Enable the Enrollment Journey

Learning Objectives

After completing this unit, you’ll be able to:

• Describe how to use orchestration capabilities for enrollment management.
  
• Explain how to collect eConsent with Participant Management.
  
• Describe the role of randomization in Participant Management.
  

Orchestrate Enrollment

Successful clinical trials depend on a well-orchestrated enrollment process. This means guiding users through a series of defined stages, from initial referral to final enrollment, while ensuring that all tasks are completed efficiently and accurately. With Life Sciences Cloud, you can use the platform’s flexible orchestration features to create structured workflows that define key milestones and actions for each stage of enrollment. Additionally, the system can automatically assign tasks to the appropriate users. This functionality streamlines the enrollment process, ensuring clarity and consistency for both clinical trial staff and participants.

Here are the main stages of a typical enrollment journey for clinical trials.

This table introduces the goal of each stage.

After defining each stage of the enrollment process, administrators configure corresponding workflows. These workflows can include task assignments for clinical trial recruiters and automatic notifications for participant milestones. A structured approach gives recruiters a clear overview of their responsibilities and a way to track each candidate's progress. The result is a streamlined enrollment process and a faster trial.

Let’s return to the example influenza trial and see how Cindy Singh, the clinical trial recruiter at Stay Healthy Clinic, uses Participant Management to handle key enrollment tasks.

Cindy spearheads recruitment efforts at her site, identifying and engaging potential participants. She guides them through informed consent, schedules screening appointments, and meticulously tracks enrollment metrics.

Accept Participants

After the sponsor portal confirms initial eligibility, the clinical site team leads the candidate through enrollment. The clinical trial coordinator acts as the gatekeeper, reviewing each candidate's profile on a centralized dashboard to assess eligibility based on prescreening data and medical history.

After Cumulus Pharma's portal confirms Milly’s eligibility for the influenza trial, the focus shifts to StayHealthy Hospital, which is the investigative site closest to her home. Cindy Singh steps in to guide Milly through enrollment.

To get things started, Cindy logs in to her Clinical Trials app, a custom interface designed for efficient trial management. There, she finds a list of all Research Study Candidates assigned to her.

Noticing that Milly is a new candidate, she opens her candidate record and reviews her Enrollment Lifecycle.

This component displays the key milestones of her enrollment journey, along with the tasks to be completed at each stage. Justus, our Salesforce admin, configured all these stages, tasks, and actions using various platform tools.

Cindy carefully reviews Milly’s details, confirms everything looks good, and accepts the candidate referral, preparing for the next critical step: obtaining Milly’s informed consent.

Collect Consent

Informed consent, a cornerstone of clinical research, ensures participants fully understand the study details, risks, and benefits. Participants review and sign consent forms, creating a clear, auditable record that protects all parties involved.

Participant Management streamlines this process with electronic consent (eConsent) functionality powered by prebuilt flows. This functionality simplifies consent form creation, delivery, and signing, ensuring regulatory compliance while improving the participant experience.

For the Cumulus influenza study, Justus configures the flows and custom sharing settings to support eConsent, allowing clinical trial coordinators to easily prepare and send consent forms.

First, he clones a prebuilt flow for creating and reviewing consent.

This comprehensive flow contains all the logic, assignments, actions, errors, and displays needed for clinical trial recruiters to easily create and review consent requests. To fit the desired workflow for the Cumulus consent process, Justus makes a few simple tweaks and then tests it to confirm it works as expected.

When the flow is activated, Cindy can send Milly an eConsent form directly from her research study candidate record.

Milly logs into the portal and reviews the eConsent form detailing the trial's purpose, procedures, and potential risks. Satisfied with the trial design, she signs the form electronically. Participant Management supports both scribble and user-credential types of e-signature.

Cumulus Pharma uses the user-credential e-signature type, which meets 21 CFR Part 11 compliance requirements. This more secure method requires signers to log in with their username and password, linking the signature to their identity.

Upon receiving notification of Milly’s consent, Cindy validates it in the system, ensuring all regulatory and ethical requirements are met.

Participant Management's automated eConsent process eliminates manual paperwork, reduces administrative burden, and ensures a secure and compliant approach to informed consent.

Schedule Screenings

After receiving consent for trial participation, the study team often conducts a more thorough final eligibility assessment, which may include medical examinations or additional tests. Use the robust scheduling features of the Salesforce Platform to coordinate final screenings—whether in-person or virtual—ensuring that only participants who meet all the criteria can proceed.

With Milly's consent secured, Cindy uses the intuitive Salesforce scheduling interface to find a time slot given Milly's availability and the clinic’s schedule. The interface shows a clear view of the calendars of all relevant staff members and resources, such as examination rooms or medical equipment, ensuring an efficient scheduling experience. Plus, with customized reminder notifications, Milly receives timely alerts for her upcoming screening, minimizing the risk of missed appointments and delays in the study.

Randomize Participants

With Milly’s screening appointment set, it's time for the next crucial step in the trial process: randomization.

In clinical trials, randomization is like a fair coin toss. It ensures that eligible participants, like Milly, are randomly assigned to different treatment groups, minimizing any bias and allowing researchers to confidently attribute observed differences to the treatment itself.

Participant Management supports various randomization techniques, including:

• Block randomization: Participants are divided into equal-sized blocks and randomly assigned to treatment groups within each block, ensuring balanced group allocation throughout the trial.
  
• Criteria-based block randomization: This approach combines block randomization with stratification. Researchers first group participants based on relevant characteristics, then apply block randomization within each stratum to achieve balanced distribution across treatment groups.
  

Typically, the administrator sets up the randomization system on the Salesforce Platform and makes the necessary data available to the randomization algorithm. After a participant is deemed eligible, the coordinator initiates randomization within the system, optionally blinding the process to further minimize bias. Additionally, if life sciences organizations employ a third-party randomization service, they can integrate this service with their enrollment orchestration.

For the Cumulus Pharma influenza trial, Justus configures the randomization system according to the study protocol, ensuring relevant data points are available for the algorithm.

As Cindy guides Milly through enrollment, they reach the randomization stage. Right within Milly's Research Study Candidate record, Cindy accesses the randomization tool. With just a few clicks, she initiates the process, and the system randomly assigns Milly to either the experimental drug or placebo group.

This automated randomization eliminates bias and ensures the integrity of the trial.

Complete Enrollment

With screening completed and randomization finalized, Cindy officially enrolls Milly in the trial. Milly begins her participation, receiving the assigned treatment, attending follow-up visits, and contributing valuable data to the study.

Together, their experiences demonstrate the transformative impact of Participant Management on clinical trial recruitment and enrollment. The solution accelerates the delivery of innovative treatments to patients, ensuring that no time is lost in getting critical drugs to market.

Throughout this module, you've gained a solid foundation for how this comprehensive solution addresses recruitment and enrollment challenges, empowers patients, and streamlines processes for clinical trial teams.

To further explore the full potential of Participant Management, check out the Resources.

Resources

• Salesforce Help: Clone and Activate a Flow for E-Consents
• Salesforce Help: Using Block Generation
• Salesforce Help: Set Up Block Randomization
• Salesforce Help: Set Up Criteria-Based Block Randomization
• Salesforce Help: Using Randomization to Anonymize Participant Allocation