In all clinical trials, one of my ultimate goals is to obtain accurate, clean data as quickly and efficiently as possible – all while minimizing overall trial costs. Although the trial data results are the end goal, I never want to sacrifice subject safety to get it.
Subject safety is the reason we follow the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP). Institutional Review Boards (IRBs) are in place as a means of ensuring we follow ICH/GCP throughout the life of a clinical trial.
To remove bias, third-party vendors monitor and verify clinical trial data. It is this vendor, often a Clinical Research Organization (CRO), that is responsible for sending out Site Managers (SMs) to perform monitoring visits at all sites chosen to participate in the trial. During these visits, SMs review source data for accuracy and completeness.
SMs ensure that site staff have been compliant with the protocol, verify Principal Investigator trial oversight, perform drug accountability, verify documented site training and can work with the site staff to reconcile any discrepancies noted. At the completion of a visit, the SM leaves the site as ‘audit-ready’ as possible.
As SMs have many responsibilities, it is easy to see that there are many ways in which trial data delays can occur. As a former Lead SM and now a Clinical Operations Lead, I have learned that one of the most basic ways to lose time in a clinical trial is by having the monitoring visits occur out of the scheduling window.
What is the Problem?
We can only rely on clinical trial data entered after a SM has verified it. Therefore, it is crucial to have monitoring visits occur according to the timing schedule found in the Clinical Monitoring Plan (CMP) / Clinical Operations Plan (COP). When these visits do not occur within the scheduling window of the CMP/COP, it leads to untimely source document verification (SDV).
Untimely monitoring visits can create a multitude of problems during clinical trials. In my experience, a delay in SDV has a negative chain effect. Other clinical departments (i.e. Safety, etc.) are unable to perform their review until after the SM has performed SDV.
This prolongs the time it takes for overall trial data reconciliation. The Data Management department may also spend an endless amount of time querying unverified/unclean data unnecessarily. This is not just a poor use of time but can be a very costly endeavor for pharmaceutical/sponsor companies.
During the SDV process, SMs often find unreported Adverse Events (AEs) and/or Serious Adverse Events (SAEs). SAEs require reporting to the sponsor company and the IRB within specific timeframes. As mentioned earlier, subject safety is my highest priority during any clinical trial.
Therefore, prompt assessment and documentation of AEs and SAEs is a must. If monitoring visits are not occurring according to the CMP/COP, I cannot ensure this. Any delay in SDV can also lead to protocol deviations going unnoticed and possibly repeated for subsequent subjects at multiple subject visits.
What is the Remedy?
In our very technologically savvy world, there is any number of calendar date generating applications and websites one can choose. I have used the following website when I do not want to be relegated to the use of a ‘date wheel’: https://timeanddate.com.
There is even an associated phone application for iOS called ‘Time & Date Calculator’. Both the website and phone app require me to enter the date of the initial visit and then the number of weeks/days/months required in the interval.
Once I enter that information it will calculate when the next visit should occur. If I need to create something more tangible for my SM team, I input a trial-specific formula into an Excel spreadsheet.
This enables anyone on the clinical study team to generate the same information as the above-mentioned website, which is helpful when SMs need to forecast future monitoring visits.
Whichever method is chosen, I know that I am creating a check and balance system that can minimize the timing of trial data available for further analyses. CROs can use these measures to ensure that their employees are following the CMP/COP and to hold trial sites to their contractually agreed upon availability.
Likewise, pharmaceutical/sponsor companies can use these methods to verify that a CRO is adhering to their contractual obligations for overall trial monitoring. Most importantly, though, by finding a method that works best – it will aid in getting clean trial data submitted in a timely fashion.
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