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CDM Staffing Shortages: 5 Ways EDC Optimization Can Provide Relief

CDM Staffing Shortages: 5 Ways EDC Optimization Can Provide Relief

By: Niki Kutac

Two years into the onset of the pandemic, CROs and Sponsors are seeing staff shortages, most particularly in the space of Data Management. This situation has led us to investigate several trends in EDC underutilization in trial builds we see today. As these organizations look to fill vacant positions in the current job market, there are ways in which eClinical technology can be used optimally to reduce this burden without sacrificing on data cleaning and management. Some of the areas meriting the most focus are outlined below.


Complex Edit Checks: Edit checks are an essential way to improve data quality in the EDC, providing real-time responses early in the data entry process to identify and resolve outliers. Commonly we see study builds configured only with simple logic checks, with clients relying more heavily on manual review to identify any deviations from complex and protocol specific criteria. While this does save some time up-front in EDC build time, it adds significant labor hours to the data collection and cleaning process. Building this complexity into edit checks in the EDC identifies any outliers and immediately notifies sites, rather than requiring attention and manual query creation from a Data Manager or CRA.

Implementing edit checks in the EDC helps identify those outliers upon data entry and alert the sites automatically versus requiring manual creation of queries/alerts by a data manager or CRA. When determining the edit checks to implement in an EDC study, the study team must identify not only the standard checks, like future dates or required fields, but also Protocol specific checks to help lessen the manual review. 

This means going beyond standard edit checks, like future dates or required fields, and delving into protocol-specific edit checks that more completely capture the specific requirements of the study. These can be very simple, from date ranges between visits to very complex checks between different data points to identify eligibility or safety items.  An EDC technology should provide an easy way to implement and test complex edit checks that look across forms, visits and data points. Rather than limiting complex, protocol specific edit checks, CROs and sponsors should be reevaluating how they can take advantage of the technology. Automating these checks in a robust system like Datatrak EDC, rather than replacing them with manual review, is an early investment of time that can pay serious dividends further down the road.


Effective Data Cleaning Tools: When resources are scarce, supporting technology must enable Monitors and Data Managers to perform their roles in the most efficient way possible.  This begins with designing a casebook promotes data accuracy and reduces the overall data cleaning workload. Use of dynamic forms and questions that are context sensitive, for example, allows control over when and which data are presented to investigators to complete. Minimizing the chance of investigator error, overall will result in less strain placed on Data Management.

Insightful reporting features are critical to efficiently identifying where work needs to be done, and are one of the first touch points where a greater investment into casebook design will be clearly seen. Every signal to begin investigation of casebook data that is captured in edit checks can be easily identified in a single location in Datatrak’s Alerts manager. This enables users to track items of note at a glance with dashboard checklists. But for details that were not captured in casebook design, perhaps weight loss/gain needs to be tracked across visits, our flexible ad hoc reporting tools make the process of generating a report to notify appropriate users of such an event simple and pain free.

During data cleaning itself, optimal use of EDC becomes more about leveraging the technology to support the workflows of individuals in Data Management. Datatrak’s manager framework not only supplements that need for Insight described above, it also enables users to perform data cleaning at many different levels and in different ways. Batch operations like SDV or Data Review can be performed across whole subject casebooks, visits, forms or individual questions. Similarly, queries can be issued and managed inline on eCRFs, but they can also be tracked and addressed, in batch from their own respective manager.


Easy Updates to Existing EDC Studies (Mid-Study Changes):  Mid-study changes are changes that occur after a trial goes live, due to protocol amendments or design optimizations, and they require utilities to help incorporate those changes into the existing study. It is essential in today’s clinical trial world that the technology utilized for EDC, ePRO, eConsent, CTMS or RTSM provides the ability to make updates to the system without downtime or data migration. While adding complexity to casebook design is often seen as a cost to startup times, an EDC that is sufficiently Agile when it comes to mid-study change provides the best of both works.

Having a technology that allows updates to edit checks or the casebook after the application goes live, provides clients the assurance that they can safely optimize the system through the trial lifecycle.  The ability to easily make changes to the configuration and apply those changes to existing data, provides clients flexibility in the event they need the EDC to go live in a very short time.  With Datatrak, clients can deploy the system with simple edit checks, and design and test the complex checks as the study starts enrollment and apply those changes at a later date. 

Read more about our mid-study changes function here:


Shift to Real-Time Data Collection: With the rise of Decentralized Trials and the practice of collecting data directly from patients, the need to monitor that data decreases as do the associated labor hours. Provided all the supporting technology is 21 CFR Part 11, GDPR, and HIPAA compliant, a seamlessly integrated ePRO and EDC are able to substantially reduce the volume of data requiring SDV.

Utilizing the Datatrak Direct iOS or Android app, sites and patients can enter data directly into the system as it is collected from the patient. Information in the application is automatically sent to Datatrak’s EDC, and scrubbed of any PHI (protected health information). As this data is electronic source information, users can reduce or eliminate the usual practice of having a Coordinator re-enter the data into the EDC and the requirement for CRA’s to perform SDV afterward.


Easy to use technology:  When resources are scarce, it’s imperative to have technology in place that is user friendly and easy to learn when onboarding new hires.  As CROs and Sponsors fill their staffing needs, having an eClinical platform that provides electronic training and an intuitive interface will help ensure the resources start contributing as soon as possible. 

At Datatrak, our goal is to provide the most innovative eClinical solutions bundled with premier service offerings to optimize your clinical trials. Our system focuses on role-specific tools that are easy to learn by design. We have an extensive library of web-based eLearning modules that allow our customers to effectively scale their training efforts for new users. These modules can be accessed anywhere, at any time, providing a convenient and effective way for new staff to learn about our platform functionality at their own pace.

 Implementing comprehensive eClinical technologies now can help CROs and Sponsors optimize their operations and amplify the potential value of tools they already use. A system that can best capture, clean and report on data without demanding extra overhead in personnel resources is one that can help you overcome staff shortages now and further down the road.