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Webinar Q&A Follow Up: How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality

On September 18, I presented a webinar entitled "How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality," during which I discussed the importance of database (DB) lock as a trial milestone. A key step towards DB lock is tracking all activities are completed and clean for each patient (coding, external data reconciliation, query status, etc.), which can often be a challenge particularly for studies with large amounts of data.

I touched on how to apply insights to focus data cleaning efforts, methods of tracking the activities needed to achieve DB lock, early warning systems that help you avoid delays and methods of ensuring that no data have changed since the last clean. These strategies are integrated into Bioclinica's integrated tools that provide a programmatic approach to tracking study status: Clean Patient Tracker (CPT) (data aggregation from many study sources into one comprehensive source) and Clean Patient Optics (CPOptics) (web-based visualization of the clean patient status, based on the aggregated data in the CPT).

The webinar generated quite a few questions from the audience, so I thought I'd provide my answers again here in case you weren't able to catch them during the webinar.

  1. With the focus on less source data verification (SDV) as the data cleaning method, how will CPOptics change to keep pace with the idea that, in some trials, only 20% of SDV is enough?

    Since one of the ingredients is SDV status, it is easy to include a report showing which of the forms required for SDV have not yet had SDV performed. Then, in Express, this can be adjusted throughout the study.

  1. How do you reconcile external data?

    At Bioclinica, we follow a standard external data reconciliation process that allows us to have reconciliation workbooks quickly after we receive the first transfer from a vendor. Then, during their review, the Data Manager uses specific acronyms that essentially show whether an issue is resolved. If any issue for an external vendor is not resolved, it appears in the CPT as "No" for that vendor and, in turn, as "False" when loaded to the CPOptics, meaning the activity is not complete. When we receive a new vendor transfer and rerun the reconciliation, we use an Excel macro to copy the comments from our previous review so that we don't have to re-review any of the previous output.

  1. Does this mean that the study status shown is based on last data uploaded and not close to real-time status? For example, if it is uploaded once a day, it is only accurate as of one day?

    This is true. It is based on the last time the CPT was uploaded to CPOptics. For most studies that I've worked with, the vendor data are only received once per month. You could refresh the data in your CPT Input folder and upload it to the CPOptics more frequently, if desired.

    However, the data obviously will not reflect any updated external data reconciliation status.

  1. Can CPOptics be used during a study? Can it be used before study lock?

    Personally, I think it is best to use CPOptics from the start because you may be able to identify and address the bottlenecks or problem areas earlier, thereby eliminating the issue and resulting in a smoother trial overall. But, if you wanted to, you could start using it later in the study.

  1. Which data format is needed for Bioclinica's system?

    The CPT is loaded in .csv format, which is super easy to load. The Data Manager assigned to the study currently performs this step. CPTs can also be removed as the study progresses, so you can see the graphs quarterly, every 6 months or even yearly for those long trials. The tool is flexible in terms of how the output is displayed.

  1. Could this tool be used for centralized monitoring?

    I think it's a great tool for a Central Monitor to visualize the data status. And, since the Central Monitor is usually in close contact with the sites, he/she can prompt the sites to complete the needed activities for a clean patient group (CPG) or other activities that are lagging behind schedule. However, we also have a tool, ClearSite, that records the audit trail of the Central Monitor's activities, which is a requirement per the most recent regulations.

  1. Is this tool available to end users to run on their own?

    Yes, end users are the users viewing the application output. The Data Manager loads the CPT, but the end user can log in at any time to perform any filtering and any visualization that is needed.

  1. How long does it take to set up study-specific parameters or ingredients?

    Not long at all! At the start of the study, a template is completed that includes all the possible external data, and you choose whether you need to use all of it. The real work happens when you're viewing the data in the reconciliation workbook or the manual listings to determine if the issues are really problems or can be used as is.

  1. How are CPGs established?

    I recommend that the data management team assign the CPG numbers. The team understands the data and is performing the analyses. It's not an exact science, but the team chooses the patients that have already completed the trial and are closest to being clean – in other words, those that have the least complicated task to perform to become clean (e.g., closing a query or performing an SDV). The number of patients within a CPG varies between studies, although once established for a study, the CPG number assigned to patients should be maintained; that is, once a patient is assigned to a CPG, they are not reassigned to another CPG. One factor that helps determine the right number of patients in any CPG is the workload of the medical monitor.

  1. Can CPOptics be used with non-Bioclinica systems?

    We are currently offering use of the tools for studies using Express and Bioclinica data management services, but the tool itself is system agnostic. The ingredients are key, but so is the tool to load those ingredients into the .csv file (in this case, the CPT), which must currently meet the template requirements. Essentially, information can be gathered from any platform. At some point in the future, for studies performing their own data management, if the .csv file was provided in the appropriate format, they could use the CPOptics tool.

Want to learn more about Bioclinica's Clean Patient Optics? Contact me at karen.mcpoyle@bioclinica.com.

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