Conduct Study

OTC provides Study Facilitators who guide investigators and study personnel through the clinical research process, from study idea and design through close-out and publication, for clinical and translational research projects.

Study Facilitators are health professionals with extensive clinical research experience and expertise in navigating the Stanford clinical and translational research system. A Study Facilitator will advise you and consult appropriate experts regarding:

Getting Started

• Do I need help with my study design?
• What is a Case Report Form and how do I create one?
• Can I do my study at Stanford?
• What resources are available to support my project?

Regulatory Requirements

• What are FDA requirements?
• Do I need IRB approval?
• Do I need an IND or IDE for my research project?
• What does it mean to be a Sponsor-Investigator?
• What documents are essential for my research?

Budget and Billing Matters

• What is RMG and who is my RPM?
• What is Medicare Pre-authorization?
• How do I get started with my budget?
• Who do I contact for billing issues?
• What is the workbook?

Staffing Needs

• Do I need a coordinator?
• What does a coordinator do?
• How much will a coordinator cost?

Grant and Contract Processes

• When do I need a contract?
• What is the Office of Sponsored Research (OSR) and who is my contract officer?
• How do I finance my study?
• Do I need a contract if I am getting equipment on loan?
• Who do I contact about my grant?

Research Budgeting & Billing Support

• Research Management Group (RMG) provides study budgeting support. Contact your RPM for general clinical research budgeting, pricing and process questions.
• The Cancer Clinical Trials Office (CCTO) provides study budgeting support for cancer/oncology clinical research.
• Spectrum OTC provides budget and billing training.

Key Points

• Know your protocol before you contact your RPM.
• Be prepared to discuss your budgeting requirements.

Stanford Hospital and Clinics

• Patient Financial Services (PFS) provides research participant billing support for services provided at the hospital and in the clinics.
• Physician Services Organization (PSO) provides research participant billing support for professional fees.

Lucile Packard Children's Hospital (LPCH)

• Patient Financial Services (PFS) provides research participant billing support for services provided at the hospital and in the clinics.
• Physician Services Organization (PSO) provides research participant billing support for professional fees.

CTRU

• The CTRU Financial Manager provides research participant billing support for services provided at the CTRU.

Key Points

• Keep an accurate, complete, up-to-date workbook (including enrollment status).
• Review and return billing reports in a timely manner.

If you need access to electronic medical records for research purposes you should use STRIDE.

If you need access to electronic medical records and ancillary data for your cancer research project, contact Stanford Cancer Institute Research Database (SCIRDB).

What is an Electronic Medical Record (EMR)?

An Electronic Medical Record (EMR) is a systematic collection of electronic health information about individual patients or populations. Records may include a whole range of data in comprehensive or summary form, including demographics, medical history, medication and allergies, immunization status, laboratory test results, radiology images, vital signs, personal stats like age and weight, and billing information.

• Stanford Hospital and Clinics (SHC) uses Epic
• Lucile Packard Children's Hospital (LPCH) uses Epic

Epic (for SHC Electronic Medical Records)

What is Epic?

How to Get Access to Epic

Is Epic Part 11 Compliant?

SHC Epic-Support

Do I need IRB approval to review Electronic Medical Records?

How do I get a printout of the medical record from Stanford Hospital?

How do I contact the Medical Record Department?

Epic (for LPCH Electronic Medical Records)

LPCH Epic Access

LPCH Epic – Support

21 Part 11 Compliance Document

How do I get a copy of the medical records from Epic for LPCH?

The Ethics Committee of the Stanford Hospital and Clinics provides a medical ethics consult service for the hospital and clinics. Anyone may request a consult.

Ethics consults usually involve a situation where patient care is impacted by conflicts in values between and/or among patients, families, and treatment providers.

Ethics consults consist of a process whereby facts are gathered from all relevant persons, values are elucidated and prioritized, and recommendations made so as to honor as much as possible the priority of values.

Who can use the consultation service?

Anyone, including

• patients or their families
• nurses
• allied health care professionals
• staff
• physicians

Who staffs the consultation service?

In most cases, ethics consults involve a multidisciplinary team of persons from the ethics committee led by a member trained and/or experienced in medical ethics theory and consult management.

Is a consultation confidential?

Yes; the identities of those requesting consultations and all data, ideas and ethical issues are confidential. With permission of the parties involved, de-identified descriptions of cases may be requested for educational purposes.

