Author: Tiffany Ashton, MAS, CCRA, Director of Clinical Operations at ClinEssentials
Date: June 27, 2022

The Best Tools and Resources for Productive Clinical Trial Monitoring Visits

If you work in Clinical Research, you know that there are different requirements for each type of Monitoring visit. Whether you are conducting a Pre-Study Visit (PSV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV)/Routine Monitoring Visit (RMV), or a Close-Out Visit (COV), each visit comes with its own set of nuances that the Clinical Research Associate (CRA) needs to be prepared for prior to traveling on-site or conducting the visit remotely. When a CRA’s visit goes well, the study can continue to move forward and stay on track for success.

When the goals of a Monitoring visit are not met, there is an increased risk that a Trial will be delayed and/or over budget or Patient Safety may be put at risk. Thankfully, there are ways to avoid unproductive Monitoring visits!

Monitoring Clinical Trials is one of the most important responsibilities for a CRA. With purposeful planning and organization, along with helpful Clinical Trial Monitoring tools and resources, CRAs can flourish in this role!

In this article, we focus on how a CRA can prepare for an Interim Monitoring Visit (IMV) but these tools and resources can be applied to all visits conducted either on-site or remotely by CRAs.

Typical CRA Responsibilities During an Interim Monitoring Visit

CRA responsibilities are based on the type of Visit being conducted. IMVs are the most common visit to occur during a Study’s lifecycle and usually happen every 4-6 weeks, depending on Site Enrollment. Here are the general tasks that CRAs address at an IMV or RMV:

  • Ensure Study eligibility by reviewing the Source documentation, medical records, and Case Report Form entries for all patients, especially those recently randomized. This includes the Informed Consent Form (ICF) collected at Screening, Randomization data, and Follow-up data, as well as Labs, ECGs, and vitals.
  • Perform a review of all reported Safety issues such as Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest.
  • Examine the Investigational Product (IP) and Study supplies.
  • Evaluate Study personnel to ensure all are appropriately delegated and trained to perform Study procedures.
  • Assess the Site facilities for any changes since the Pre-Study Visit.
  • Meet with the Principal Investigator (PI) and other Site staff to review the overall progress of the Study and the CRA’s findings. Provide re-training if needed and answer any questions the site may have.

 The Association of Clinical Research Professionals (ACRP) created this extensive checklist of tasks for a monitoring visit.

 During each visit, CRAs are responsible for documenting everything they observe and discuss. Following the visit, this information is compiled into a Clinical Monitoring Report. Here are 5 guidelines for writing an useful clinical monitoring report from MasterControl.

The Best Tools to Bring to a Monitoring Visit

The Clinical Research Monitoring tools that you bring have a meaningful impact on the success of a Monitoring visit.

Here are the three best Clinical Trial Monitoring tools to have at the Study site – or in your briefcase!

  1. The Visit To Do List Pad makes planning your visit easier. Keep it with you while you are on site to help you stay focused and on task. If you’d prefer to skip the paper, the Visit To Do List is also available as a Digital Download!
  2. Throughout your Monitoring visit, record Action Items on the Action Item Carbonless Pad. At the end of your Visit, leave one copy with the Site staff so that everyone is on the same page for the Action Items that need to be completed. Use the other copy to write your Monitoring Visit Report and Follow-up Letter. The Action Item Carbonless Pad is available for FREE for a limited time: https://clinessentials.com/clinical-trial-monitoring-tool/. Download your copy today!
  3. Last, take your Monitoring a step further with CRA Audit Notes that keep you organized – and give the site staff a visual indication of the tasks that must be accomplished. This simple upgrade from the yellow sticky notes typically used during monitoring help ensure your Action Items are addressed in record time. Along with being one of the best Site Monitoring tools, they also improve communication and effectiveness for Clinical Research teams!

If you are interested in a variety of the Monitoring tools listed above, check out the Bundles that allow you to purchase items at a discounted rate.

These Clinical Trial Monitoring tools alleviate high-stress, nonstop, jam-packed Site visits– making visits more productive, organized, and successful!

Steps for a Successful Monitoring Visit

Being prepared for a Monitoring visit is instrumental to the success of the Visit. When both the Clinical Research Associate and the Research Site are prepared, Monitoring visits run smoothly and efficiently.

With proper communication and a simple 5 step process, preparing for a Monitoring visit does not have to be overly time-consuming. Plus, spending time in advance will be time saved ensuring a productive, organized visit!

  1. Plan the visit. Make sure that your plans are based on the Protocol or directions from the Clinical Research team (Clinical Trial Manager, Lead CRA and/or Sponsor).
  2. Pack so that you are prepared. This free downloadable checklist gives our Top 5 Workbag Essentials and is a great way to simplify your packing and keep you organized.
  3. Review the Study Protocol and have a thorough understanding of the entire document.
  4. Highlight the Action Items. If you have questions or actions needing to be addressed during the visit, try to send them to the site in advance so they can be ready to address during your visit. It is always more effective to discuss and resolve questions or actions items while on site. Once you leave the site it may be challenging to get the site to make it a priority or you will have to review remotely.
  5. Bring Clinical Trial Monitoring tools! (See The Best tools listed above!)

For more tips, check out this YouTube video about how CRAs should prepare for a routine monitoring visit.

Conclusion
As a leader and essential member of the Research team, the Site staff will appreciate and respect you for your thoroughness and organization – and this makes for open communication and a better working relationship!

Introduce your Research teams to the time-saving tools that lead to successful monitoring visits. These same tools can also be used at the site level to keep the trial moving and on the right track in between Monitoring visits.

For more Clinical Trial Monitoring tools and resources that help Clinical Research Professionals become more efficient, visit www.clinessentials.com.

By: Tiffany Ashton MAS, CCRA, Director of Clinical Operations at ClinEssentials

 

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