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