Research Education & Training

One of the most effective ways to increase and sustain the “pipeline” of translational and clinical research scientists is to stimulate interest in careers in the biological sciences and medicine early in life. For this reason, it is vital to offer meaningful exposures to the life sciences to high school students. Supporting programs for minority and low-income students is an especially critical pipeline issue.

Stanford provides several opportunities for high school students to gain exposure to clinical and translational research, iincluding the following:

• Outreach Programs
• Stanford at the Tech
• Stanford Institutes of Medicine Summer Research Program
• Stanford Medical Youth Science Program

To increase the number of students in the “pipeline” of clinical and translational researchers, Spectrum encourages participation of undergraduates in clinical and translational research and related training opportunities. This is accomplished primarily through two programs at Stanford:

• Undergraduate Academic Life Program (Research Opportunities)
• Freshman and Sophomore Introductory Seminars

Spectrum supports the training of basic science graduate students in the area of clinical medicine to enable them to become clinical and translational researchers. This is accomplished through three master's degree programs that are available to qualified PhD graduate students.

• Masters of Medicine
• Masters in Epidemiology and Clinical Research
• Masters in Health Services Research

Spectrum directly supports students pursuing a master’s degree in either Epidemiology or Health Services Research, through the K and T Awards, to provide the training and skills for conducting clinical and translational research.

The top applicants to the Masters Programs are selected for tuition and stipend support and appointed as Spectrum scholars and trainees.

The following programs support training in the conduct of clinical and translational research:

• Scholarly Concentrations
• Masters in Epidemiology and Clinical Research
• Masters in Health Services Research

Several programs support postdoctoral fellows and scholars to further their training and career development in the area of clinical and translational research. Among the education and training opportunities are:

• Advanced Residency Training at Stanford (ARTS)
• Biodesign Fellowship
• Masters in Epidemiology and Clinical Research
• Masters in Health Services Research

Spectrum develops and supports research and training programs for residents interested in acquiring or maintaining the requisite critical skills contributing to their continued career development as skilled clinician scientists.

Spectrum fosters resident interest in CTR through several programs:

• Masters in Epidemiology and Clinical Research
• Intensive Course in Clinical Research
• CTR Training in Residency
• Stanford Society of Physician Scholars (SSPS)

Junior Faculty are welcome to apply for the K Award to receive a

• Masters in Epidemiology and Clinical Research, or
• Masters in Health Services Research

Junior faculty are also encouraged to consider participating in the 5-day Intensive Course in Clinical Research (ICCR).

Spectrum provides mentoring support. Currently, the Pediatrics Mentoring Program is available for assistant professors and instructors to support career development in clinical and translational research.

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 FACULTY

• 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 »
• 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 »
• Training for Sponsor Investigator Research (SIR)
  Required for investigators who intend to obtain their own Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications from FDA.  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 »
• 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 »
• 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 »

EDUCATION / WORKSHOPS

• ICCR – Intensive Course in Clinical Research: Study Design and Performance
  The Intensive Course in Clinical Research (ICCR) is a one-week immersion course developed at Stanford for new clinical investigators, senior residents, fellows and junior faculty, interested in pursuing careers in clinical and translational research. More »
• 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 »

MENTORING

• Mentoring Support for Junior Investigators
  Child Health junior investigators can participate in the mentoring program conducted by Spectrum Child Health. Expansion of this program for additional investigators is underway.  More »

OTHER TRAINING RESOURCES – STANFORD

• Spectrum Child Health
  Spectrum Child Health offers a centralized clinical core with research support personnel, assistance with scientific expertise and advice, and career development training for junior investigators. 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 »
• 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 »
• 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 Development
  Information and awareness of resources for courses, programs, and conferences useful to any staff member for professional development.  More »
• Leadership Training
  The Office of Diversity and Leadership provides several programs that enable faculty to build and develop leadership skills.  More »
• Cancer Clinical Trials Office (CCTO)
  The Cancer Clinical Trials Office provides regulatory, administrative, research, and educational services to Cancer Center investigators conducting clinical trials.  More »
• Office of Sponsored Research (OSR)
  Provides pre- and post-award administration of sponsored projects to the University.  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.

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.

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 »
• 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 »
• 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 »

EDUCATION / WORKSHOPS

• ICCR – Intensive Course in Clinical Research: Study Design and Performance
  The Intensive Course in Clinical Research (ICCR) is a one-week immersion course developed at Stanford for new clinical investigators, senior residents, fellows and junior faculty, interested in pursuing careers in clinical and translational research. More »
• 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

• Spectrum Child Health
  
  • Pediatrics Mentoring Program
    The Pediatrics Mentoring Program is dedicated to the academic enrichment and success of early career investigators in the Department of Pediatrics. More »
  • ICCR – Intensive Course in Clinical Research: Study Design and Performance
    The Intensive Course in Clinical Research (ICCR) is a one-week immersion course developed at Stanford for new clinical investigators, senior residents, fellows and junior faculty, interested in pursuing careers in clinical and translational research. More »
• 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 »
• 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.
• Most training required for postdocs is managed by your department administrator

Spectrum mentoring efforts support the career development of junior investigators and other trainees. Spectrum Child Health has a well-developed mentoring program for child health investigators.

Additional efforts are in early development stages, and ultimately will include:

• Council of Mentors for junior investigators
• Mentor matching for potential trainees (to be developed through the Community Academic Profile)
• Searchable trainee database to enable greater understanding of existing trainee efforts and allow for trainee networking opportunities (to be developed through the Community Academic Profile)

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.

The Spectrum KL2/TL1 Training Awards are career mentored training awards for junior faculty, fellows, residents, medical and doctoral students providing both tuition and salary support with an emphasis on education and training in clinical and translational research.

Spectrum's goal in the area of education is to create a fully integrated, University-wide, clinical and translational research community that stimulates and educates all levels of trainees interested in investigational careers focused on human health.

Programs supported by Spectrum target the continuum of trainees from the high school level through junior faculty.