Many Clinical Research Associates are unprepared for their clinical trial monitoring visits, which is an important part of their role. It is understandable – CRAs are busy and it can be hard to find time for planning where there are so many other tasks to complete right away.
Monitoring visits are when CRAs ensure their studies are staying in compliance and on track. Creating a plan for the allotted time is the best way to ensure a productive, efficient monitoring visit.
What Happens at a Clinical Trial Monitoring Visit
Monitoring visits are typically very full days – jam-packed with all of the action items the CRA and the site need and want to accomplish.
A CRA may visit a site for site initiation, an Interim Monitoring Visit (IMV) – also called a Routine Monitoring Visit (RMV), or a study close-out. IMVs are the most common and usually happen every 4-6 weeks. However, monitoring plans differ and are determined by the Sponsor or CRO before a trial begins.
3 objectives of a monitoring visit
While there are many things that a CRA wants to successfully complete at a monitoring visit, there are three main objectives for each visit:
- Discover any data errors and/or discrepancies
- Evaluate the site staff’s understanding of the protocol and procedures
- Determine compliance
Standard tasks, meetings and goals of a monitoring check-in visit
Tasks are based on the reason for the visit. Since an Interim Monitoring Visit is the most common, here are the general business items that a CRA will address at a monitoring check-in visit:
- Review the regulatory binder, study documentation, and CRF entries
- Audit screening, enrollment, visit, and follow up data
- Conduct Source Data Verification
- Perform a safety assessment
- Examine the investigational product and study supplies
- Evaluate study personnel and site facilities
- Meet with the Principal Investigator and site staff
The Association of Clinical Research Professionals (ACRP) created this extensive checklist of tasks for a monitoring visit.
CRAs are responsible for documenting everything they observe, notice, and discuss during a visit. Following the visit, this information is compiled into a clinical monitoring report. Here are 5 guidelines for writing a useful clinical monitoring report from MasterControl.
Consequences of being Unprepared for a Monitoring Visit
Being prepared for a monitoring visit is instrumental in the success of the visit. When both the Clinical Research Associate and the research site are prepared, monitoring visits run smoothly and efficiently.
The patient volunteers, clinical research team, and CRO or Sponsor are all negatively affected when the CRA or the site staff has not taken the time to prepare for a monitoring visit.
Scheduling conflicts and unavailability of key team members can lead to important meetings that have to wait until the next visit.
The site may not have the necessary documents or the regulatory binder ready for the CRA to review, which is one of the primary activities for most monitoring visits.
When monitoring visits are not successful and all essential tasks and meetings do not occur, the trial can be delayed – and potentially over budget. Sponsors and CROs may lose trust in the site and the staff.
3 Steps for a Successful Monitoring Visit
With proper communication and a simple 3 step process, preparing for a monitoring visit does not have to be overly time-consuming. Plus, spending time in advance will be time saved through an efficient, organized visit!
- Plan the visit. Download this free checklist that will lead to a well-planned visit. It even includes a list of documents to have on your computer and in your work bag. (The checklist can be modified based on the protocol or directions from the research team.)
2. Review the study protocol and have a thorough understanding of the entire document.
3. Bring clinical trial monitoring tools! Use the Visit To Do List to stay focused and on task. Provide the site staff with a copy of the Action Item List – and use the other copy to write the Monitoring Visit Report and Follow-Up Letter.
For more tips, check out Dan Sfera’s YouTube video about how CRAs should prepare for a site monitoring visit.
Stop showing up unprepared for a 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 will be evident in their work!
For more great ideas and monitoring tools that help clinical research professionals become more efficient, visit www.clinessentials.com.