A clinical monitoring visit is an important step to ensuring a study is maintaining compliance and staying on track.
These days, more sponsors are supplementing on-site visits with remote monitoring. Regardless of the format, what happens before and after the visit is just as important as what happens during it.
As monitors, we spend a decent amount of time preparing for the visit – before we even head out the door. On the road, we’ve noticed that the most effective site coordinators tend to be those who also prepare for the visit. Spending an extra hour or two before the visit can decrease the amount of queries, follow-up items and even the length of the visit itself.
Here is a short overview of what research coordinators can expect from a clinical trial monitoring visit and five steps they can take to prepare.
What To Expect From A Clinical Monitoring Visit
A clinical monitoring visit typically has several objectives, according to the FDA. Those objectives include:
- Identifying data entry errors and discrepancies
- Assessing the site staff's understanding of the protocol and procedures
- Assessing compliance
During an on-site monitoring visit, monitors typically review study documentation to ensure it meets best practices. For instance, is it attributable? Legible? Comprehensive? Original? Accurate? Complete?
The ALCOA-C checklist is a good guideline to remember as sites prepare for a monitoring visit.
Monitors will also observe site operations, such as enrollment and follow-up, and see how responsibilities are delegated and how the study is running. Depending on the type of monitoring visit, they may be focused on specific actions, such as site initiation, periodic check-in or study close-out.
The FDA also encourages remote monitoring, also known as centralized monitoring, especially during the recent COVID-19 pandemic.
With remote monitoring, the monitor reviews electronic records to achieve many of the same objectives, including identifying data discrepancies and compliance issues. The types of remote monitoring activities may vary but could include follow-up via email, phone calls or video.
Sites: How To Prepare For A Clinical Monitoring Visit
Being well prepared will help you make your next clinical monitoring visit as efficient as possible. Sites should follow these steps to make sure everything is in order.
1. Review Data Entry
First and foremost, ensure all data has been entered and submitted to the CRO/Sponsor. If not, the monitor has no data to review and a major purpose of the visit is defeated. The monitor will then have to sit and wait for data to be entered during the visit, which increases the amount of time on-site as well as the need for further visits.
2. Review Action Items from the Last Clinical Monitoring Visit
Take a look at the last monitoring follow-up letter. Are there still open action items? Try to have all outstanding items addressed by the next monitoring visit. If this isn’t possible, at least being aware of the issues and the steps being taken to remedy them in order to show the item is being addressed.
3. Review the Regulatory Binder
Perform a quick sweep of the regulatory binder. Has the latest correspondence been filed? Is Dr. Smith’s updated license present? Spending a little time reviewing the binder before the visit will result in decreased time and queries while the monitor reviews it during the visit. Reviewing regulatory items prior to the visit can also result in less follow-up items as missing/expired articles can be corrected beforehand.
4. Invite the PI to the Monitoring Visit
When possible, schedule an appointment to have the principal investigator (PI) meet with the monitor during the clinical monitoring visit. It tends to work out better than waiting to grab them as they run between the OR, clinic, and rounds. Additionally, any questions brought up by the monitor can be addressed during the visit, again leading to less follow-up items.
5. Check Meeting Times and Locations
Have meeting times and locations been coordinated with the monitor? A quick introduction email to the monitor prior to the visit that includes any directions or need-to-know information is always greatly appreciated. Making sure the monitor knows where they are going reduces the amount of “waiting around” time. Monitors are a flexible bunch, but letting them know any site specifics beforehand (such as only working until 3pm, or that medical records are stored at another location) ensures they can adjust their schedule to get the maximum amount done during the visit.
Sponsors: Partner With The Right Clinical Monitoring CRO
While we always recommend taking time to prepare for clinical monitoring visits, working with a quality monitoring group is equally important. Unfortunately, there are no formal training requirements for monitors, and turnover is often high. Hiring a monitoring CRO can offer many advantages, including objective oversight, a consistent approach and specific expertise.
Understanding how the monitoring CRO partners with sites is a critical piece to determining whether they will be a good extension of your team.
As a global medical device CRO, we take pride in the fact that not a single one of our sites has received a warning letter in our over 20-year history.
Our monitors bring a wide range of expertise and receive extensive training in clinical research regulations as well as our proprietary FAIR Shake™ technique, which helps them address issues where the answers aren’t always obvious.
To learn more about our monitoring services and what it’s like to work with us, request a free consultation today.