SCOPE 365 is partnering with TransCelerate Biopharma to crowdsource innovative solutions from across the clinical research ecosystem. Each Challenge highlights a real-world problem identified by industry leaders and invites participants to develop and showcase practical solutions. The program provides visibility for cutting-edge approaches, engages diverse stakeholders, and fosters collaboration among sponsors, CROs, technology providers, and other innovators.

Challenge Title: Automating the Configuration of Data Acquisition

Problem: Multiple clinical data acquisition applications need to be configured or set up for study execution based on the data collection requirements specified in the clinical study protocol. Today this configuration process is typically done manually and is repeated for multiple applications per study. Data Managers or Clinical Database Programmers read the study protocol document and then interpret and re-enter information do configure each data acquisition application. The process repeats again to conduct protocol amendment impact analysis and re-configuration when needed.

Solution: A digital protocol in the USDM standard format can be used to automate many parts of the configuration of data acquisition applications. This approach can reduce study setup cycle times and improve the quality elimination errors in the data acquisition application setup due to manual translations.

Challenge: Demonstrate how the configuration of clinical data acquisition applications can be improved using a USDM digital protocol to automate parts of the process eliminating manual steps, reducing setup time and effort, and improving quality. All systems that collect clinical study data are in scope improved review capabilities that can be realized utilizing a USDM digital protocol providing certain stakeholder groups with a dynamic and digital protocol review solution. Submissions should clearly describe the potential value in real settings, backed up with benchmarks and metrics.

Solutions may include, but are not limited to:

• The autoconfiguration of one or more applications that collect clinical trial data e.g. eCOA, ePRO, IRT/IWRS/IVRS/Randomization, LIMS, eSource, EHR, Imaging Systems, various digital health technologies, etc.
• For data types (e.g. central lab data) that are typically transferred to sponsors via file transfer or system-to-system connections challenge submissions can include the automation of data transfer specifications and/or the configuration of the file transfer process.
• Connections to additional metadata sources to achieve higher degrees of automation. For example, functionality that matches required protocol assessments and data to a standard forms library maintained by a sponsor.
• Features such as leveraging AI models and USDM input to auto-generate eCRF forms.
• Functionality to maintain and visualize the lineage between the requirements in a version of the protocol and forms, objects and fields in the data acquisition application.
• Procedures for quality control checking to confirm the correct configuration of data collection applications such as review of data required by timepoints and generation of test data and automated testing scenarios.
• Amendment impact analysis detailing the impact of a given amendment on the configuration of data acquisition applications

Supporting Materials: Sample protocols in PDF and USDM format are available here.

Challenge Judges:

- Wafaa Jebert (Merck)
- Samit Jana (Eli Lilly)
- Camilla Kehler (Novo Nordisk)
- Chris Decker (CDISC)

How to Participate

1. Submit an Abstract

• Provide a clear summary of what your solution.
• Any/all identifying company information in the abstract will be blinded before presentation to the judging panel.

2. Finalist Invitation

• Selected abstracts will advance to the finalist round.
• Finalists will be asked to prepare a short video (up to 5 minutes) demonstrating their solution in action.

3. Judging & Recognition

• A panel of judges assembled by TransCelerate will review blinded submissions.
• Finalists and winners will be announced at SCOPE Europe and highlighted across SCOPE 365 channels.
• Winning entries will be recognized at the SCOPE Europe plenary session, with opportunities for further visibility.

The deadline for submission is: August 18