Clinical Trials Operations (CTO)

Training for Clinical Research Staff

Instructor-led and eLearning courses are available for UCSF Clinical Research study team members. The eLearning modules are available at any time, and instructor-led courses are offered monthly, with the exception of August and December. All courses are free of charge.

Registration is open and available on the UC Learning Center at training.ucsf.edu; see below for detailed instructions.

Registering for Courses - Detailed Instructions

  1. Go to the UC Learning Center: https://training.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 Foundations

CTO 100: Orientation     

CTO 100: Orientation 

This workshop is the beginning class in the series. It reviews the basic components of the CRC role at UCSF. The first section focuses on the CRC responsibilities, common tasks, and how CRCs will work with UCSF partners in their day-to-day roles. The session also introduces resources such as the HUB and IRB website. The second section explores job basics including Best Practices for Documentation, Data Security, IRB, Coverage Analysis and the concept of Study Start Up.

2024 Course Dates (all classes conducted on Zoom; please register via training.ucsf.edu)

CTO 100: Orientation

January 22, 8.30am – 11am

February 26, 8.30am – 11am

March 25, 8.30am – 11am

April 22, 8.30am – 11am

May 27, 8.30am – 11am

June 24, 8.30am – 11am

July 22, 8.30am – 11am

September 23, 8.30am – 11am

October 28, 8.30am – 11am

November 18, 8.30am – 11am

Course Prerequisites:

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

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

CTO 101: Recruitment & Informed Consent

CTO 101: Recruitment & Informed Consent

Informed Consent is a critical part of the CRC role. In this interactive class we will demonstrate and practice performing an informed consent. Additional topics include the Informed Consent Process and Documentation.

Please be ready to participate! Remember to have your own study consents for practice (or we will provide if you don’t have one).

2024 Course Dates (all classes conducted on Zoom; please register via training.ucsf.edu)

CTO 101: Recruitment & Informed Consent

January 23, 12.30pm – 3.30pm

February 27, 12.30pm – 3.30pm

March 26, 12.30pm – 3.30pm

April 23, 12.30pm – 3.30pm

May 28, 12.30pm – 3.30pm

June 25, 12.30pm – 3.30pm

July 23, 12.30pm – 3.30pm

September 24, 12.30pm – 3.30pm

October 29, 12.30pm – 3.30pm

November 19, 12.30pm – 3.30pm

Course Prerequisites:

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

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

CTO 102: IRB & Safety Reporting

CTO 102: IRB & Safety Reporting 

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

2024 Course Dates (all classes conducted on Zoom; please register via training.ucsf.edu)

CTO 102: IRB & Safety Reporting

January 25, 8.30am – 12pm

February 29, 8.30am – 12pm

March 28, 8.30am – 12pm

April 25, 8.30am – 12pm

May 30, 8.30am – 12pm

June 27, 8.30am – 12pm

July 25, 8.30am – 12pm

September 26, 8.30am – 12pm

October 31, 8.30am – 12pm

November 21, 8.30am – 12pm

Course Prerequisites:

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

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

CTO 103: Pre & Post Award Tasks for CRCs                         

CTO 103: Pre & Post Award Tasks for CRCs

The pre-award section of this class covers study start-up and finance topics important to CRCs conducting interventional research studies using APeX and OnCore for billing procedures. The post-award section covers ZZ statements and research billing with a focus on coverage analysis and its impacts on the research process.

2024 Course Dates (all classes conducted on Zoom; please register via training.ucsf.edu)

CTO 103: Pre and Post Award Tasks
December 11, 2023, 9am – 12:30pm
January 8, 9am – 12.30pm
February 5, 9am – 12.30pm
March 4, 9am – 12.30pm
April 8, 9am – 12.30pm
May 6, 9am – 12.30pm
June 10, 9am – 12.30pm
July 8, 9am – 12.30pm
September 9, 9am – 12.30pm
October 7, 9am – 12.30pm
November 4, 9am – 12.30pm
December 9, 9am – 12.30pm

Audience: New or current CRCs with responsibilities on interventional studies.
Prerequisites: Review the Start-Up Diagram and the Job Aid: Common Billing Tasks.

CTO 104: Effective Communications                   

CTO 104: Effective Communications

Effective Communications are an essential component of protecting participant privacy, confidentiality, and for developing positive relationships with your participants, supervisor, colleagues and University-wide. In this course we will discuss best practices for communicating with your participants, supervisors and partners at UCSF.

