The Schedule of Assessments (SoA) in clinical research protocols serves as one of the most important roadmaps clinicians, researchers, sponsors, and monitors use to guide the trial from start to finish. This roadmap, also sometimes referred to as the Schedule of Activities or the Schedule of Events, outlines study visits and scheduled activities expected for each visit throughout the study with detailed timelines to follow. This provides the visualization of milestones to expect during the trial and is critical to the successful execution of each study visit. A SoA is used by data management to understand each data capture element defined in the protocol that is needed for the study. Protocols are continually becoming more complex year by year but suffer with pressure to reduce study timelines. According to Tufts Center for the Study of Drug Development, a late-stage clinical trial averages around 3.6 million datapoints derived and collected from the protocol and protocols average around 3.5 amendments^1,2. This data alone induces the need for creating a digital, source of truth SoA. In this growing digital world, clinical trials must continually make advancements to streamline processes and improve upon efficiency and accuracy. Digitizing the SoA is a progression that can enable a consistent dataflow, shortened timelines, and enhanced protocol adherence.

Typically, you can find the SoA located on a few pages in a clinical trial protocol created on a word document. It appears in a table that creates a chronological visit outline and specific checklist of each assessment expected at that visit. Further detailed information about each visit and assessment not included in the table is often found in embedded in the protocol in numerous different sections, in lengthy footnotes or appendices. In a digital SoA, every assessment or measurement is defined alongside industry standards with inclusion of what would be written in these footnotes or other sections of the protocol. Creating a digital SoA, combines this information into a searchable format and eliminates manual review across different sections of the protocol, reducing the risk for missed required datapoints. Every assessment or measurement used in protocol design that was created in the digital SoA platform, would be defined universally enhancing the understanding of what is to be expected out of that requirement and laying the foundation for a Digital Protocol.

Furthermore, sponsors and study teams, even within an organization, often  refer to the same specific assessment by different names. Within a digital SoA, a standardized language is employed allowing for easier communication and shared understanding across key stakeholders, improved interoperability with downstream consumers of the SoA content, and streamlined updates for protocol amendments. For example, the digital SoA can quickly be updated from standardized information as amendments are approved, minimizing the room for error, protocol deviations, and missed system updates. Research staff and Clinical operations teams can refer to a single source of truth that holds all relevant information and rely on its accuracy to guide their practices.

This standardization also drives enhanced data management, one of the most prominent areas in clinical trials that can benefit from a digital SoA. Traditionally, electronic data capture (EDC) systems are created by a Data Manager that reviews the SoA document and translates it into defined system requirements and specific data standards³. This digitized information removes the need for translation and sets the stage for automation to associate the assessments listed in the SoA with the comparable data standards, system requirements and data collection forms³. EDC can be developed in direct accordance with the protocol requirements within every patient visit. Navigation within those EDC platforms would directly correlate with the protocol, in a user-friendly platform. Digital SoA takes a traditionally time consuming, tedious process and streamlines it to benefit data collection across the trial. Further, a digital SoA promotes a data driven design by its ability to provide real-time insights on decisions made by Data Managers or research staff. For example, a digital SoA can provide a snapshot of a what data would be impacted if a lab assessment is missed. Data snapshot abilities can reduce the burden on a Data Manager, allowing users togenerate queries showing the impact of different decisions and scenarios prior to them occurring. A study team can guide their decisions for each patient based upon real-time, real-world data and see the risks, safety information, patient overviews, data impacts, etc. that each decision may cause.

Additionally, data management teams need consistency. The information found within a digital SoA is reusable for future protocols and creates standardized repeatable workflows such as downstream integrations and document generation⁴. Interoperability is improved through standardization using a consistent data model such as USDM (Unified Study Definition Model) supported by industry standards (e.g., ICH M11: Clinical electronic Structured Harmonized Protocol (CeSHarP)⁵ , CDISC controlled terminology⁶, etc.)As each assessment and measurement is defined, this consistency in data model and terminology allows information to more easily flow downstream across platforms and documents like EDC, CTMS, IRT, lab manuals, etc. bridging the gap between systems and reducing manual effort for the study. All in all, a digital SoA supports the data management process, while maintaining improved efficiency and accuracy in trials.

The concept of turning a clinical trial “digital” is no stranger to researchers. Technology has continually changed the face of clinical trials and overcome challenges through its developments. The benefits that are seen can be endless – processes have been streamlined, costs are reduced, patient data is better obtained and protected, accuracy and ability to adhere to protocols are improved, etc. Implementing a digital SoA is just one of those impressive developments. The SoA carries the weight of success for researchers, therefore, its development into something more is important to consider as the field continues to further digitize and embrace technology.

References

1. Tufts Center for the Study of Drug Development. Impact Reports – Rising Protocol Design Complexity is Driving Rapid Growth in Clinical Trial Data. csddtuftsedu. 2021;23(1). https://csdd.tufts.edu/impact-reports.
2. Ken Getz, M.B.A. K. Shining a Light on the Inefficiencies in Amendment Implementation. wwwappliedclinicaltrialsonlinecom. 2023;32(12). https://www.appliedclinicaltrialsonline.com/view/shining-a-light-on-the-inefficiencies-in-amendment-implementation
3. Georgieff T. Navigating toward a Digital Clinical Trial Protocol. wwwappliedclinicaltrialsonlinecom. 2023;32(12). Accessed May 3, 2024. https://www.appliedclinicaltrialsonline.com/view/navigating-toward-a-digital-clinical-trial-protocol
4. XTalks – Faro Health Inc. Clinical Data Management Insights: Using Digital SoA to Solve Modern Clinical Trial Challenges. Xtalks. Published August 24, 2023. Accessed May 7, 2024. https://xtalks.com/webinars/clinical-data-management-insights-using-digital-soa-to-solve-modern-clinical-trial-challenges/.
5. International Council for Harmonisation of Technical Requirements. ICH M11: Clinical Electronic Structured Harmonised Protocol (CeSHarP) FDA and Health Canada Regional ICH Consultation.; 2023. Accessed May 7, 2024. https://www.fda.gov/media/167334/download.
6. CDISC Digital Data Flow for Clinical Trial Protocols. Accessed June 21, 2024 https://www.cdisc.org/ddf

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