Registering for Courses – 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 Training"
5. From the list, determine which courses/dates you wish to take, and click ADD
6. Then click REGISTER
7. If you have questions, email [email protected]

CTO 100: Orientation 

This course is the beginning of the CTO Foundations series for clinical research staff and study team members. It reviews the basic components of clinical research coordination and operations at UCSF, including research study team responsibilities, common tasks, and how research staff will work with UCSF partners in their day-to-day roles. The course introduces resources such as the HUB and IRB websites. The course also explores job basics including best practices for documentation, data security, the IRB review process, and more.

2025 Course Dates (all classes conducted on Zoom; please register via learning.ucsf.edu)

Course Prerequisite(s):

1. Complete HIPAA 101, and Human Subjects and GCP via CITI
2. Review the HUB, including Suggested Training List

Suggested Prerequisite(s): Research Integrity Video

​​​​Audience: Any clinical research study team members, including new and current CRCs.

CTO 101: Recruitment & Informed Consent + Workshop

Participant recruitment and informed consent are crucial aspects of clinical research and clinical trial enrollment. In this interactive course, we will cover the essentials of study recruitment, informed consent form (ICF) preparation, informed consent discussions, and practice performing an informed consent discussion. Additional topics include re-consent, documentation of the consent process, resources, and more.

Other Details: Please be ready to participate in the workshop where we will practice having the informed consent discussion! Bring a consent form for one of your studies (we will provide one if you do not have one).

2025 Course Dates (all classes conducted on Zoom; please register via learning.ucsf.edu)

Course Prerequisite(s): CTO 100

​​​​​​Audience: Any clinical research study team members, including new and current CRCs.

CTO 102: Adverse Events, Protocol Violations, & Incidents: Documentation & Reporting

This course will review Adverse Event (AE) recording best practices, including a demonstration of a participant interview with designated time for all to practice. The course will also discuss IRB reporting requirements including the following: AE and Serious Adverse Event (SAE) Reporting, Post-Approval Reporting, and Subject Injury.

2025 Course Dates (all classes conducted on Zoom; please register via learning.ucsf.edu)

Course Prerequisite(s): CTO 100

​​​​​​Audience: Any clinical research study team members, including new and current CRCs.

CTO 103: Pre & Post-Award Tasks

The pre-award section 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 research teams conducting clinical research using OnCore and APeX to manage study participant enrollment and visit activities. The post-award section covers financial award set-up, clinical research billing compliance responsibilities, amendments, study closeout, and more.

2025 Course Dates (all classes conducted on Zoom; please register via learning.ucsf.edu/)

Course Prerequisite(s):

1. Review the Start-Up Diagram and the Common Billing Tasks Checklist
2. CTO 100, CTO 101, CTO 102, CTO 107

Audience: Any clinical research study team members, including new and current CRCs, who have been in their role for at least 3 to 6 months.

CTO 104: Effective Communications + Workshop

Effective Communications are an essential component of protecting participant privacy, confidentiality, and developing positive relationships with your participants, supervisors, colleagues, non-UCSF collaborators (sponsors, clinical research organizations [CROs], etc.), and University-wide. In this course, we will discuss best practices for communicating with your participants, supervisors, partners at UCSF and beyond, and then workshop those skills.

Other Details: Please be ready to participate in the workshop where we practice using the tools presented in this course!

2025 Course Dates (all classes conducted on Zoom; please register via learning.ucsf.edu/)

Course Prerequisite(s): CTO 100, CTO 101, and CTO 102

Audience: Any clinical research study team members, including new and current CRCs.

CTO 105e: The Investigational New Drug Process

This course will describe how to identify if your study requires an IND, types of INDs, and the scope of the application process. It will also discuss how to handle IND modifications, safety reports, and annual reports.

The IND Process course is available at the UC Learning Center. To take it, either login to MyAccess and follow the link for UC Leaning Center (also called the Learning Management System) or follow this link. Once you are in the "Find a Course" section, search for “CTO 105e” or "Investigational New Drug Process".

Course Prerequisite(s): CTO 100, CTO 101, and CTO 102

Audience: Any clinical research study team members, including new and current CRCs, with responsibilities on Interventional Studies that include INDs.

CTO 106e: Data Management

This course will describe the origin, flow, and management of data through a clinical study, and the specific role of research study team members in each phase of the process from data design to analysis and reporting. The course will highlight best practices for data design, management, and analysis as well as how to implement processes for quality assurance and quality control. This course summarizes resources available at UCSF.

The Data Management course is available at the UC Learning Center. To take it, either login to MyAccess and follow the link for Learning Management System or follow this link. Once you are in the "Find a Course" section, search for "CTO 106e: Data Management".

