Remote
Source Review​
Conduct Site Monitoring Visits from Anywhere
I led the design effort for Remote Source Review (RSR), a cloud-based application revolutionizing Source Data Verification (SDV) and Source Data Review (SDR) in clinical trials.
Throughout the design process, we placed a high emphasis on user-centricity, conducting extensive research and incorporating user feedback at every stage. Our goal was to create a user interface that simplifies the review and verification of clinical documents, enabling monitors to easily identify any discrepancies between physical documents and the captured data in the Electronic Data Capture system. By prioritizing user needs and employing a thoughtful design approach, I aimed to empower monitors and site staff with an intuitive tool that enhances their productivity and ensures the accuracy and integrity of clinical trial data.
Problem
Addressing the Challenges of Remote Site Monitoring
The existing source review solution fails to meet the increasing demand for remote site monitoring during clinical trials, exacerbated by the COVID-19 pandemic. Monitors lack the ability to specify required source documents, causing inefficiencies and reliance on external communication channels. Site users struggle with uploading and managing the large volume of documents needed for each remote monitoring visit. It is imperative for RSR to address these challenges and provide a comprehensive solution that caters to the needs of both monitors and site staff involved in remote source review and verification strategies for clinical trials.
Discovery Process
Discovery Plan
The discovery process for the RSR project began with a pre-kickoff meeting, where I collaborated with the Product lead to align on the project scope and timeline. Based on this, I formulated a comprehensive design strategy that spanned a six-week discovery phase. The key elements of this strategy included various activities aimed at gaining insights and understanding the user journey.
Framing The Project
To kick start the process, we conducted a Product Framing workshop, where we identified the known problems and opportunities that the redesign aimed to address. This workshop also allowed us to align project expectations, define individual responsibilities, and establish desired outcomes with our Product and Dev counterparts.
Maps & Journeys
Next, we conducted product demos and subject matter expert (SME) interviews to develop a user journey that captured the steps involved in completing Source Data Verification (SDV) and Source Data Review (SDR) tasks, independent of technology. This helped us gain a holistic understanding of the users' workflow, as well as align on all the business requirements.
Analysis & User Interviews
To gain further insights, we conducted competitive analysis and analog analysis. This allowed us to identify the value we wanted to bring to the market and leverage proven ideas from analogous solutions, reducing the time spent reinventing the wheel.
Another crucial step was conducting interviews and virtual shadowing sessions with monitors and site staff. These interactions provided valuable validation of our assumptions, filled gaps in our knowledge, and offered a detailed understanding of the day-to-day work processes of these users.
Product Vision
At the conclusion of the discovery phase, we presented our findings to the Product team. We shared our initial high-level ideas in the form of lo-fi designs, ensuring alignment on the design strategy moving forward.
Key Insights
Standardize Task Creation Workflow
Our discovery revealed that over 90% of trial protocols require verification of all source documents. To address this, we aimed to introduce a standardized task creation workflow in RSR.
Monitors will have the ability to specify the documents they don't need for specific visits, allowing for exceptions while ensuring that all required documents are verified. This will streamline the process and provide clarity to both monitors and site staff, reducing the need for external communication.
Intuitive Document Management for Site Staff
Our research highlighted that site staff often face challenges in managing their busy schedules and the time-consuming task of pulling and uploading documents for monitoring visits.
We set another goal for RSR, to provide an intuitive and efficient document management system. This system should allow site staff to easily upload and organize documents within the application, providing flexibility in completing their tasks. By streamlining the document management process, we can alleviate the burden on site staff and ensure smoother operations during remote source review.
Contextual Communication Capabilities
The discovery phase uncovered the inefficiencies caused by the lack of communication within the RSR system. Monitors and site staff often resort to external communication channels to address issues or clarify information related to documents uploaded in the application.
To overcome this challenge, RSR needs to incorporate effective communication features. This may include in-app messaging or commenting functionalities that allow users to communicate and collaborate directly within the system. By enabling seamless communication, we can reduce the reliance on external channels, minimize errors, and foster efficient collaboration between monitors and site staff.
