Staff Training

The Orientation to Conducting Clinical Research at Stanford (CTR General Orientation) is a two-hour introduction and review of the clinical research process at Stanford University, designed for new clinical research personnel.

Orientation Objectives:

• 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)

Key Points

• Orientation assists new clinical research personnel in navigating 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. Training is required every three years (two years for VA).

Key Points

• 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.

Key Points

• 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.

Website — Cancer Clinical Trials Office

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.

Useful Links

• ICH E6: Good Clinical Practice: Consolidated Guidance
• FDA Office of Good Clinical Practice
• FDA Clinical Trials
• International Conference of Harmonization (at FDA)

Education and Training

Stanford Courses

• Collaborative IRB Training Initiative (CITI)
  The CITI trainings offered through the Research Compliance Office include modules in good clinical practice. These modules offer a general overview and are free of charge.
• For more information about CITI training, see the Research Compliance Office website.

• 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.

This applies if you are a SoM (non-faculty) employee or postdoc who: 1) may be assigned duties with potential for occupational health exposures related to clinical research participants and 2) performs job duties (including Epic access) within SHC, LPCH, and/or other Stanford affiliated research patient care locations. For staff who will participate in any clinical trials/research study, you are required to complete health screening, safety and compliance training administered by Environmental Health & Safety (EH&S) and Stanford University Medical Center (SUMC) HealthStream.

School of Medicine Clinical Research Staff and PostDocs are responsible for:

• Completing health-screening requirements with Stanford University Occupational Health Center
• Completing the appropriate safety and compliance training with Environmental Health & Safety AND online modules with SUMC HealthStream
• Completing the General Orientation, and Budgeting and Billing Training

EH&S/Occ Health Fee Schedule

HealthStream Orientation Document

HealthStream FAQs

Register for Spectrum Training

Memos, Updates, and Reminders

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 Training
  Required for all non-faculty Stanford School of Medicine clinical research personnel (and postdocs) involved with human subject research. Supervisor to complete Clinical Researchers Occupational Exposures Assessment Questionnaire on new employee/postdoc's behalf.

  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 »

RECOMMENDED TRAINING

• 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.
  More »

• 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 »
• STARS
  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
  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 »

Key Points

• 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.

Key Points

• Recommended for all research personnel who enroll study participants.

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.