Course Prerequisite(s): CTO 100, CTO 101, and CTO 102

Audience: Any clinical research study team members, including current new and current CRCs.

CTO 107: Clinical Research Systems

This course covers the basics of the three primary clinical research systems used by UCSF research study team members: iRIS (the online application system used to submit studies to the UCSF IRB), and OnCore (UCSF's clinical trial management system), and APeX (UCSF's electronic medical record system).

2025 Course Dates (all classes conducted on Zoom; please register via learning.ucsf.edu/)

Course Prerequisite(s):

1. Review the Common Billing Tasks Checklist
2. CTO 100, CTO 101, and CTO 102

Suggested Prerequisite(s): Obtain access to OnCore and complete the required trainings: OnCore Access and Training | Office of Clinical Trial Activation (ucsf.edu).

Audience: Any clinical research study team members using iRIS for IRB submissions, and/or OnCore and/or APeX to manage study participant enrollment and visit activities, and clinical research billing compliance.

CTO 201: Monitoring & Audit Readiness + Workshop

Part of the Advanced series, this interactive training plus workshop focuses on the purpose and process for monitoring and audits in clinical research. We will describe best practices then have break-out group activities to help you prepare for monitoring and audits.

Other Details: Please be ready to participate in the workshop where we practice using the tools presented in this course!

2025 Course Dates (all classes conducted on Zoom; please register via learning.ucsf.edu/)

Course Prerequisite(s): CTO 100, CTO 101, CTO 102, CTO 103, CTO 104, CTO 107

Audience: Experienced clinical research study team members who have been in their role for at least 6 months, who work on studies that may involve monitoring or auditing activities.

CTO 203: Coverage Analysis Guidance & Concepts

Coverage Analysis Guidance and Concepts is an advanced series course that reviews the importance of a coverage analysis (CA), determining when a CA is required, how to successfully work with your analyst, reviewing the coverage analysis and providing study team sign-off, and understanding how the coverage analysis works.

This course is especially applicable for those working on industry sponsored clinical trials with the Office of Clinical Trial Activation (OCTA).

2025 Course Dates (all classes conducted on Zoom; please register via learning.ucsf.edu/)

Course Prerequisite(s): For staff new to clinical trial start-up at UCSF, CTO 103: Pre & Post-Award Tasks is highly recommended along with reviewing: How to Activate a Study with Us | Office of Clinical Trial Activation (ucsf.edu).

Audience: Clinical research study team members who work on clinical trials with the Office of Clinical Trial Activation. This training is required for any staff member delegated by the PI to approve the draft coverage analysis and internal budget. Delegation of this responsibility is at the discretion of the PI's department.

CTO 204: Clinical Trial Budgeting Guidance & Concepts

Trial Budgeting Guidance and Concepts is an advanced series course that reviews components of a clinical trial budget, how to successfully work with your analyst, reviewing the internal budget and providing study team sign-off, and understanding negotiations strategies with industry partners.

2025 Course Dates (all classes conducted on Zoom; please register via learning.ucsf.edu)

Course Prerequisite(s): For staff new to clinical trial start-up at UCSF, CTO 103: Pre & Post-Award Tasks is highly recommended along with reviewing: How to Activate a Study with Us | Office of Clinical Trial Activation (ucsf.edu).

​​​​​Audience: Clinical research study team members who work on clinical trials with the Office of Clinical Trial Activation. This training is required for any staff member delegated by the PI to approve the draft coverage analysis and internal budget. Delegation of this responsibility is at the discretion of the PI's department.

CTO Refresher Courses

These refresher courses are intended for research staff who have previously taken CTO 101 & 102 training courses.

1. Online Refresher Courses (click on the LMS "Find A Course" box and search for course name)
   1. CTO Foundations - Informed Consent: Refresher
   2. CTO Foundation - IRB and Safety Reporting: Refresher

OnCore Training & Account Request

• Sign up for an OnCore account

Additional Resources​​​​​​

1. CRC Listerv - all CRCs and study team members are strongly encouraged to sign up for the CRC listserv to ensure they receive pertinent communications. To enroll, send a one-line email with no subject to [email protected]. The one line of the message is: subscribe CLINRESCOORD firstname lastname (firstname lastname are your first and last names.) Delete all other content from the body of the message. The listserv server will pull your email address from the FROM field of your email. You then should receive a confirmation request email to confirm your intention to subscribe to the listserv. Upon confirming your subscription, you will receive a welcome/acceptance message stating that your subscription request has been accepted.
2. Suggested Training Checklist
3. List of Acronyms
4. Common Billing Tasks Checklist
5. Study Start-Up Diagram (Industry)
6. Study Start-Up Checklist
7. Note to File