Spectrum provides education and training programs for staff who are engaged in the conduct and support of clinical research.
- See "My Training Requirements Checklist" on this page for optional and required training.
- Spectrum Training Calendar
The Orientation to Conducting Clinical Research at Stanford (CTR General Orientation) is an informative introduction and review of the clinical research process at Stanford University. Designed for new clinical research personnel, the orientation is comprised of two hours of instruction.
- Provide resources to manage and coordinate clinical research at Stanford University
- Review university departments involved in research (IRB, RMG, OSR)
- Understand key contacts, processes and documentation (Maintaining a Regulatory Binder, Stanford Clinical Trials website, Hospital Ancillary Services, Epic, CTRU, HIMS)
- Orientation assists new clinical research personnel navigate the Stanford clinical and translation research (CTR) process.
- Orientation is offered on the second Tuesday of the month.
- Required for new employees who are working in clinical research; recommended for postdoctoral scholars and faculty.
CITI training is required human subjects training for all staff working on a research project (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting of a research project).
Stanford provides access to the required training through an interactive online tutorial, the Collaborative Institutional Training Initiative (CITI) Course in the Protection of Human Research Subjects.
CITI offers a Basic (initial) course and then a Refresher course which must be taken every two years.
- CITI training is required (without exception)
- Key personnel is defined in the University Research Policy Handbook.
Administrators Building Competencies in Research — ABC Research
The ABC Research Meeting is offered by the Office of Research Administration. This quarterly meeting provides important updates regarding changes to Stanford policy related to research, and to sponsor forms, systems, and requirements.
Visit the ABC Research website for the following:
- Get meeting schedule.
- Subscribe to the ABC Research distribution list.
- Access handouts from past meetings.
- Please register for this meeting in the STARS training system - this helps us with set up! From the STARS Home, type "ABC" in the Search Catalog Field and click the [Search] button. When the class is returned, select "All Options" and select the activity for the next session.
The goal of the Cardinal Curriculum is to develop Stanford's research administration workforce by providing tools for individuals to build competencies, increase efficiency, and improve compliance with Stanford and sponsor requirements. The certification program ensures a standard level of expertise among those who support the research endeavor at Stanford University.
Cardinal Curriculum training classes, which can lead to certification, are organized into two levels and are geared to individuals as they develop from novice to expert in research administration. Level I classes should be completed before attempting Level II classes. The ORA Training and Development Office tracks and awards certification.
Who can benefit from these classes?
Research administrators and all administrative staff who support sponsored research including:
- individuals involved with proposal preparation
- individuals who originate or approve transactions on sponsored accounts
- individuals who review or monitor expenditures on sponsored projects.
If you have questions, email or phone Lisa Teresi-Forgatsch, Office of Research Administration, at 725-9830.
The Cancer Clinical Trials Office provides regulatory, administrative, research, and educational services to Cancer Center investigators conducting clinical trials.
Activities of the CCTO include:
- Centralized regulatory, financial and administrative support to all Cancer Center investigators
- Research support services for cooperative group and investigator initiated studies
- Centralized and standardized data collection and reporting of clinical research
- Programs to contribute to quality assurance of performance and the ongoing education of Cancer Center clinical research personnel
- Coordination of outreach efforts in the Community to increase clinical trials awareness and accrual
- Promotion of interdisciplinary collaborations and translational medical research
Director — Miriam Bischoff, MS, MBA, (650) 498-4536
Executive Administrative Director, Clinical Research Stanford Cancer Center
Contact — Cancer Center investigators should contact Miriam Bischoff, Executive Administrative Director, regarding new requests for assistance with study services.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard, published by the International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.
Good Clinical Practice guidelines include the protection of human rights, safety and welfare during clinical trials. They also assure clinical data integrity.
Good Clinical Practice guidelines include standards on how clinical trials should be conducted; and define the roles and responsibilities of clinical trial sponsors, clinical research investigators and monitors.
Education and Training
- Good Clinical Practice Fundamentals Course
This one-day course is designed for new clinical research coordinators, nurses and administrative staff, who have limited experience with and no formal training in Good Clinical Practices (GCP). It offers a comprehensive yet concentrated overview of the principles of GCP, FDA and Global Regulations, and the roles and responsibilities of the clinical investigator/site, IRB, sponsor, and study monitor. Emphasis is placed on the translation of GCP principles to the concepts of protocol adherence, informed consent process, good documentation practices, event reporting, and proactive preparation for FDA/Regulatory audits. Interactive exercises and case scenarios facilitate the application of these principles into everyday practice governing the conduct of clinical trials.
