Clinical Trials Operations Principal Investigator (PI) Intensive

CTO is undergoing a transition. In the meantime, many trainings, Research Forums, and research navigation services will continue. Please contact [email protected] with any questions.

Training Courses for Clinical Research Investigators

Instructor-led courses and eCourses are available for UCSF PIs*. All courses are free of charge.

Who should attend these trainings?

* All UCSF Principal Investigators (PIs) and similar roles, including but not limited to:

  • Fellows,  
  • those training to become PIs,
  • department or division administrators (DAs),
  • department or division managers (DMs),
  • other comparable-level research team members.  

Clinical research staff and study team members should participate in the CTO Foundations and Advanced series.  

When should each course be attended?

Retaking each course every two years, or as needed/desired for continuing education, is recommended.  

What else should you know?

Course schedule is subject to change, at the discretion of the Training Team.

Register at learning.ucsf.edu; see below for detailed instructions.

Logistics: After registering, monitor your inbox for a confirmation email from the UC Learning Center, which will include a calendar invitation with Zoom details. If you do not receive that email, contact [email protected].    

Accessibility: UCSF welcomes all participants to our events. If you need a reasonable accommodation to participate in this event because of a disability, please contact [email protected] as soon as possible.

Registering for CTO Clinical Research Investigator Foundations Intensive – Detailed Instructions
  1. Go to the UC Learning Center: https://learning.ucsf.edu/
  2. Login using your MyAccess credentials (required even if you are already logged into MyAccess)
  3. Click the Search icon
  4. Search for "CTO PI Intensive" or click here for the direct link
  5. From the list, find the PI Intensive offering, and click ADD
  6. Then click REGISTER
  7. If you have questions, email [email protected]

What courses are part of this series?

eCourse

CTO 300e: Foundations of Clinical Research (Online | On-demand)

This course reviews the foundations of clinical research at UCSF for PIs, including top PI responsibilities, best practices for protocol writing, training, manual of operations and procedures (MOPs), standard operating procedures (SOPs), documentation, checklists, and more. The course introduces resources for each of the topics covered.

Note: This eCourse may be completed at any time, outside of the CTO Clinical Research Investigator Foundations Intensive training series.

 

Completing CTO 300e: Foundations of Clinical Research shortly before the instructor-led Intensive begins is highly recommended.

 

Take the course: CTO 300e: Foundations of Clinical Research

 

CTO Clinical Research Investigator Foundations Intensive 

The CTO Clinical Research Investigator Foundations Intensive (a.k.a. PI Intensive) provides foundational information and resources for PIs conducting clinical trials at UCSF.  

Instructor-led sessions are conducted on Zoom. Attending all modules is recommended, but not required.

For all courses below: Resources for the covered topics will be provided.

Course Descriptions

 

Before PI Intensive
CTO 300e: Foundations of Clinical Research (Online | On-demand)
This course reviews the foundations of clinical research at UCSF for PIs, including top PI responsibilities, best practices for protocol writing, training, manual of operations and procedures (MOPs), standard operating procedures (SOPs), documentation, checklists, and more. Resources for each topic are provided. Complete it here: CTO 300e: Foundations of Clinical Research.
Day 1

CTO 304: Hiring & Managing Research Staff 
This course covers the role of research study team staff, best practices for estimating the amount and type of support needed for a research study, guidelines for sharing research staff effort with other PIs, navigating recruitment and onboarding, and managing study team staff.

CTO 303a: Pre-Award Tasks 
This course covers basics of, and tips and tricks for, Pre and Post-Award tasks. Topics include: feasibility, pre-submission, study start-up, working with institutional partners including the Office of Clinical Trial Activation, coverage analysis, budgeting, and other details important to PIs conducting interventional research studies.

CTO 303b: Post-Award Tasks 
This course provides a brief overview of study and financial award set-up, purchase orders, amendments, clinical research billing compliance responsibilities, study closeout, and more.

Day 2

CTO 301: Recruitment & Informed Consent + Workshop
This course covers the essentials of study recruitment, informed consent form (ICF) preparation, and best practices for performing an informed consent discussion. Additional topics include re-consent, documentation of the consent process, and more. Important details: 

  • Homework is required! One week before the session, registrants will be sent preparation materials to review independently.
  • The in-training module will consist of a brief overview of the most-important details followed by a 1-hour workshop where attendees will practice conducting the informed consent discussion.
  • Bring an IRB-approved consent form for one of your studies for the workshop (we will provide one if you do not have one).
  • If you register less than one week before the session, please email us to ensure you are sent the preparation materials.

CTO 302: Adverse Events, Protocol Violations, & Incidents: Documentation & Reporting 
This course covers best practices for identifying, documenting, and reporting (when necessary) the following occurrences: Adverse Events, Protocol Violations & Research Incidents, and other Safety-Related Information. It includes a review of the UCSF IRB’s requirements for reporting events and addresses how IRB reliances may impact reporting requirements.

Day 3

Best Practices in Community Engagement for Health Equity 101 
This course is an interactive, introductory conversation focused on the foundational principles of meaningful community-engaged research. It explores the importance of positionality; clarifying the “who” and “why” of community engagement; and discusses best practices for identifying, approaching, and sustaining partnerships with vested community partners. CTSI’s Community Engagement Toolkit and consultation services are introduced, highlighting practical strategies attendees can use to strengthen inclusive research practices and deepen authentic collaboration with community.

  • Audience: UCSF Principal Investigators (PIs; including Fellows and those training to become PIs), Department Managers, Department Administrators, and other comparable-level research team members; Research Staff and Study Team Members, including Clinical Research Coordinators; and other early-career research professionals.
Fall 2026

Instructor-led Courses

CTO 302: Adverse Events, Protocol Violations, & Incidents: Documentation & Reporting

​​​​​This course covers best practices for identifying, documenting, and reporting (when necessary) the following occurrences: Adverse Events, Protocol Violations & Research Incidents, and other Safety-Related Information. It includes a review of the UCSF IRB’s requirements for reporting events and addresses how IRB reliances may impact reporting requirements.

CTO 303a: Pre-Award Tasks

This course covers basics of, and tips and tricks for, Pre and Post-Award tasks. Topics include: feasibility, pre-submission, study start-up, working with institutional partners including the Office of Clinical Trial Activation, coverage analysis, budgeting, and other details important to PIs conducting interventional research studies.

CTO 303b: Post-Award Tasks

This course provides a brief overview of study and financial award set-up, purchase orders, amendments, clinical research billing compliance responsibilities, study closeout, and more.

CTO 304: Hiring & Managing Research Staff

This course covers the role of research study team staff, best practices for estimating the amount and type of support needed for a research study, guidelines for sharing research staff effort with other PIs, navigating recruitment and onboarding, and management of staff, emphasizing the clinical research coordinator (CRC) role.