Concept Development
During the concept development phase, we focused on aligning our goals of efficiency, trust in predictions, and task specialization with the insights gained from user research. Here are the key concepts we developed that would guide our product design solutions:
Auto-Generated Tasks based on Scheduled Visits
By leveraging the schedule of events data from the study design application, we can implement a feature that automatically generates tasks for monitors based on each scheduled monitoring site visit. This concept aligns with the goal of streamlining the task creation workflow and addressing the user need for efficient document request management. Monitors are freed from manually requesting documents, and only need to identify exceptions where specific documents are not required.
The auto-generated tasks also provide a comprehensive view of the verification status of every document in the study, ensuring transparency and clarity for all stakeholders involved.
Site Documents
To address the challenge of managing a large number of requested documents while juggling busy schedules, we could introduce the concept of Site Documents. This can provide a dedicated space within the application for site staff to upload and identify multiple documents at once, even using their mobile devices for convenience.
The Site Documents concept aligns with the goal of enhancing the document management system and addresses the user need for a streamlined and efficient way to handle document uploads and organization. Site staff can easily manage and access the requested documents, reducing the time and effort required for document handling.
Queries for In-App Communication
To eliminate the inefficiencies caused by external communication channels, we could implement a Queries feature, enabling monitors and site staff to communicate within the application. This concept directly addresses the need for seamless communication between monitors and site staff.
With Queries, all communications related to requested documents can be kept within the context of each monitoring site visit. This centralized communication approach enhances collaboration, reduces errors, and improves overall efficiency in the remote source review process.
User Testing & Feedback
We created a prototype that emphasized the high-value features aligned with our design goals. This prototype served as a representation of our solution and allowed us to gather user feedback through testing.
We then reached out to the same users we previously interviewed and invited them to participate in user testing sessions. These participants were given tasks to perform using the prototype. We observed their interactions, noting their actions, behaviors, and feedback. This allowed us to understand how users engaged with the design and identified any usability issues or areas of improvement.
Key Insight form Testing
One significant pattern that emerged during the user testing sessions was related to the layout of the task details page. Users, including both monitors and site users, found it challenging to navigate the page efficiently. They had to scroll up and down the page repeatedly to answer form questions or address queries. This usability issue indicated a need to rethink the organization of information on the task details page.
Our users expressed a desire for a more streamlined experience where all the necessary information could be accessed within a single view. This insight highlighted the importance of reevaluating the layout design to enhance usability and ensure that users can easily access the information they need to perform their tasks effectively.
Iteration & Refinement
In response to user insights gathered during testing, we introduced a redesigned layout featuring a convenient side panel. This panel incorporates tabs for forms, queries, and document details, consolidating all essential information into one view.
Outcome & Impact
Effectiveness and Scalability of RSR Design Solutions
Despite being in the development phase, the design solutions implemented in RSR have already demonstrated their effectiveness and received positive feedback. During demonstrations to existing and prospective clients, the RSR prototypes garnered praise, leading to two organizations committing to switching from their current solutions to RSR upon its release. This validation highlights the impact of our design choices in addressing the needs and pain points of users in the clinical trial monitoring process.
Additionally, the success of RSR has inspired the adaptation of certain concepts and design patterns for a related application called Imaging. This adaptation reflects the scalability and versatility of our design approach, extending its benefits to other domains, such as managing and verifying clinical imaging data, including X-rays, MRI scans, ultrasound images, and more.
Conclusion
The RSR project transformed our understanding of the source review process in clinical trials. Through a meticulous discovery phase, we identified pain points and goals, developing tailored solutions. Automating task generation based on site visits freed monitors, while Site Documents streamlined document management for site staff. Queries eliminated inefficiencies caused by external communication channels.
The positive outcomes are remarkable. Clients responded enthusiastically, with two committing to switch from their current solutions to RSR. Our design concepts and patterns were adapted to the Imaging application, showcasing scalability and versatility.
Overall, RSR enhanced my skills and made a tangible impact. User-centered design streamlined workflows, fostered collaboration, and improved efficiency in clinical trials, shaping the future of healthcare and research.