6.1 Digital retrospective
Goal: Organizational learning and regulatory compliance
The trial is complete, but the opportunity for learning has just begun. This is the time to securely freeze your data and transform the outcomes—both positive and negative—into precise, actionable organizational intelligence.
The retrospective is your essential “what went well, where can we improve” exercise. It focuses on capturing successes, identifying opportunities for enhancement, and, when necessary (such as in cases of clear issues or failures), delving into root cause analysis. This process ensures audit readiness by verifying data integrity while providing evidence-based recommendations for future product refinement and trial operations.
Overview
Why this is your most important review
This is the essential final review to capture organizational wisdom, effectively converting trial experience into a proven, repeatable strategy that permanently reduces risk and accelerates your next digital deployment. By documenting what worked effectively and where adjustments could yield even better results, you build a foundation for continuous improvement that benefits everyone involved.
For adopters: You establish the definitive, auditable record of the trial for regulatory and quality assurance purposes. You gain clear, documented operational lessons to inform the next protocol (e.g., precise changes to site training or adherence monitoring plans).
For developers: This is a vital moment for product enhancement. You receive detailed, trial-specific feedback to enhance reliability and user satisfaction. Use insights to enhance product robustness and market readiness.
in practice
Step-by-step actions: Securing the audit record and lessons learned
1. Finalize the record
You must freeze your sample-level and processed sDHT data to ensure immutability and traceability. This preserves data integrity for regulatory review and ensures a reliable dataset for future exploratory analysis. Protect the final data archive using secure, read-only storage and data integrity checks (for example, encrypted records with hash-based verification to confirm the data has not changed).
Adopters: Map the final data archive to your organization’s required analysis (e.g., CDISC SDTM/ADaM) and archival format. The clinical investigator must maintain and retain these source data as part of the adequate and accurate case histories.
Developers: Finalize the Software Bill of Materials (SBOM) and version provenance logs. This ensures compliance and provides the definitive change log for any future iterations.
2. Conduct the retrospective debrief
Convene a cross-functional debrief including developers, adopters, and site representatives to celebrate successes and explore areas for improvement. Focus on a balanced review that highlights effective strategies as much as potential refinements.
Celebrate wins:
Document what contributed to positive outcomes, such as seamless integrations, high adherence rates, or innovative workflows that exceeded expectations.
Identify opportunities:
Discuss any challenges encountered, classifying them broadly (e.g., technical, operational, or protocol-related). Where appropriate, apply root cause analysis to deeper issues, such as those that resulted in significant data loss or non-adherence.
Foster collaboration:
Encourage open dialogue to uncover insights that might not be evident from data alone, ensuring the process feels constructive and forward-looking.
3. Translate findings into actionable improvements
Retrospective insights can inform the planning for the next development cycle, turning lessons learned into codified best practices that drive efficiency and innovation. These translated findings and actionable improvements culminate in the creation of a comprehensive retrospective report, ensuring that insights are preserved and readily applicable for future endeavors.
Adopters: Document specific operational lessons learned (e.g., effective strategies for patient engagement that boosted retention, or minor workflow tweaks to reduce burden). This directly informs future protocol design decisions, aiming for leaner sample sizes and more efficient site workflows in future trials.
Developers: Document opportunities to enhance product robustness, such as refining sensor calibration or streamlining the application’s user interface (UI) based on real-world usage patterns.
FDA spotlight
“The FDA considers data captured from the DHT (including associated metadata) as source data. It must be securely transferred to and retained in a durable electronic data repository. The clinical investigator is responsible for maintaining and retaining this data.”
– Section IV.G (Record Protection and Retention), p. 21
Key deliverable
Generating your retrospective report
Your retrospective report creates a scalable blueprint for your sDHT strategy by documenting successes, improvements, and clear ownership of next steps. Beyond a simple summary, this document serves as auditable proof of quality assurance—maintaining positive momentum while enabling necessary course corrections.
Consider including:
Documentation of data integrity and audit readiness
Key successes and wins
Identified opportunities for improvement
Clearly defined, actionable next steps
6.1 Digital retrospective
Library resources to guide you
The sDHT roadmap library gathers 200+ external resources to support the adoption of sensor-based digital health technologies. To help you apply the concepts in this section, we’ve curated specific spotlights that provide direct access to critical guidance and real-world examples, helping you move from strategy to implementation.
Features essential guidance, publications, and communications from regulatory bodies relevant to this section. Use these resources to inform your regulatory strategy and ensure compliance.
Gathers real-world examples, case studies, best practices, and lessons learned from peers and leaders in the field relevant to this section. Use these insights to accelerate your work and avoid common pitfalls.