Clinical Trials Operations (CTO)

Training Courses for Clinical Research Investigators

Instructor-led and eLearning training courses are available for UCSF PIs*. The eLearning modules are available at any time, and instructor-led courses offerings are listed below. All courses are free of charge.

 

* All UCSF Principal Investigators (PIs; including Fellows, those training to become PIs), Department Managers (DMs), Department Administrators (DAs), and other comparable-level research team members are invited to attend any course from the Clinical Research Investigator series.

 

Retaking each course annually is recommended.

 

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

Upon registering, please be on the lookout for CTO Training communications and calendar invitations with Zoom links from [email protected].

Accessibility: UCSF welcomes everyone, including people with disabilities, to participate in clinical research staff trainings. To request a reasonable accommodation, please contact [email protected] as soon as possible.

 

Spring 2025

Day 1: Wednesday, April 2, 2025, between 9:00 AM - 2:00 PM

Time Topic
9:00 AM Welcome & Orientation
9:30 AM - 11:15 AM CTO 301: Recruitment & Informed Consent*
11:50 AM - 1:50 AM CTO 302: Adverse Events, Protocol Violations, & Incidents: Documentation & Reporting*
1:55 PM - 2:00 PM Review plan for "Day 2"
2:00 PM Adjourn

Day 2: Thursday, April 3, 2025, between 9:00 AM - 2:00 PM

Time Topic
9:00 AM - 9:05 AM Welcome
9:30 AM - 11:15 AM CTO 304: Hiring & Managing Research Staff
10:25 AM - 12:25 PM CTO 303a: Pre-Award Tasks*
1:55 PM - 2:00 PM Closing Remarks
2:00 PM Adjourn

Please note:

  • Course evaluations will be completed at the end of each module.
  • Short breaks will be held between each module.
  • A long break will be held about half-way through each day.
  • * Modules longer than an hour include a short break.
  • UC Learning requires registration for both days.
    • Once registration is complete, registrants are welcome to attend any modules.
  • We recommend attending all modules.
  • The Welcome and Orientation module on "Day 1" will provide helpful details for both days.

Audience: UCSF Principal Investigators (PIs; including Fellows and those training to become PIs), Department Managers, Department Administrators, and other comparable-level research team members.

Prerequisite: CTO 300e: Foundations of Clinical Research (highly recommended but not required).

Module descriptions: Module (course) descriptions are included below.

Fall 2025

Registration

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, determine which dates you wish to attend, and click ADD
  6. Then click REGISTER
  7. If you have questions, email [email protected]

CTO Clinical Research Investigator Foundations Intensive

The CTO Clinical Research Investigator Foundations Intensive is designed to provide foundational information and resources for PIs conducting clinical trials at UCSF. The material of the Intensive targets PIs, while clinical research staff, supervisors, and administrators seeking pertinent information are encouraged to participate in the CTO Foundations and Advanced series for Clinical Research study team members.

 

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

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

CTO 300e: Foundations of Clinical Research

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 covered topics.

 

Note: This eLearning module 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.

 

CTO 301: Recruitment & Informed Consent

CTO 301: Recruitment & Informed Consent

This course covers the essentials of study recruitment, informed consent form (ICF) preparation, informed consent discussions, and best practices for performing an informed consent discussion. Additional topics include re-consent, documentation of the consent process, and more.

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

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

This course covers best practices for Adverse Event (AE) recording, and IRB reporting requirements for AEs and Serious Adverse Events (SAEs), Post-Approval Events, and Subject Injury.

​​​​​

CTO 303a: Pre-Award Tasks

CTO 303a: Pre-Award Tasks

This course covers study start-up and finance topics, such as feasibility, working with the Office of Clinical Trial Activation (OCTA), coverage analysis (CA), budgeting, and other details important to PIs conducting interventional research studies using OnCore and APeX for billing procedures.

 

CTO 303b: Post-Award Tasks

CTO 303b: Post-Award Tasks

This course covers study and financial award set-up, purchase orders, clinical research billing compliance responsibilities, amendments, study closeout, and more.

 

CTO 304: Hiring & Managing Research Staff 

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.