FDA & REGULATORY
FUNDAMENTALS
Roberta Alexander
2026 Design and Management of
Cancer Clinical Trials Course
Distributed by:
RA

Issued to

Roberta Alexander

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Credential Verification

Issue date: October 13, 2026

ID: eebada35-e9a3-43a9-86ed-e025b1f3e8ea

Sylvester Comprehensive Cancer Center logo

Issued by

Sylvester Comprehensive Cancer Center

The University of Miami Sylvester Comprehensive Cancer Center is the only National Cancer Institute-designated cancer center in South Florida and is known as South Florida’s leader in patient-focused cancer research and care.

Type

Course

Format

Online

Description

The Sylvester Design and Management of Cancer Clinical Trials Course provides key information to advance translational clinical research, foster better clinical trial design, and ultimately improve patient care. Clinical research education works best when people learn together—not in silos. This course brings the full research team together, including PIs, advanced practice providers, nurses, clinical research coordinators, regulatory and lab staff, other clinical research professionals, PhD scientists, and trainees at all levels. Participants gain a strong foundation in cancer clinical research, and by learning in a shared virtual environment, attendees build common understanding, strengthen teamwork, and become better equipped to collaborate for clinical trial success. Holders of this badge gained robust insights into the history, purpose, and responsibilities of the FDA; the FDA approval process and investigator responsibilities; best practices and procedures to protect research participants and enhance reliability of collected data; and how to successfully collaborate with international clinical research colleagues.

Skills

Clinical Research

Cancer Clinical Trials

Regulatory Process

Regulatory Requirements

International Clinical Trials

Earning Criteria

Participation

Attended lectures and panel discussions on the road to regulatory approval, interacting with the FDA, and international clinical trials infrastructure and collaboration.