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In this article, Moe Alsumidaie will discuss how my study teams manage monitoring reports and offer a tracking tool to assist sites with the process.
Monitoring visits are daunting not only for monitors but also for study sites. When monitors review data for a new study at a site they have recently become acquainted with, they spend a significant amount of effort investigating common study-related issues, how the site operates and uncovering many findings regarding data quality and site operations. Initially, monitoring reports tend to be very long, issuing numerous actions to sites for resolution. Unfortunately, study sites that are juggling between several studies sometimes find it challenging to keep track of monitoring actions and resolving them. In this article, I will discuss how my study teams manage monitoring reports and offer a tracking tool to assist sites with the process.
Conduct Internal QCs Before Monitoring Visits
As a research coordinator, it is essential to ensure that the quality of your documentation sufficiently meets gold standard quality, which is based on ICH recommendations, FDA regulations, and ALCOA methodology (Attributable, Legible, Contemporaneous, Original, and Accurate). It is recommended you conduct a quality control (QC) review of all source documentation before the monitoring visit occurs. Specifically, all study-related source forms need to be adequately completed (i.e., signatures are in appropriate places, any missing fields are filled out), patient source documents are available to support source form data and demonstrating documentation on subject eligibility.
Even after you conduct a QC, you should expect the monitor to find deviations and assign actions, not because of site-related issues, but also because the entire study team (including the monitor and sponsor) is learning about common study-specific mistakes that sites make, as well as unforeseen problems that the sponsor study team becomes aware of due to protocol design flaws.
Track Monitoring Actions
Receiving a monitoring visit report is no fun, especially when you receive a slew of action items. Nonetheless, you can quickly address these items by organizing them in a tracker. Specifically, the tracker below should help you organize and resolve your monitoring visit findings.
Table 1: Monitoring Visit Issues Tracker Categories
Naturally, you would have to track every event by subject ID and list the monitoring visit observation. You also have to document whether or not the action is a protocol deviation and if so, whether the deviation is major or minor. It is also important to check with your monitor whether the deviation needs to be submitted to the IRB for review. Once you determine these items, you have to take action and document what action you took to resolve the monitoring visit finding. It is also essential to evaluate whether the monitoring visit issue is a one-time event or a recurring event which is a part of a bigger problem. Accordingly, you must document a risk mitigation strategy to avoid repeating the same mistake, as auditors will look to see if your site is repeating the same mistakes and will penalize you for not taking appropriate action. Once you resolve the issue, it is vital to document resolution date, as well as IRB submission dates.
Note to File Generation
Some actions, such as completing missing information on source forms, or resolving adverse events can be documented on your tracker. However, other items such as protocol deviations, need further documentation to confirm review and oversight by the PI. This is where notes to file (NTF) play a role. NTFs need to (a) describe the purpose of the issue, (b) represent the problem in more detail and whether the problem impacted the patient’s safety and/or well-being, (c) what site staff did to resolve the issue, and (d) what process will be put in place to prevent issue recurrence. The note to file will have to be signed by the PI, dated, and delineates the site number, sponsor, and study title. Once the NTF is complete, you will need to file it in the respective patient folder/binder.
Maintain NTF and Protocol Deviation Logs in Regulatory Binder
Having NTFs and protocol deviations from previous monitoring reports floating around creates disarray if your monitor changes, or if an auditor conducts an audit. Similar to an adverse event log, creating an NTF and protocol deviation log helps to organize and rapidly access documentation.
The log also offers a snapshot of what happened in the study, and subsequent actions are taken; this helps you better understand your site’s performance improvement on particular issue areas, and whether your risk mitigation strategy is working at preventing those issues from recurring.
Proper Organization and Documentation Will Save Your Site
Creating monitoring visit issues trackers and documenting resolution not only creates a practice that supports ALCOA methodology, but, also improves the relationship between your monitor and your site, shortens monitoring visits, results in less monitoring findings during visits, lessens protocol deviations, and reduces the chances of significant findings during audits.
Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.