Clinical Trials Operations Training

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]

Orientation starts the CTO Foundations series. This course reviews basic components of clinical research coordination and operations at UCSF, including research staff and study team responsibilities, introductions to UCSF partners, and tips for working with those groups. It presents important resources such as the Clinical Research Resource HUB and Institutional Review Board (IRB) websites, and covers details and best practices for job basics such as documentation, data security, privacy protection, the IRB review process, regulatory tools, and more. 

Course Prerequisites:

1. Complete HIPAA 101, and Human Subjects and GCP via CITI
2. Review the HUB, including the Suggested Training List
3. Suggested Prerequisite: Research Integrity Video 

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

This course is conducted on Zoom; register via learning.ucsf.edu.

Course Dates & Times

Participant recruitment and informed consent are crucial aspects of clinical research and trial enrollment. In this interactive course, we cover the essentials of, and best practices for, study recruitment, informed consent form (ICF) preparation, and conducting informed consent discussions. Attendees then have a practice discussion in the workshop. Additional topics include re-consent, documentation of the consent process, resources, and more.

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

Course Prerequisite(s): CTO 100

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

This course is conducted on Zoom; register via learning.ucsf.edu.

Course Dates & Times

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. Class participants will fill out an Adverse Event Log together.

Course Prerequisite(s): CTO 100

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

This course is conducted on Zoom; register via learning.ucsf.edu.

Course Dates & Times

This course covers the 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, study and participant management in OnCore and APeX, award set-up, amendments, clinical research billing compliance responsibilities, study closeout, and more.

Course Prerequisites:

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

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

This course is conducted on Zoom; register via learning.ucsf.edu.

Course Dates & Times

Effective Communications are an essential component of day-to-day work in clinical research; from protecting participant privacy and confidentiality, to developing and maintaining positive relationships with participants, supervisors, colleagues, University-wide associates, and non-UCSF collaborators such as sponsors, clinical research organizations (CROs), and more. In this course, we discuss best practices and techniques, considerations, and workshop those skills.

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

Course Prerequisites: CTO 100, CTO 101, and CTO 102

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

This course is conducted on Zoom; register via learning.ucsf.edu.

Course Dates & Times

This course describes how to identify if your study requires an IND, types of INDs, and the scope of the application process. It also discusses 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 Prerequisites: CTO 100, CTO 101, and CTO 102

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

This course describes 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. It highlights best practices for data design, management, and analysis, how to implement processes for quality assurance and quality control, and 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 Prerequisites: CTO 100, CTO 101, and CTO 102

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

This course provides introductions to, and overviews of, the three primary clinical research systems used by UCSF research study team members:

• iRIS/Huron (the online application system used to submit studies to the UCSF IRB),
• OnCore (UCSF's clinical trial management system), and
• APeX (UCSF's electronic medical record system).

The system modules may be attended individually and are presented as follows:

1. Hour one: iRIS/Huron.
2. Hour two: OnCore.
3. Hour three: APeX.  

Course Prerequisites:

• Review the Common Billing Tasks Checklist
• CTO 100, CTO 101, and CTO 102
• Suggested Prerequisite: Obtain access to OnCore and complete the required trainings: OnCore Access and Training | Office of Clinical Trial Activation (ucsf.edu)

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

This course is conducted on Zoom; register via learning.ucsf.edu.

Course Dates & Times

Part of the Advanced series, this interactive training focuses on the purposes and processes for monitoring, inspections, and audits in clinical research. It reviews the importance of research oversight, study team roles, guidelines, best practices, and resources. Apply those details in the interactive workshop where you’ll be in the role of a monitor!

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

Course Prerequisites: CTO 100, CTO 101, CTO 102, CTO 103, CTO 104, CTO 107

Audience: Experienced clinical research staff and 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.

This course is conducted on Zoom; register via learning.ucsf.edu.

Course Dates & Times

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 the Office of Clinical Trial Activation (OCTA) when reviewing the CA and providing study team sign-off, and understanding how the CA works.

Course Prerequisites:

1. CTO 103 (for staff new to clinical trial start-up at UCSF)
2. Review OCTA’s How to Activate a Study with Us webpage

Audience: Clinical research staff and study team members who work on clinical trials that generate charges in the Electronic Medical Record. This training is required for any staff member delegated by the Principal Investigator to approve the draft coverage analysis and internal budget. Delegation of this responsibility is at the discretion of the PI's department.

This course is conducted on Zoom; register via learning.ucsf.edu.

Course Dates & Times

Clinical Trial Budgeting Guidance and Concepts is an advanced series course for studies supported by the Office of Clinical Trial Activation (OCTA). This course reviews components of an industry clinical trial budget, how to successfully work with OCTA when reviewing the internal budget and providing study team sign-off and understanding negotiations strategies with industry partners.

Course Prerequisites:

1. CTO 103 (for staff new to clinical trial start-up at UCSF)
2. Review OCTA’s How to Activate a Study with Us webpage

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

This course is conducted on Zoom; register via learning.ucsf.edu.

Course Dates & Times

This eCourse 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.

The eCourse is designed for PIs and is also helpful for clinical research staff and study team members interested in learning more about these topics.

Complete it anytime: CTO 300e: Foundations of Clinical Research

Course Prerequisites: CTO 100, CTO 101, CTO 102, CTO 103, CTO 104, CTO 107

Audience: Experienced clinical research staff and study team members who have been in their role for at least 6 months. 

• Sign up for an OnCore account

1. CRC Listserv - 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. List of Common Research Acronyms
3. Study Start-Up Diagram (Industry)
4. Study Start-Up Checklist
5. Note to File