement Platform to share:

  • Investigator credentials
  • Site staff and Clinical Research Coordinator credentials
  • Demographics of their patient population
  • Information on their facilities
  • Historical site data
  • Regulatory documents

By sharing these documents through an eISF or eRegulatory platform, sites have control over the story they share with sponsors or CROs–and sponsors and CROs can learn about the site without wasting their CRAs’ time.

Site Initiation Visit (SIV) 

The Site Initiation Visit (SIV) takes place after a site is selected for a study but before patients are enrolled. The CRA uses this visit to give site staff and investigators specific protocol information and to review regulatory forms. 

Parts of the SIV that the site can do remotely include:

  • Signing and submitting regulatory forms
  • Completing protocol and study-specific training
  • Reviewing protocols
  • Setting up logs
  • Confirming the supplies for the trial have been received
  • Communicating with the sponsor or CRO with any questions

When the site performs these tasks online, they won’t have to waste time preparing for a visit about forms and training they’ve already completed. This strategy leads to faster study start-up times.

Interim Monitoring Visit (IMV) 

Interim Monitoring Visits take place multiple times throughout the study–but using traditional methods, CRAs can only visit about one site per week. It would take one CRA an entire year to visit roughly 50 sites–and to make up the difference, sponsors and CROs have to hire more CRAs, a goal rendered difficult by staffing shortages. 

With remote clinical trial monitoring, 75% of CRAs visit 2-5 sites per week, increasing their efficiency for IMVs by 2-5x. 

CRAs can use a Site Enablement Platform to remotely: 

  • Review Drug Accountability Forms, Case Report Forms (CRFs), and logs
  • Access dashboards that show how the study is progressing at each site
  • Assign follow-up tasks

Then, when CRAs perform in-person visits, they can spend their time meeting staff, exploring patient recruitment and experience strategies, and checking on protocols–not reviewing documents.

Closeout Site Visit (COV) 

The closeout site visit, which takes place when a site either completes or withdraws from a study, is one of the easiest monitoring visits to complete remotely. All of the relevant documents and data for closeout will already be in the eISF or eRegulatory platform. The site simply has to make sure they’re complete and send them to the sponsor. 

The sponsor or CRO can then remotely: 

  • Route all relevant documents to the eTMF
  • Archive documents in long-term cold storage for 25 years

Closeout needs to be compliant, but the more efficient it is, the more quickly a trial can be completed and the sponsor can send the results to regulatory authorities.

Benefits of Remote Monitoring

When the Florence team asked sponsors why they adopted technology in 2022, the top answer was to enable remote monitoring and regulatory document access. The number-two reason was enabling remote source access. 

Why have remote source access, document access, and monitoring become so popular? The answer is simple: these strategies save sponsors, CROs, and sites time.

Benefits of Remote Monitoring for CRAs

Clinical Research Associates (CRAs) used to spend 18% of their time traveling. That number only includes time spent on planes or in cars, not time spent on site or reviewing regulatory documents. Remote clinical trial monitoring can save CRAs up to 7.5 hours a week in travel time alone. 

One survey of CRAs showed that without remote monitoring, most CRAs spent more than 7 hours reviewing documents per site. With remote monitoring, most CRAs only spent 3-4 hours of their on-site time reviewing documents. 

But remote monitoring doesn’t only make clinical trial monitoring faster: a survey of CRAs showed that it can also make monitoring more accurate. 

  • 78% of CRAs can move documents into the eTMF faster
  • 76% can monitor sites more often
  • 75% can identify potential risks with site documents earlier
  • 68% can remediate document issues faster
  • 66% can spend less time on repetitive tasks

Remote monitoring also gives CRAs the opportunity to help more of their sites. Without remote monitoring, 52% of CRAs only monitored one site per week. With it, 75% of CRAs were able to monitor 2-5 sites per week–more than doubling their efficiency. To learn more about the role of a CRA, check out our Impact of Remote Site Monitoring on CRAs Benchmark Report.

Benefits of Remote Monitoring for Site Staff

Remote clinical trial monitoring through an eISF or another Site Enablement Platform can also help sites. However, Site Enablement Platforms, like eISFs and eRegulatory platforms, need to match site workflows. 

A fully-equipped eISF or eRegulatory platform can hold: 

  • Regulatory forms
  • Imported source data
  • Logs
  • Informed consent documents

An excellent Site Enablement Platform will also help sites create, edit, and sign documents electronically, establish document workflows, assign tasks to stakeholders, set up users, and give their sponsors permission to view and edit documents. 

Sites will no longer have to manage documents in a paper binder or different software platform, then turn around and upload the completed documents to a sponsor portal–a process that wastes time sites could be spending on patients or essential trial tasks. 

To help you evaluate different Site Enablement Platforms, download our checklist that includes considerations about site workflows and remote capabilities.

Benefits of Remote Monitoring for Site-Sponsor Collaboration

With a Site Enablement Platform, sites won’t have to spend hours preparing for clinical trial monitoring visits by setting up a quiet room filled with binders or computers. CRAs also won’t have to travel to a different city solely to look at documents in an enclosed room.

Instead, site staff can redact any Protected Health Information (PHI) from their documents and data, then give monitors controlled remote access to their eISF (at Florence, we call this feature the Monitor Review Module.) 

Before they visit the site, CRAs can:

  • Look at source data and regulatory documents and leave comments for the site
  • See if the site incorporated needed changes
  • Route documents to the eTMF

Sites can then use in-person visits to get to know their CRAs, show off their facilities, and focus on patient recruitment strategies. 

But if remote monitoring is going to work, it has to be compliant with clinical trial regulations. Luckily, this is possible.

Compliance and Remote Monitoring

The FDA has released guidance that allows centralized remote monitoring, as long as sponsors, sites, and CROs continue to follow all clinical trial regulations. 

ICH E8 R1, the set of international guidelines that many countries rely on when building their clinical trial regulations, also allows flexibility in monitoring, including using centralized remote monitoring. (You can learn more about ICH E8 R1 here.) 

However, sites, sponsors, and CROs who embrace remote clinical trial monitoring will still need to follow electronic document regulations like 21 CFR Part 11 and Annex 11, as well as privacy regulations like GDPR, HIPAA, and CCPA. 

Every Site Enablement Platform should have the following features to ensure compliant remote monitoring: 

  • Document audit trails 
  • Document version control
  • User roles and permissions
  • Digital cold storage of documents and data for 25 years
  • Redaction features for PHI

With a compliant eISF or eRegulatory platform, sites, sponsors, and CROs can turn many of their clinical trial monitoring visits – from Site Qualification to Closeout – into remote visits.

To learn more about how a Site Enablement Platform can accelerate your study while keeping it compliant, check out our remote monitoring case study.

Exploring Remote and In-Person Clinical Trial Monitoring

In-person monitoring can help build connections between sites and their sponsors. But holding every monitoring visit in person forces CRAs to spend almost 20% of their time traveling instead of working on trial-related activities. 

In-person monitoring also costs time for sites, who must interrupt their regular patient care activities to set up rooms, gather documents, or provide access to their computers. 

With a Site Enablement Platform designed for site workflows, sites can maintain their documents and data throughout the trial. Then, when they’re ready for remote monitoring visits, they can simply give CRAs controlled access to their documents and data. 

With remote monitoring, CRAs can check in on their sites whether they’re at the office, at home, or on their way to another site. And trials can keep moving, bringing new treatments to the patients waiting for them. 

If you’d like to learn more about increasing the efficiency of monitoring visits, check out our Complete Guide to Clinical Trial Monitoring, with specific tips on how monitoring can be performed in-person and remotely.