Jennifer Yee, Clinical Data Manager III, PROMETRIKA, LLC
The Data Standards Series: Part 1
The top priority of a Clinical Research Organization (CRO) is to help a sponsor conduct a successful clinical trial. That success is measured in data quality, process efficiency, and cost effectiveness. In order to achieve these goals, many organizations find they benefit from the development of a global library. A global library (GL) is a digital repository in a Clinical Data Management System (CDMS) that contains data collection instruments, such as electronic case report forms (eCRF) and their associated programming elements.
During database build, the library functionality allows for the copying of pre-validated objects, such as variables, code lists and edit checks, from the GL into new projects. Confidence in the pre-validation of the GL allows these objects to be copied without reprogramming or testing. By eliminating these time-consuming tasks, CROs can develop projects with design consistency, significant time savings, and reduced cost; features critical to the success of a study.
Global Library and Data Standards
In addition to being a time and cost saving tool, a GL is also a vehicle by which CROs can implement data standards across a project. In the clinical research industry, the Clinical Data Interchange Standards Consortium (CDISC) is a nonprofit organization that develops data standards, such as CDASH, SDTM, and ADaM to help streamline and improve the execution of clinical trials.
CDISC data standards establish the framework for organizing and collecting study data by providing dataset templates, standard data collection conventions, and guidance for transforming raw data during analysis. In turn, this uniformity created by the standards promotes data sharing and allows the FDA and other regulatory bodies to efficiently review the study data.
To maximize the benefits from CDISC’s data standards, CROs can build them directly into the GL. This allows for the standards and their associated efficiencies to be carried throughout a study’s lifecycle, from study start-up, through study conduct, and finally into analysis and reporting.
Key Benefits of Using a Global Library for CROs
In addition to improvements in data standards and time and cost efficiencies, implementing a GL at a CRO has a clear and positive impact on many aspects of clinical trial management, including:
- Improved communication. The standardization of forms and other materials across studies provides a more consistent experience for end users. As a result, less training is required when the sites and the clinical research associates (CRA) are already familiar with the data collection tools. Having a proven set of components based on industry standards also simplifies decision making with the sponsor regarding study design.
- Enhanced data quality. The time invested in building and organizing the most effective design elements into a GL eliminates redundancies and improves the quality of collected data. It also minimizes the amount of data transformation required when information is sent for analysis. What’s more, using a GL facilitates data sharing and integration between computer systems within a single project and between multiple projects within an organization.
Ultimately, having a GL is very important to any CRO, and by extension, to the sponsors with whom they collaborate.
PROMETRIKA’s Use of a Global Library
In our work, we are seeing a steady increase in sponsors seeking partnerships where there is an opportunity to participate in multiple projects, each with an aggressive database build timeline. Sponsors also have ever-higher standards for achieving the kind of project consistency that delivers the highest quality data.
In both cases, we have found that having a well-defined and easily accessible GL is crucial to our success and to supporting positive partnerships with our sponsors. Using a GL also allows us to keep our collaborative approach front and center. It creates a unified perspective on a trial across all our functional groups, giving team members in all areas the ability to contribute at the early development stages of a study. For instance, the GL allows data management to establish design consistency, biostatistics to define variable attributes that reduce rework, and clinical operations to align workflow between the clinical setting and electronic data capture. In addition, it can be especially helpful in supporting our work on rare disease clinical trials, where automation of standards and low-value tasks facilitates resource allocation to our areas of expertise in indication-specific design.
The Data Standards Series continues! Stay tuned next month for an in-depth look at the CDISC data standards we use in our global library. We’ll explore both CDASH and SDTM: what are the differences, benefits of implementation, and why do you need both?