2024 Course Dates (all classes conducted on Zoom; please register via training.ucsf.edu)

CTO 104: Effective Communications
February 26, 12pm – 1.30pm
March 25, 12pm – 1.30pm
April 22, 12pm – 1.30pm
May 27, 12pm – 1.30pm
June 24, 12pm – 1.30pm
July 22, 12pm – 1.30pm
September 23, 12pm – 1.30pm
October 28, 12pm – 1.30pm
November 18, 12pm – 1.30pm

Audience: New or current CRCs.
Prerequisites: None.

CTO 105e: The Investigational New Drug Process (Online | On-demand)

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.

This course is available on 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 the course name.

Audience: New or current CRCs with responsibilities on Interventional Studies.
Prerequisites: None.

CTO 106e: Data Management (Online | On-demand)

CTO 106e: Data Management

This course will describe the origin, flow and management of data through a clinical study, and the specific role of the CRC in each phase of the process from data design to analysis & 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 will summarize resources available at UCSF.

This course is available on 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 the course name.

Audience: Current CRCs.
Prerequisites: CTO Foundations Courses: CTO 100, CTO 101 and CTO 102.

CTO 107: Clinical Research Systems                       

CTO 107: Clinical Research Systems

This new class covers the basics of the three primary clinical research systems used by UCSF CRCs: iRIS (the online application system used to submit studies to the IRB), APeX (UCSF's electronic medical record system), and OnCore (UCSF's clinical trials management system). 

2024 Course Dates (all classes conducted on Zoom; please register via training.ucsf.edu)

CTO 107: Clinical Research Systems
December 11, 2023, 2pm – 4pm
January 8,  2pm – 4pm
February 5, 2pm – 4pm
March 4,  2pm – 4pm
 April 8,  2pm – 4pm
May 6,  2pm – 4pm
June 10,  2pm – 4pm
July 8,  2pm – 4pm
September 9, 2pm – 4pm
October 7, 2pm – 4pm
November 4,  2pm – 4pm
December 9, 2pm – 4pm

Audience: New or current CRCs using iRIS for IRB submissions and tracking and/or conducting interventional research studies using APeX and OnCore for billing procedures
Prerequisites: Review the Job Aid: Common Billing Tasks.

CTO Advanced

CTO 201: Monitoring & Audit Readiness Workshop

CTO 201: Monitoring & Audit Readiness Workshop

This hands-on advanced training workshop focuses on the purpose and process for monitoring and audits in clinical research. We will describe best practices and provide checklists and break-out group activities to help you prepare in the event of an audit. The target audience is advanced CRCs that have completed studies involving monitoring, or those who may experience auditing activities.

2024 Course Dates (all classes conducted on Zoom; please register via training.ucsf.edu)

CTO 201: Monitoring & Audit Readiness Workshop
April 15, 9am – 12pm

Audience: CRC with some study experience.
Prerequisites: CTO Foundations Courses: CTO 100, CTO 101 and CTO 102 are highly recommended.

CTO 202: Protocol Training, MOPs & SOPs (Online | On-demand course coming soon!)

Protocol Training, MOPs & SOPs is an advanced series course that reviews protocol training fundamentals, manual of procedure (MOP) & standard operating procedure (SOP) functions and best practices for creation and maintenance thereof. This course is especially applicable for those working on NIH-sponsored Investigator-initiated clinical trials or studies where UCSF is the coordinating center.

2023 Course Dates: this course being converted to online | on-demand; information on how to access coming soon

Audience: Experienced CRCs who have been in their role for at least 1 year.
Prerequisites: CTO Foundations Courses: CTO 100, CTO 101 and CTO 102 are highly recommended.

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.

2024 Course Dates (all classes conducted on Zoom; please register via training.ucsf.edu)

CTO 203: Coverage Analysis Guidance & Concepts
Jan 9, 10am – 11:15am
Feb 6, 10am – 11:15am
Mar 5, 10am – 11:15am

Audience: CRCs, Clinical Research Supervisors/Managers, and PPMs 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.

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

CTO 204:  Clinical Trial Budgeting Guidance & Concepts

Clinical 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.

2024 Course Dates (all classes conducted on Zoom; please register via training.ucsf.edu)

CTO 204: Clinical Trial Budgeting Guidance & Concepts
Jan 9, 1pm – 2:15pm
Feb 6, 1pm – 2:15pm
Mar 5, 1pm – 2:15pm

​​​​​Audience: CRCs, Clinical Research Supervisors/Managers, and PPMs who work on industry sponsored 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.

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

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

Additional Resources for CRCs

  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. CRC Suggested Training Checklist
  3. List of Acronyms
  4. Job Aid: Common Billing Tasks
  5. Study Start-Up Diagram (Industry)
  6. Study Start-Up Checklist
  7. Note to File