- GCP Beyond the Basics
For more experienced research coordinators, nurses and staff who are already familiar with basic GCP principles and are looking for more detail in areas of interest, four--hour sessions offer expanded instruction in selected GCP areas such as adverse event reporting, informed consent, and audit readiness.
- GCP Brown Bags
The Good Clinical Practice (GCP) Brown Bag sessions are informal monthly meetings open to anyone in the Stanford research community. Brown Bags offer a chance to meet people outside your department, to discuss topics of interest, ask questions and exchange solutions to common challenges. Past sessions have included discussions on working with non-English speakers, consenting participants over the phone and via mail, drug accountability, good documentation, recruitment, research with devices, and more.
- Meetings occur on the fourth Thursday of each month from 11:30 – 12:30pm. View the Spectrum Education Calendar for details and topics.
|Training Name or Topic||Faculty||Research Personnel||Postdocs|
|Collaborative IRB Training Initiative
|Environmental Health & Safety Training Assessment||REQUIRED||REQUIRED||REQUIRED|
|Training for Sponsor Investigator Research (SIR)||REQUIRED||Recommended*||Not Applicable|
|GCP Training through CITI||Recommended**||Recommended**||Recommended**|
|Budgeting & Billing Training||Recommended||REQUIRED***||Recommended|
|Health Screening, Safety & Compliance (HSSC) Program||Not Applicable||REQUIRED||Not Applicable|
|Orientation to Clinical Research at Stanford (General Orientation)||Optional||REQUIRED||Recommended|
|HealthStream for Postdoctoral Scholars (HS PostDoc) Program||Not Applicable||Not Applicable||REQUIRED|
* This training is a PI requirement, but research team members are strongly encouraged to attend at the same time. The training is not applicable to postdoctoral work, unless you are part of a study team conducting Sponsor Investigator Research (SIR).
** Required of Cancer Center personnel.
*** Required if involved in budgeting and billing; strongly recommended for personnel who enroll participants.
Required for non-faculty Stanford University School of Medicine clinical research personnel involved with human subject research and data (e.g., clinical trials). All employees are required to complete an HSSC Assessment form.
If it is determined job duties require participation in HSSC, participants will receive a packet including instructions to schedule an appointment for your health screening (if applicable), to complete safety and compliance training modules (required); how to register for General Orientation to Conducting Clinical Research at Stanford (required) and Budgeting and Billing Training (if applicable).
Click on the bold links below for more about this program.
HSSC is the Health Screening, Safety and Compliance (HSSC) Program at Stanford School of Medicine. The purpose of the HSSC Program is to:
- Protect the health and safety of the employees by preventing potentially infectious patients, human subjects, or clinical trial volunteers from exposing the employee, vice versa;
- Protect the employee from potential occupational exposures to biohazards in the workplace;
- Minimize institutional liability related to employees performing patient/study subject care duties within Stanford and its satellite facilities.
HSSC may require:
- R.N. License Verification
- Health Screening (Medical Surveillance)
- Safety and Compliance Training, including the HealthStream Learning Center annual training (due every August) and the orientation to Conducting Clinical Research at Stanford
HSSC is required for compliance with Joint Commission on Accreditation of Health Care Organizations (JCAHO) standards, Occupational Safety and Health Administration (OSHA) regulations, and other federal, state, and local regulations applicable to the licensing of hospital and clinical activities
School of Medicine Human Resource Group (HRG) responsibilities:
- Identifying employees who are assigned duties that require contact with patients and/or processing of patient samples.
- Compiling annual reports regarding compliance submitted to the Director of HRG, Senior Associate Dean for Finance & Administration, and the Senior Associate Dean for Research
Departments are responsible for:
- Notifying employees of requirements of the HSSC Program through the employment offer letter and orientation packet
- Verifying HSSC Assessment Form is true and complete
- Send completed HSSC Assessment Forms to Spectrum OTC
- Following up with employees who are non-compliant
Spectrum OTC is responsible for:
- Monitoring and tracking participation in the HSSC Program, and maintaining an employee database
- Coordinating with Stanford University Occupational Health Center (SUOHC) to ensure annual completion of the safety and compliance training and annual health screening
- Providing orientation to clinical trials research process and compliance
- Coordinating compliance training through learning modules at SHC/LPCH/SU/SoM
- Compiling annual reports regarding compliance submitted to the Director of HRG, Senior Associate Dean for Finance & Administration, and the Senior Associate Dean for Research
Employees are responsible for:
- Completing health-screening requirements with Stanford University Occupational Health Center
- Completing the appropriate safety and compliance training modules
- Completing the General Orientation, and Budgeting and Billing Training
The HSSC Assessment Form should be completed by Stanford University School of Medicine non-faculty staff involved in clinical (human subject) research studies.
