Jennifer Yee, Clinical Data Manager III & Amarachi Umez-Eronini, MPH, Biostatistician I / Statistical Programmer III, PROMETRIKA, LLC
The Data Standards Series: Part 3
As a digital repository for data collection instruments in a Clinical Data Management System (CDMS), a global library (GL) is used to streamline the database build process by increasing quality, time savings, and cost efficiencies. Although it’s a tool primarily used by Data Management and Database Programming, the GL benefits extend to multiple functional groups within a Clinical Research Organization (CRO).
At PROMETRIKA, some of the groups impacted by the availability of a GL are:
- Data Management and Database Programming
- Clinical Operations
- Project Management
Each of these areas gains unique advantages from the use of our global library.
Data Management and Database Programming
During study start-up, use of a GL can greatly reduce the time and effort invested in a database build. Since the GL is a pre-validated instrument, its components, such as a Case Report Form (CRF), can be pulled from the GL without reprogramming or retesting. Typically, the CRF development process requires creation of a specification, cross-functional review, programming, and user acceptance testing (UAT). By ensuring that GL elements remain unaltered during database build, these time-consuming steps required by Data Management and Database Programming can be eliminated from the database build process.
If sponsors wish to enjoy the time and cost efficiencies associated with the library, they should avoid deviating from the pre-validated GL design. When changes from the GL design are made, Data Management and Database Programming are required to execute the normal testing procedures, negating the potential savings associated with copying. This reality provides Data Management with leverage when it comes to database design. By encouraging sponsors to retain the GL setup, Data Management reduces the non-essential or “nice-to have” design requests that can hold up the process and add unnecessary complexity to the build.
Another benefit of the GL is that it enables better communication between Data Management and Database Programming. The GL standards help each group know what to expect from the other—efficiencies and time and cost savings are achieved when Data Management is designing certain specifications for the database setup and Database Programming is familiar with the design preferences established by the GL.
Finally, a GL helps the Database Programmer be more efficient when it comes to executing build activities. With the library in place, the programmer can simply pull objects into the new study and not have to create them from scratch each time.
For the Biostatistics group, using a GL increases efficiency, reduces human error, decreases the amount of rework required, and ultimately produces cost savings. At a CRO studies can vary by design and content across sponsors and studies, but the statistical analyses performed and reported are often similar. Having a GL increases data traceability and data consistency from CRF data collection to Study Data Tabulation Model (SDTM) datasets. In turn, this streamlines the creation of standardized deliverables such as Statistical Analysis Plans (SAPs), Analysis Data Model (ADaM) dataset specifications, Table, Listing, and Figure (TLF) Shells, TLF programs, and the corresponding outputs. To make deliverable execution more efficient, the Biostatistics group contributes to the CRF design at earlier stages of development ensuring that study data can be integrated in a manner that captures study objectives and endpoints needed for data analysis and clinical trial reporting.
The combined use of a standardized CRF and GL, with early involvement of Biostatistics in a clinical trial, ensures that standard methods for collecting, analyzing and reporting trial results are implemented. Programmers gain experience with having similar and consistent data structures and pre-existing mappings for data conversion, reducing programming time needed for deriving study endpoints. During statistical review of datasets and outputs, Biostatisticians can focus more on internal consistency and validity of trial results knowing that important analysis considerations have been handled according to methods outlined in the SAP. Without standards, the methods and algorithms used to derive key study endpoints can vary from study to study. Such inconsistencies, make it difficult to catch data issues, logic flaws, and other random errors that can occur during programming. When standards are in place, the amount of data checking and data transformation work is significantly reduced.
In Clinical Operations, the GL allows for early input and ongoing feedback from the perspective of the site user—the clinical research coordinator (CRC) or the clinical research associate (CRA). Feedback from the site-perspective allows for alignment between the data collection workflow in a clinical setting and the electronic data capture (EDC) system. For instance, Clinical Operations can provide feedback for the naming conventions and display order of assessments as they are seen in the clinical setting. Streamlining CRF design between the clinical database and source documents can reduce site burden, reduce transcription errors, and ultimately increase accuracy during data entry. What’s more, it enhances the user experience, as consistent form design means users don’t need to re-familiarize themselves with a new setup or format for each clinical trial. Additionally, the familiarity and consistency in design reduces the overall training requirements for site personnel, which further contributes to the study’s efficiency and cost effectiveness.
Pharmacovigilance is always an essential component that is paramount to every clinical trial’s successful execution. One of the most powerful tools for ensuring safety in a clinical trial is a well-defined set of standards. The GL not only allows Pharmacovigilance to contribute their perspective and opinions on design, it ultimately allows them to establish data collection guidelines and regulatory standards, so they can be applied consistently across various trials and different safety databases. Standardization also promotes data integration with other data repositories and real-time safety surveillance.
Although they do not directly work with the clinical study data, the PROMETRIKA Project Management group is also aided by the implementation of a GL. With continued implementation, data standardization afforded by the GL creates downstream consistency in project execution. In turn, this provides Project Management with more clarity when producing budgeting metrics. It also facilitates more accurate and predictable timeline forecasting with reduced design variability, customization, and rework during database build and analysis. Finally, metrics associated with GL use allows for systematic quantification of efficiency discounts that sponsors request when looking to partner with CROs.
Maximizing the Impact of the Global Library at PROMETRIKA
As a CRO, PROMETRIKA works with a variety of sponsors, each with individual expectations and requirements when evaluating vendor partnerships. Although each is unique, all sponsors expect their preferred vendors to execute projects with both quality and efficiency amidst aggressive timelines.
As a boutique CRO, PROMETRIKA’s expertise lies within the rare disease space; a distinct niche that requires special attention and flexibility stemming from smaller populations, design heterogeneity, and an evolving understanding the disease’s natural history. The GL is one means by which PROMETRIKA can deliver quality and efficiency within the constraints of aggressive timelines, but also amidst the fluid nature of trials with rare disease indications. Developed as a cross-functional effort within our organization, the GL focuses on the essential elements required for every clinical trial and represents PROMETRIKA’s united front when it comes to standard design and implementation. With an established GL, PROMETRIKA’s team members utilize library standards so that their focus and expertise can be allocated to indication-specific elements; essential in the rare disease space.
The global library is a tool that offers a wide variety of benefits to CROs and the sponsors with whom they collaborate. At PROMETRIKA, we capitalize on every one of those benefits, enabling us to produce the highest quality results quickly, efficiently and safely. Utilizing a GL is advantageous to our company, our sponsors and ultimately the people impacted by the drugs we help bring to market.
This concludes the final installment of the three-part Data Standards series. Want to revisit the first two? Click Below!