Greater San Diego Chapter: Beyond the Protocol - Amplifying the Patient Voice in Clinical Research

When:  Mon, Sep 21, 2026 from 05:30 PM to 07:30 PM (PT)
Associated with  ACRP Greater San Diego Chapter

Greater San Diego Chapter: Beyond the Protocol - Amplifying the Patient Voice in Clinical Research 

 
This is a in-person event
 
Location:
Aquillius
10918 Technology Pl
San Diego, CA 92127 
 
Event Description:
Beyond the Protocol: Amplifying the Patient Voice in Clinical Research explores how meaningful patient and caregiver engagement can move clinical research beyond regulatory compliance toward studies that are more ethical, feasible, relevant, and patient-centered. Speakers will share perspectives shaped by lived experience, patient advocacy, and innovation, examining how the patient voice can inform research from study design and informed consent through trial participation and results communication.
 
The program will explore the evolving regulatory landscape, including FDA Patient-Focused Drug Development initiatives and ICH E8(R1), while distinguishing regulatory expectations from meaningful engagement practices. Speakers will also address practical approaches to partnering with patient advocacy organizations, improving patient-facing materials through digital innovation, and navigating privacy, HIPAA, security, and ethical considerations surrounding patients' access to their own clinical study information.
 
Participants will leave with practical strategies for incorporating the patient perspective throughout the clinical research lifecycle and a deeper understanding of why patients should be viewed not simply as participants in research, but as partners with expertise essential to designing research that matters.
 
Speakers:
  • Michele Baptista, Sr. Director Business Development, Univo IRB
  • Kristi Clark, Executive Consultant, Clinical Operations 
Learning Objectives:
  1. Apply practical strategies to elevate the patient voice within their own clinical research programs, moving beyond compliance toward research that is more patient-centered, feasible, ethical, and meaningful.
  2. Differentiate regulatory requirements from emerging best practices for incorporating patient perspectives into clinical research, including the FDA Patient-Focused Drug Development framework and ICH E8(R1). 
  3. Recognize common barriers to meaningful patient engagement, including health literacy, accessibility, technology, privacy, regulatory requirements, and the practical burden of clinical trial participation. 
  4. Describe how patient advocacy organizations and other patient-focused resources can support study design, participant engagement, and more representative clinical research.
  5. Evaluate the ethical considerations surrounding patient access to clinical study information and results, including the balance between transparency, patient autonomy, privacy, HIPAA, and data security. 
 
Registration Information:
This event is free to attend. Click here to register by 9/21/26. Each attendee is required to have their own registration – only one registration per transaction. No refunds will be provided.
 
After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer.
 
The educational portion of this event may be self-reported as 1 point toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.

Location

Aquillius
10918 Technology Pl
San Diego, CA 92127
Event Image

Contact



mbaptista@univo-group.com