- STAFF: Download and complete the HSSC Assessment Form and send to your Human Resources Manager (HRM). After verification your HRM will send the form to Spectrum OTC. The answers in this Assessment Form will determine your course assignments. You will receive a confirmation email with your required training and instructions.
If it is determined Health Screening is applicable, please schedule an appointment with SUOHC, complete and take with you all the required online forms:
- Health Screening Payment Authorization Form- includes instructions for initial and annual appointments, required form for SUOHC service.
- Gather all supporting medical and immunization records, as available.-Please provide a copy of your immunization records to SUOHC.
- Hepatitis B Declaration Form
- Tuberculosis Screening Questionnaire
For more information about Health Screening, please see “HSSC- Medical Surveillance (Health Screening)”
- Before accessing the safety and compliance modules through the HealthStream Learning Center, please make sure a HSSC Assessment Form is on file with Spectrum OTC. You will not be able to log-in until a profile is created for you.
- Log on to the Stanford School of Medicine HealthStream Learning Center (HLC).
- Enter your SU employee ID number as both User ID and password. (Your employee ID is the 8-digit ID number above your photo on your Stanford University ID card.) Upon successful login, your personal profile and required course modules will be displayed.
- Complete the modules assigned to you. Module titles that are followed by a "(PA)" indicate modules that can be passed with a pre-assessment quiz. To pass the quiz, you must complete it on the first try without interruption. If you stop short of completing the quiz, it will automatically be graded at that point making a "pass" unlikely.
HealthStream has minimum computer and browser requirements (Windows, IE 5.5 or higher; disable all popup blockers).
Orientation to Conducting Clinical Research at Stanford
Orientation to Conducting Clinical Research at Stanford (CTR General Orientation) is an informative introduction and review of the clinical research process at Stanford University. Designed for new clinical research personnel.
Required for all new SoM non-faculty clinical research employees. For additional information see “Orientation to Conducting Clinical Research at Stanford”.
Budgeting and Billing Training
Training provides a general overview of the clinical research budgeting and billing process. It includes the Clinical and Translational Research Planning (CTRP) Workbook process; billing procedures; and a review of the Medicare NCD policy.
Required if involved with budgeting and or billing of a research study. For more information see "Budgeting and Billing Training"
To register for either General Orientation or Budgeting and Billing Training, see Spectrum Training Calendar.
- The HSSC Assessment Form must be completed by all Stanford University School of Medicine non-faculty staff involved in clinical (human subject) research studies.
- If applicable, Spectrum OTC will send training instructions to SU employees.
- This program does not apply to faculty or postdoctoral scholars.
Spectrum OTC provides education, required training and professional growth opportunities to the Stanford clinical research community.
Whether new to Stanford or in need of a refresher course, the below list of training programs provides the information necessary to successfully conduct clinical research at Stanford.
REQUIRED TRAINING FOR CLINICAL RESEARCH PERSONNEL
- Collaborative IRB Training Initiative (CITI)* (Required)
Required human subjects training for all staff who work on research projects (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting). More »
- Orientation to Clinical Research at Stanford (General Orientation)
Required for new employees who are working in clinical research. At this orientation Spectrum OTC staff will meet with clinical research personnel to provide resources and tools to successfully navigate research studies at Stanford. More »
- Health Screening, Safety and Compliance (HSSC) Program
Required for all non-faculty Stanford School of Medicine clinical research personnel involved with human subject research and data (clinical trials). All employees must complete an HSSC Assessment Form. More »
- Budgeting and Billing Training
Required for all new and current employees who work on clinical research projects, if involved in budgeting and billing. Spectrum OTC offers monthly training sessions. More »
- Environmental Health and Safety Training Assessment
Everyone in the Stanford community is required to take some safety training. To clarify what safety training is necessary for each job function, Environmental Health and Safety developed the Training Assessment online tool for determining what safety training a SU employee needs to take. More »
- HIPAA Training
Stanford HIPAA training is required for every member of the workforce who comes into contact with Protected Health Information (PHI). More »
- eProtocol Training
eProtocol is an online application used at Stanford to submit, review, and approve research (human subjects; stem cells; animal subjects; and biosafety). More »
- GCP Training through CITI
If you are new to research or just need a refresher course, Good Clinical Practice (GCP) guidelines are available on-line through the IRB’s CITI training. More »
EDUCATION / WORKSHOPS
- Find a Workshop
View upcoming CTR educational workshops offered by Spectrum and affiliates, past presentations and videos, a list of courses, or request a workshop. More »
- Request a Workshop
View list of workshop topics, or suggest a topic. More »
OTHER TRAINING RESOURCES – STANFORD
- Lane Library
Lane Library’s instructional program supports clinical and bioresearch clientele with a class list that includes PowerPoint; Finding Funding; Basics of R Programming; Improving Your Scientific Writing Skills, and dozens more. More »
- Epic Training
Epic Training is required for all Stanford Hospital and Clinics physicians and medical personnel who need access to Hospital Medical Records.