What are some examples of situations that may need an ethics consultation?

The issues involved in ethics consultations have included such matters as

• differences of opinion about whether to stop aggressive end-of-life treatment and switch a patient to palliative care only
• whether psychiatric patients can refuse surgery or medical treatment
• uncertainty about who can best serve as surrogate decision maker for an unconscious patient
• disagreements among family members about the treatment choices for an incompetent patient
• demands for treatment that  are considered futile by physicians
• doubts about what treatments are in the best interests of the patient
• uncertainty about treatment choices that are based on religious or cultural imperatives
• the extent to which non-medical facts and circumstances impact a decision to offer organ transplant for a particular patients
• whether a patient is being made to suffer unnecessarily by reducing or withdrawing pain medication
• how to best protect a patient from the harmful acts of a close family member

The Benchside Ethics Consultation Service (BECS) assists investigators with ethical issues in the design of conduct of a study. For example, a consultation could help with:

• analyzing the impacts of a particular policy on the conduct of bench science.
• identifying the ethical or social impacts of conducting a particular line of research.
• suggesting specific actions to minimize risks and maximize benefits to society of pursuing that line of research.

The program allows for proactive identification of important ethical and policy issues in biomedical research. Through early and direct interactions among ethicists, philosophers, social scientists, lawyers, biomedical scientists and others, BECS aims to facilitate discussions with researchers about as-yet-undefined, cutting-edge science as it unfolds.

Stanford University faculty and members of the Stanford Center for Biomedical Ethics staff the service. They are experts in research ethics and regulation, and they represent a wide range of disciplines including biomedical research, genetics, law and philosophy.

Who can use the consultation service?

Any member of the Stanford University community, including:

• Research investigators (the PI or anyone on the research team), study participants, coordinators
• Stanford faculty, staff, scholars, students and medical professionals
• Institutional Review Boards
• Regulatory committees and other institutional bodies

Confidentiality

The identities of those requesting consultations and all research data, ideas and ethical issues are confidential. With permission of the investigators, de-identified descriptions of cases may be requested for educational purposes.

Scope and limitations of the consultation service

Requests that fall under the direct regulation and/or recommendation of another institutional body (such as the FDA, IRB, University Conflict of Interest Committee or OMBUDS offices) will be referred to the appropriate group for further consideration. For example, the consultation service is not meant to supersede the IRB or adjudicate cases of scientific misconduct.

For particularly complex or involved requests, the consultation team may solicit the advice and guidance of an outside group.

Not all cases can or will be dealt with collaboratively; it will depend on the scope and breadth of a particular request and what is reasonably agreed upon by the consultation team and the researchers calling the consultation.

Kinds of research that would be recommended for an ethics consultation

Anyone can request an ethics consultation to get answers to ethical, social, or legal issues that they think might be related to the conduct or implications of their research. The service is not designed to replace the Human Subjects Panel, the Stem Cell Research Oversight Committee, or any other institutional or regulatory body. Some categories of biomedical research raise issues about which there is no clear policy or ethical consensus or that are not addressed by existing regulations.

Examples include:

• Research that could generate incidental findings
• Research that could generate findings of clinical significance to individual research participants
• Tissue/DNA banking
• Research in less developed countries
• Community engagement in research
• Stem cell research
• Pediatric research that is likely to pose more than minimal risk
• Research on identified racial/ethnic groups, and/or indigenous peoples
• Research that is not broadly socially accepted

How consultations are supported

BECS was established as part of CIRGE with a grant from the National Institutes of Health (NIH) and the US Department of Energy (DOE). It is also supported by Spectrum, which is funded, in part, by the NIH Clinical and Translational Science Award.

The Research Personnel Advisory Committee is a group of experienced research coordinators who meet monthly to exchange ideas and advice on various selected topics concerning current clinical research processes and events at Stanford University.

RPAC's mission is to:

• Represent SoM Research Personnel interests, concerns and opportunities
• Participate in identifying "areas of impact" for change and or advancement of clinical research activities
• Serve as Research Personnel sounding board for new and innovative program offerings by Spectrum
• Give feedback regarding opportunities for synergy across the Stanford community
• Help disseminate research updates and information back to the department

The Research Personnel Advisory Committee is a Spectrum led group. We are currently seeking nominations for new members from underrepresented research areas.

