Everything You Need to Know for Remote Site Monitoring and Access

To keep your remote site monitoring plan from failing, study site acceptance must be your top priority when designing a remote site access strategy.

This article provides you with tangible tools to support your site’s transition from traditional monitoring (email, site visits, FTP portals, and document vaults) to a cohesive, collaborative, and streamlined virtual experience. 

While COVID-19 introduced a rapid acceleration in sponsor/CRO needs for remote site access, the data we’ve uncovered indicates this shift is not short-term

The tools in this kit will ensure you can rapidly enable remote site access and create a successful long-term strategy to transform your clinical operations model.

Build a Site Communication Plan

A critical component of ensuring your study sites will be successful with a new software solution is how you communicate the change with them.

After you decide to adopt a modern approach to remote site access and select a technology, you need to begin communicating with study sites. From our experience, you should organize your communication plan to support early and continuous dialogue.

For example, depending on your site selection process, it will be helpful to inform sites that you will be providing technology resources to them for the study as early as possible.

This initial discussion is your first opportunity to message how you plan to support and streamline activities so that your sites can focus on patient safety. In the case of providing an Electronic Investigator Site File (eISF) to sites for document creation and management, it is essential to emphasize how an advanced monitoring and site management strategy will significantly reduce the site staff’s burden while enhancing communication.

See the “Implementation and Training” section below for more prescriptive communication pieces and topics as you get closer to initiating your sites.

Download Our Communication Plan Template

Florence Pro Tip: When you partner with a site-centered technology vendor like Florence, they should help you communicate to sites how the solution will benefit them. With an eISF + Remote Site Access solution, the benefits extend beyond a single study’s scope to maximize all of their operations.

    See one example of how Florence welcomes your research sites.

Solidifying Technology Infrastructure

As you put your remote site access strategy into action, you will be making decisions on how your sites will handle things like source data, folder structures, and metadata. For success, you must have a strong understanding of your study sites’ technology infrastructure to make decisions complementary – and not disruptive – to their workflows.

This depth of knowledge of your study sites’ workflows will also help you work with your vendor to design an appropriate training and implementation plan.

After working with over 10,000 study sites in 44 countries to adopt eISF + Remote Site Access, we developed this checklist guide so you can review your study sites’ technology infrastructure and workflow.

Download Technology Information Template

Florence Pro Tip: A vendor with a site-central approach, like Florence, will have the deep expertise ensuring  eISF + Remote Site Access integration into your study sites’ existing and future workflows. With Florence, your remote site access will complement and enhance, instead of disrupting their workflows.

No surprise to you, but the level of IT support each study site has available internally varies drastically. Similarly, your CRA/CTA should not be the technical and training support person for the eISF + Remote Site Access solution.

Work with your vendor to decide how you will collaborate on supporting your study sites throughout the study’s life.

Ensuring Site Compliance

As with all aspects of clinical research, regulatory compliance is critical.

In our experience, sites fall within 1 of 3 categories:

  1. Analog – site operates in a paper-based environment
  2. Digital Collection – site collects documents in an electronic system that may or may not have remote monitoring capabilities
  3. Digital Creation – site has a mature technology stack, including direct data capture capabilities and remote monitoring capabilities

As you complete your technology questionnaires, the above will become evident, and you will be able to maneuver appropriately. An issue to keep in mind: changes to existing site workflows may result in the site needing to modify its SOPs.

Below is the 3-stage process we recommend to sites that are transitioning from paper to Florence. As you make decisions (see implementation and training below) regarding how sites will be required to manage specific study and regulatory activities, this process is beneficial to your sites.

Step 1: Answer Access Control Questions

  • Who?
  • What?
  • Where?
  • When ?
  • How?

Step 2: Execute a Communication Plan:

  • How will you communicate changes over time.
  • What is standard plan for document exchange & ongoing changes.
  • Which scenarios affect compliance?

Step 3: Update SOP Language Including:

  • Acknowledgment of process changes.
  • Identification of which processes, teams, and studies
  • Definition of how these processes are changing
  • Language specific to remote monitoring and doc mgmt.

Florence Pro Tip: Like Florence, a site-centered vendor will assist you in understanding how the decisions you make will impact your site’s compliance. PII, PHI, electronic signatures, and other functions related to being remote-ready require work on the site’s side.

You should not have to work with sites to make these changes. Your vendor should do it for you.

For example, sites making changes to their SOPs, as outlined above, will need to evaluate how to establish language that remains in concert with their organizational standards while adjusting to the needs of your study and long-term workflow changes. Florence provides sites with SOP templates that they can reference as needed.

