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Compliance In Focus
Posted by Stephani Hulec on Tue, Jan 19, 2021

11 Clinical Monitoring Skills Your Team Needs Now

 

The way many teams conduct clinical monitoring has been evolving for years, but the pandemic certainly accelerated the pace of change.

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In a recent survey IMARC conducted of over 100 clinical research investigators and associates, 64% said they never or rarely conducted remote monitoring visits prior to the COVID-19 pandemic.

Today, nearly 60% said they are now doing so frequently, and almost 30% said they sometimes conduct remote monitoring.

Additionally, 73% believe a hybrid model that uses both remote and onsite visits will be the best approach in the future.

To keep up with these changes, today’s clinical research monitors need new skills and competencies, but as we’ve seen over the past two decades, the fundamentals are just as important as ever.

Here’s a closer look at what we believe are the most in-demand monitoring skills today.

The Top Clinical Monitoring Skills

 

1. Knowledge of Good Clinical Practice and Federal Regulations

Some skills will always be important no matter how much a monitor’s roles and responsibilities evolve, and the ability to understand and apply Good Clinical Practice (GCP)  is one of them.

Good Clinical Practice covers everything from medical device regulatory requirements to human subject protection and informed consent. In addition, having a strong working knowledge of the applicable Federal Regulations is crucial to ensure monitors are identifying and addressing compliance issues appropriately.

While the fundamental principles have been in place for over 50 years, regulatory agencies have introduced new guidelines as additional considerations have emerged. Best practices for obtaining informed consent via electronic signatures is just one example.

2. Critical Thinking

There is a big difference between knowing the regulations and understanding how to apply them when the answer isn’t always obvious. For instance, what should a monitor do if data from an original source contradicts what is in another document?

At IMARC, we have developed our own training course to help monitors develop critical thinking skills. Known as the FAIR Shake™ Method, it uses an acronym to navigate the four main areas of regulatory compliance:

  • Federal regulations
  • Agreements with the sponsor
  • Investigational plan
  • Requirements of the Institutional Review Board (IRB)

This exercise in critical thinking ensures that monitors can answer questions with confidence and are consistently taking it back to the "why" when providing recommendations to their sites and/or sponsors.

3. Flexibility

The pandemic has forced all of us to adapt to a new level of flexibility, and monitors are no exception. They need to juggle multiple projects (including completion of on-site and remote tasks) and pivot when necessary. For instance, if conditions/local policies change, your team may decide it makes more sense to move to remote monitoring instead of completing an on-site visit. When this occurs, monitors need to be able to work through the logistics to ensure any monitoring activities that are able to be completed remotely are done so in a timely manner.

Today’s monitors need to be able to adjust to changes as quickly as they happen—a skill best acquired through experience.

4. Risk-Based Monitoring

In the past year, increased reliance on risk-based monitoring came mostly out of necessity, but it has prompted many clinical research teams to re-evaluate some of their processes. They’ve discovered that in-person visits may not always be necessary, especially in a low-risk medical device trial.

Instead, many sponsors are considering whether taking a hybrid approach that includes both on-site and remote monitoring activities is the best long-term solution for their studies.

Understanding how to apply a risk-based monitoring strategy can help monitors invest their time and effort where it will have the greatest impact.

5. Hosting Remote Monitoring Visits and Protecting PHI

Monitoring visits aren’t necessarily easier or less time-consuming just because they are hosted remotely. They often require some additional preparation, use of new technology, and sometimes more follow-up.

In our survey, 32% of respondents said remote monitoring significantly increased prep time, while another 25% said this time has slightly increased. Respondents were similarly divided when it came to the amount of time they spent conducting remote monitoring visits. Over half said it required significantly or slightly more time than in-person visits.

Some remote monitoring is likely to remain a standard part of the clinical research process in the future, so learning how to conduct these visits efficiently is one of the most important clinical monitoring skills moving forward. In particular, monitors need to know what steps to take to protect personal health information (PHI). Monitors must work with each site to obtain access to health records containing PHI through the necessary individual requirements and ensure that safeguards are in place to keep these documents confidential when reviewing these remotely.

6. Writing an Exceptional Monitoring Report

As we often say in clinical research, if it wasn’t documented, it wasn’t done! To maintain patient protection and data integrity in your trial, your monitors need to know how to write an exceptional monitoring report.

Your monitors should review the monitoring plan before the visit to ensure the visit is conducted in compliance with this plan and that details of the visit are appropriately included in the report documents.  During the visit, they should fill out the report with as much detail as they can, highlighting any areas that require additional follow-up. All of this requires experience and extraordinary attention to detail.

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7. Writing Effective Data Queries

A big part of every monitor’s job is to identify discrepancies between the data and the source and appropriately resolve them. Monitors need to know how to write effective data queries to obtain the information they need to resolve these discrepancies. That includes using proper grammar and spelling, noting the appropriate source, and clearly explaining any questions or discrepancies. Anyone who reads these queries should be able to easily understand them, even years after the trial takes place.

8. Documenting adverse events

Reporting serious adverse events is an essential part of any clinical trial. However, the FDA regulations leave some room for interpretation when it comes to how to report them. Monitors need to know the difference between life-threatening adverse events, serious adverse events, and unexpected adverse events and the various ways to determine how these should be reported to the Sponsor and/or IRB.

They should also understand the process for involving the Principal Investigator, Sponsor, and Clinical Events Committee (CEC).

9. Safety monitoring and oversight

Although your clinical trial may have a Data Safety Monitoring Board (DSMB) and/or CEC for safety oversight, your monitors need to be familiar with the goals of safety monitoring and recognize when events require further review, and work with sites to ensure any information necessary for DSBM/CEC review is submitted in a timely manner.

10. Ability to collaborate with vendors and other research associates

As clinical research becomes more complex (especially when it comes to medical device trials), they typically involve more vendors and team members. Monitors need to understand the role of all parties involved and the best way to collaborate with each.

This includes providing them with the information they need in a timely manner, requesting or verifying information from them, and offering objective oversight.

11. Audit preparedness

Whether it’s remote or on-site, preparing for an audit requires extra time and attention. BIMO site inspections are among the most common types. Fortunately, the FDA provides detailed guidance on what they cover and how to prepare for them.

Other types of audits include Sponsor trial master file (TMF) audits and vendor audits. A well-trained monitor is able to guide their Sponsors and/or sites with confidence ahead of and during any type of FDA inspection.

Help Your Monitors Succeed With Clinical Research Training

Well-trained monitors can be hard to find for several reasons. Turnover rates tend to be high compared to other roles, due to high expectations, travel burnout, a steep learning curve, and a desire for higher pay. While the FDA states monitors should be trained, it does not specify what that training should entail. Monitors often come from a variety of different medical and scientific backgrounds, so they may have their own processes for conducting visits and writing reports.

Training that is based in the regulations and not personal preference can help your monitors achieve the right skills and follow a consistent process.

IMARC provides a variety of in-person, virtual, and hybrid clinical research training courses specifically for monitors through IMARC University. These courses cover all skill levels, from the fundamentals of Good Clinical Practice to more advanced sessions designed to improve critical thinking. Our courses are hosted by experienced monitors who share real-life scenarios and use a variety of interactive formats to improve the learning experience and information retention.

Download our course catalog to see how we can help your monitors develop the skills they need to succeed.

And, if your team lacks the in-house expertise or the time to conduct your own monitoring, learn more about how we can help.

Topics: Clinical Monitoring

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