Clinical Research Operations Program

The Clinical Research Operations Program offers classes specific to clinical research involving human subjects. The goal of the program is to raise the quality of clinical research across Stanford and to enhance the career growth of clinical research personnel. Class instructors include faculty and staff with clinical research expertise from across Stanford University.

SPECTRUM TRAINING CALENDAR

Benefits of Participation

Gain fundamental knowledge related to conducting clinical research in compliance with federal, state and local regulations
Prepare for Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SOCRA) certification exams
Enhance career growth and advancement

Stanford Clinical Research Operations Core Classes

Core classes provide practical information to develop and enhance clinical research operations and Good Clinical Practice (GCP) skills in core competency areas deemed essential to clinical and translational science by NCATS. Each of the core classes is offered several times per year.

Course Catalog

For information on upcoming classes and events, sign up to receive the bimonthly Education and Training Digest.

Adverse Event/Serious Adverse
Event Management

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Learn how to identify, report, and manage adverse events (AEs) and serious adverse events (SAEs) in clinical research.

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Clinical Trials .gov Overview

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A presentation of the criteria for study registration and the specific responsibilities that apply to Stanford clinical researchers.

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Ethics and
Clinical Research

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An overview of the ethical framework and an exploration of common ethical challenges in clinical research.

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General and IRB
Reporting Requirements

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This class highlights essential reporting requirements in clinical research to ensure ethical and regulatory compliance.

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Good Documentation Practices

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This class emphasizes maintaining accurate, consistent records and clear documentation to ensure research integrity and reproducibility.

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Overview of
Clinical Research Resources

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This class provides new clinical research staff with an introduction to navigating Stanford University's clinical research environment.

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Research
Billing

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Overview of the process to prevent billing participants for research services at Stanford Hospitals.

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Research Budgeting 1:
RMG Processes and
Estimating Costs

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Learn how to develop a budget customized to the unique requirements of clinical research.

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Research Budgeting 2:
The Budget and Billing Workbook

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This interactive session covers completing the mandatory Budgeting and Billing Workbook when research participants are seen SHC or SMCH.

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Study Essential Records
and the
Regulatory Binder

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This class examines the key elements of essential records in clinical research.

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Study Start-up

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This class outlines pre-enrollment requirements and offers resources and contacts to navigate Stanford's research process.

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Study Teams Roles and Responsibilities and the
Delegation of Authority

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This class will delve into the distinct roles and responsibilities of the various members of a clinical research study team.

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The Informed Consent Process

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This class provides a comprehensive overview of the ethical, legal, and practical aspects of the informed consent process.

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The Stanford IRB Process

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This class offers practical insights on when to submit to the Institutional Review Board (IRB), the necessary documentation, and strategies to streamline the approval process.

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Understanding Phases of Research
and Research Study Designs

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This class aims to clarify the phases of clinical research and the essential study designs involved, guiding participants through the progression from pre-clinical research to Phase IV studies.

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Stanford Clinical Research Operations Certification

Certification Requirements:

Be employed by Stanford University, Stanford Medicine Children's Health, or Stanford Health Care.
Complete and be current with CITI Group 7 and HIPAA trainings.
Create a record in REDCap and record program requirements: Clinical Research Operations Certification Dashboard.
Core class credit requirements:
1. Attend LIVE virtual class.
2. Complete the associated quiz within 30 days of participating in the class.
3. Complete the associated evaluation within 30 days of participating in the class.
Complete four elective classes (classes offered by SCCR, Lane Library, CCTO, or other School of Medicine classes qualify as electives).
Complete all class requirements within a 24-month period.
Take the Clinical Research Operations Certification exam and earn a passing score of 80%.

For questions regarding the Program or disability-related accommodations, please contact Spectrum Workforce Development at:
spectrum_training@lists.stanford.edu

Exam Registration

The Clinical Research Operations Certification Exam takes place twice during the year, in the Spring and Fall. Apply for the Certification Exam Via Your REDCap Dashboard.

Fall 2025