Successful Implementation and Training

To get your sites onboarded according to your timeline requires a detailed approach that your remote monitoring and site access technology vendor can support.

Below is a list of the decisions you can make now, tasks you will need to complete, and the other areas of consideration for preparing and motivating your sites.

  • Designate your implementation and rollout team and determine which team members will be responsible for topics, such as:
    • Universal configuration decisions
    • System validation and user acceptance testing (UAT)
    • Training content and format
    • New site onboarding process
    • New internal study team onboarding process, if using the system for more than one study
  • Decide which team members will serve as primary points of contact for this project both internally and at the site. This level of staff designation will assist in streamlining communication and should include:
    • Key point(s) of contact between the sponsor/CRO and vendor on a high level across all studies (likely one or more people from the original implementation team)
    • Key point(s) of contact between the study team and vendor — this is usually a CRA/CTA or Study Manager. This person will act as the conduit for specific-study related details and will assist sites in activating your vendor’s technology during study start-up.
    • Individuals who will serve as the “team administrator” at the site for the particular software system
  • Consider what workflows will need to be modified:
    • How will this change the sites’ day-to-day operations? Create a strategy to determine whether you will rollout full system functionality from the start, or take a crawl/walk/run approach to introduce a change to their current processes.
    • Establish work instruction recommendations to remove the burden of sites having to figure out new workflows, especially if the site doesn’t have experience with a remote site access or remote monitoring technology solution.
  • If you plan to mandate eSignatures, ask your sites to send a non-repudiation letter to the FDA for all FDA-regulated studies.

Florence Pro Tip: We provide sites with a template letter, so all they have to do is copy/paste onto letterhead and fill in the blanks. This example underscores how your vendor can provide extra value to you to help your sites be remote ready.

  • Review SOPs and determine required updates regarding electronic document management portals to ensure compliance with regulatory guidelines (see above).

Florence Pro-Tip: Consider offering templated content to sites if SOPs will require updates. Your vendor should assist with this.

  • Develop an internal communication plan to ensure that site staff knows what to expect (see above Communication Plan).
    • Communicate with your sites regarding the vendors/systems they will be using for your study(ies).

Florence Pro-Tip: Your vendor should provide you with marketing materials that include site-specific benefits and information related to how this system will reduce the burden of a paper-based or hybrid environment while enhancing workflows.

    • Sites may already be using another vendor or technology for the same service; establish the expectations for these scenarios.
    • Create an escalation plan for support questions: will you set up an internal support process to triage user questions/issues, or will you have sites contact the remote site access technology vendor directly?
    • Establish an avenue for sites to provide feedback to you, the sponsor/CRO, regarding their experiences with your provided system(s). When you share this feedback with your technology vendor, this furthers the establishment of a true partnership between you, you, your sites, the monitors, and the vendor. It also speaks to ensuring site adoption and usage over time.

Florence Pro Tip: A site-centered remote monitoring solution should address the site burden for managing source documents. For example, Florence ePrinter allows sites to securely and seamlessly print directly into the appropriate folder in eBinders without requiring a monitor to log in to the EHR. This process is fast and straightforward for the site.

    • Evaluate whether access to source data will require involvement from site IT resources.
    • Allow sites to determine how to organize clinical documentation. Using a templated plan can assist with tracking and locating documents across multiple subjects.
    • Consider access requirements as this may affect other decisions: can your vendor accommodate enabling and restricting access to unblinded documents or those containing Protected Health Information (PHI) for specific site user roles?

Florence Pro Tips: Work with your vendor to determine the best training plan. In our experience, role-specific training is the most beneficial and allows users to focus on tasks specific to their workflows. For example, a Principal Investigator (PI) does not need to sit through training to upload documents.

    • Provide sites with reference guides on the new system/technology. Your vendor can collaborate with you on this. Cover basic workflows and serve as a reference available after initial training or as sites add new team members.

Site Adoption

An essential ingredient in your remote site access and remote monitoring solution being successful is site adoption.

While resources we have referenced here will empower you to collaborate with your sites, the bulk of the responsibility for site success falls on your technology vendor.

Selecting a vendor with an established site network utilizing the document exchange system that you plan to deploy is critical. Many vendors have come to the market with solutions quickly and in response to COVID-19 disruptions. Unfortunately, they don’t have the site breadth and depth, buy-in, or knowledge base to support this critical initiative.

The pivot to remote first site collaboration and monitoring is not merely a short-term fix for mitigation of immediate disruptions. Instead, we are at an inflection point for clinical operations. How you utilize innovative technologies like eISF + Remote Site Access for achieving results while ensuring patient safety will make or break your clinical trials.

You want your sites to embrace the technology that you provide and implement them as their go-forward strategy. 

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