eConsent
A seamless workflow for physicians to create, deploy, and monitor consent statuses of clinical study patients.
What is eConsent in Clinical Trials?
eConsent guarantees that trial participants receive thorough education about the trial procedures and requirements, ensuring their informed decision-making and voluntary enrollment.
Figma, Zeplin, Jira, Lottie
Tools used
Lead Designer
Role
Timeline
January - March 2023
Background
The objective of this project was to enhance the existing Minimum Viable Product (MVP) eConsent solution by incorporating the requirements of a new client and aligning with the fundamental functionalities expected in an electronic consent solution for clinical trials.
Research
I conducted a comprehensive audit of the existing MVP eConsent feature, reviewing past feedback from use cases and assessing the current development schema for possible technical constraints. Following the audit, I collaborated with team members to analyze findings, identify areas for improvement, determine project scope, and identify any additional research requirements.
Audit
Then I conducted a series of competitive analysis, examining how various products facilitate multiple users in creating and deploying sensitive documents for recipients' signatures:
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TransCeletate, Signant, Adavarra, Medable: Direct competitors that offer eConsent feature.
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Docusign: Arguably the most trusted platform to handle document creation, deployment, and version control.
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Adobe Acrobat: Comes with less configurations but supports offline document creation.
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Box sign: Highly configurable document creation feature as part of a cloud content management platform.
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Docugami: Document building and version controlling API
Although some are unrelated to clinical trials, these products establish the benchmark for document creation tools that users are accustomed to using. Through the competitive analysis, we recognized the level of sophistication required to meet this standard and prevent user frustrations.
Competitive Analysis
I collaborated with our in-house science team to conduct an in-depth exploration of the consenting process in clinical trials. We engaged clinicians to gather insights into their past experiences with obtaining consent from patients, their preferred methods for collecting consents, and any perceived pain points or challenges associated with the current process. Our key findings from the interviews are as follows:
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While eConsent is recognized as advantageous, clinicians are often unfamiliar with its implementation due to insufficient software onboarding.
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In-person paper consent processes typically require 30-45 minutes per patient, prompting clinicians to seek methods for expediting consent collection.
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Clinicians require a streamlined approach for monitoring patient consent statuses, as the current manual update process proves cumbersome.
User Interviews
Read-only Consents
The client spearheading this project conducted the clinical trial across multiple countries, some of which enforce regulations prohibiting the collection of electronic signatures. As a result, the platform must offer a "read-only" version of the consent to participants in select countries, enabling electronic consent deployment while adhering to country-specific regulations. These participants are required to review the consent independently and provide signatures in person during clinic visits.
Tiered Permission Per User Access Level
The platform must enable certain users to create and edit consent forms, while restricting others to solely viewing and deploying the forms. Additionally, all users should have visibility into the consent status of patients.
Contraints
Version Control
Clinical trials typically span several years, during which consent forms are frequently revised and distributed to both existing and new patients for signature. It is imperative that the system effectively tracks these edited versions and ensures the deployment of the most recent version to relevant users.
Usability Test
Following the design and development of the upgraded eConsent feature, we arranged 10 rounds of usability testing with clinicians and subject matter experts. These tests primarily aimed to validate the feature's ease of use, compliance with industry standards, and its potential integration into their daily workflows.
We then categorized the feedback and identified the most significant missed opportunities for updates to address before onboarding our client to the eConsent feature.
Current:
Consent creation flow does not include page formatting.
Feedback:
Header and footer configurations are often required for versioning the document.
Action item:
Create an optional step within the consent creation flow to customize header and footer.
Current:
Consent creation flow and consent deployment flow are two separate flows.
Feedback:
This causes unnecessary step within the consent flow.
Action item:
Consolidate the two flows into a single flow.
Current:
Leveraged existing design library
Feedback:
Some UI is not very clear and hard to assume its usage.
Action item:
Update the called out UI as a general improvement for the platform.
Opportunities to Address
Based on the findings from usability tests.
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Flexible Configuration as Core Value
We initiated design explorations centered on user flows validated by the client, prioritizing intuitive designs with familiar document-building patterns. Simultaneously, we maintained flexibility in consent creation and deployment configuration options.
Exploration + Iteration
Consent Table - Drafts
Monitor Consent Status
Written consents are saved under the "Drafts" tabs until users configure deployment schedule.
Clicking a row expands a drawer that shows consent status of all patients assigned to this consent.
Consent Builder - PDF Upload
User may upload a PDF copy of consent.
Consent Builder - Free Text Entry
User may copy & paste or type in the consent. Possible signees include participants, caregiver, physician, etc.
Combined Flows
Before
After
In the initial iteration, the consent creation and deployment were separated into two distinct flows, driven by concerns regarding the time required for each step. However, feedback and observations from the usability test revealed that the time taken was not as significant as initially anticipated. Consequently, we recognized that the separation of these steps could potentially lead to confusion and delays in the overall consent process. For the final iteration, we opted to consolidate the two flows, resulting in a reduction in the time spent completing the consent configuration task.
Final Iteration
Document Formatting
In light of the usability tests and advice from subject matter experts, we acknowledged the absence of header and footer customization as a significant oversight. Understanding its importance in the consent-building process for including version information, references, and other essential details, we promptly designed and developed this crucial feature. As a result, we successfully integrated it into the eConsent feature and met the scheduled timeline.
This feature represents the most intricate build I've undertaken for our clinician platform. The usability test highlighted numerous opportunities for further enhancements. Moving forward, we aim to explore an API solution that will enhance the flexibility of the consent creation process, enabling clinicians to track updates across different consent versions and gain clear insight into study changes.
Learnings and Next Steps
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Flexible Configuration as Core Value
Based on the research findings and the defined requirements from the client, we created user flows for consent creation, deployment, monitoring, and additional edge-cases to consider.
User Flow
Easier UI
After
Before
Throughout the usability test, we noticed that certain platform-wide UI elements were unfamiliar to many users accustomed to using other document-building software. In response, we revisited the competitive analysis conducted at the project's outset and evaluated the UI patterns employed by competitor platforms. Subsequently, we refined and adjusted our design system to align our platform's UI with other comparable document builders and clinical trial solutions.