Training is completed online. The specific courses that you are required to complete are dependent on your specialty, sub-specialty and scope of clinical practice. More »
- Cardinal Curriculum
Cardinal Curriculum is designed to develop Stanford's research administration workforce by providing tools for individuals to build competencies, increase efficiency, and improve compliance with Stanford and sponsor requirements. Training classes, which can lead to certification, are organized into two levels and are geared to individuals as they develop from novice to expert in research administration.
These classes will benefit research administrators and all administrative staff who support sponsored research.
- Cancer Clinical Trials Office (CCTO)
The CCTO provides training and quality assurance programs for both new and existing research staff to ensure that Cancer Institute research staff are current on all regulatory requirements as well as SCI standard operating procedures. More »
- Tech Training
Stanford University Information Technology Services (ITS) provides technology courses. See the ITS website for training options in the classroom, online, one-on-one by appointment, and custom classes. More »
The Stanford Training And Registration System (STARS) is Stanford's Learning Management System. Log in to Axess to see the STARS Training website which includes a “STARS Browse Catalog” and a “Training Needs Assessment” tool. More »
- Learning and Organizational Effectiveness
LOE Calendar of Course, Programs, and Conferences. More »
- Office of Sponsored Research (OSR)
The OSR website provides a list of recommended classes for those working with sponsored research. More »
PROFESSIONAL DEVELOPMENT RESOURCES – NON-STANFORD
ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. More »
- University of California Santa Cruz, Extension
The UCSC Extension Certificate in Clinical Trials Design and Management is designed to help professionals gain a solid understanding of the entire clinical trials process, as well as a foundation in the scientific principles, regulations, and ethics that are vitally important to the conduct of clinical research. More »
- San Francisco State University Extension
Through the Clinical Trial Design and Management Certificate Program students may complete a full certificate or simply take those courses which advance their own professional goals. The program is designed to be flexible for working adults by offering evening or weekend courses. More »
- University of California Berkeley Extension
UC Berkeley Extension offers a Certificate Program in Clinical Research Conduct and Management which enables you to master practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines, and ethical considerations. More »
- Some of this training is required before any research participants can be enrolled in a clinical study.
- You are responsible for maintaining training compliance for yourself, and if you are a PI, that of your research team.
Budgeting and Billing Training is required for all new and current employees working on clinical research projects, if involved in budgeting and billing (i.e. research coordinators enrolling study participants).
Training provides a general overview of the clinical research budgeting and billing process. It includes the Budgeting and Billing workbook process; billing procedures; and a review of the Medicare NCD policy.
This 2-hour training is offered monthly. Special training sessions are available for groups or departments upon request.
- Recommended for all research personnel who enroll study participants.
- Training is essential for successful and compliant billing.
In an effort to promote successful aging and end-of-life care for multicultural older adults, Stanford recently launched an Internet-based Successful Aging training program, called iSAGE. The mini-fellowship is funded with a grant from the National Institute on Minority Health Disparities, and it’s being offered for free to both health-care professionals and members of the public.
Multi-disciplinary health personnel (doctors, nurses, psychologists, social workers, chaplains, occupational therapists, massage therapists, physical therapists, marriage and family therapists and other allied health professionals) interested in learning about the scientific principles of successful aging and end of life care for multi-cultural older Americans should apply to become iSAGE mini-fellows.
It is anticipated that the entire mini-fellowship will take 80 hours of focused studying. These 80 hours can be completed over a three month period.