Contact Anna Hu if you know of someone who would be interested in participating in this committee.

• Stanford Human Research Protection Policy (HRPP)


• Research Policy Handbook (RPH)
  


• Human Subjects Research Guidances

• Payment: Ethical Considerations
• Payment: Stanford University Job Aid: Paying Human Subjects


• Medicare IDE Preauthorization Packet
  • Quick Guide
  • Checklist
  • Cover Letter
  
  

• What is a qualifying clinical trial? (pdf)
• Does a procedure or service qualify for routine care cost coverage? (pdf)


• Categorization of Investigational Devices Coverage Under Medicare (pdf, 2/28/96)


• Investigational New Drug (IND)


• Investigational Device (IDE)

Regulatory and Compliance support services provided by OTC include:

• FDA audit preparation and facilitation
• Sponsor audit preparation and assistance when requested
• Support for IND and IDE submissions
• Good Clinical Practice support and study review
• Regulatory Binder preparation and compliance review
• Consultation for any regulatory or compliance question, whether FDA, OHRP, or ICH/GCP.
• Support for billing compliance questions, liaison with hospital billing and risk management
• Study document management: storage/archiving coordination and contract services
• Liaison services for complex regulatory or compliance questions between RMG, OSR and the IRB
• Liaison to Stanford Hospital and Clinics (SHC) and Lucile Packard Children’s Hospital (LPCH) compliance department

QuickLinks

• Research Compliance Office
• Administrative Panels on Human Subjects in Medical Research (Institutional Review Board)
• Dean of Research
• Research Policy Handbook (RPH)
• HIPAA
• ClinicalTrials.gov

• 21 CFR Part 11 compliance documentation available upon request  .

• Laboratory CLIA/CAP certificates


• Document Management and Storage
  Document management and storage with Iron Mountain – Contact Linda Walker  , or call (650) 498-6498.


• Download Sample (IND)
  Sample Regulatory Binder Table of Contents for IND studies (.pdf, rev. 07/22/10)


• Download Sample (IDE)
  Sample Regulatory Binder Table of Contents for IDE studies (.pdf, rev. 07/22/10)


• Medicare IDE Preauthorization Packet
  • Quick Guide
  • Checklist
  • Cover Letter
  
  

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.

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.

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

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.

The National Institutes of Health, through its Office of Clinical Research Training and Medical Education, offers several courses for online training in the area of clinical research.

Introduction to the Principles and Practice of Clinical Research

This is a course on how to effectively conduct clinical research, formalizing instruction that is normally taught through mentorship. The recommended textbook is Principles and Practice of Clinical Research, second edition (2007), edited by John I. Gallin and Frederick P. Ognibene and published by Academic Press/Elsevier (Lane Library | Amazon).
» Course information and application.

Principles of Clinical Pharmacology

This course consists of a weekly lecture series covering the fundamentals of clinical pharmacology as a translational scientific discipline focused on rational drug development and utilization in therapeutics. The recommended textbook is Principles of Clinical Pharmacology, Second Edition (2007) edited by Arthur J. Atkinson, Jr., et al. and published by Academic Press/Elsevier (Amazon). This complements the material covered in the “Introduction to the Principles and Practice of Clinical Research.”

This course was designed to assist individuals who are preparing to take the certifying examinations of the American Board of Clinical Pharmacology and to meet the needs of researchers with an interest in the clinical pharmacologic aspects of contemporary drug development and utilization.
» Course information and application.

Clinical Research Training Online Course for Principal Investigators

This course addresses one of the essential standards approved by the NIH for performing clinical research in the Intramural Research Program. This material is also covered by the "Introduction to the Principles and Practice of Clinical Research" and "Ethical and Regulatory Aspects of Human Subjects Research" courses.
» Course information and application.

Ethical and Regulatory Aspects of Clinical Research

This course is offered to anyone interested or involved in clinical research involving human subjects.
» Course information and registration.

Spectrum mentoring efforts are intended to 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 a Council of Mentors for junior investigators.

The Health Insurance Portability and Accountability Act (HIPAA) – Each person at Stanford University who is part of the Stanford University HIPAA Components workforce must be aware of the obligations imposed by HIPAA and the Privacy and Security Rules.

To understand your responsibility, read the policies and procedures for compliance and training at Stanford University HIPAA: Health Information, Privacy and Security Information.

Key Points

• Stanford HIPAA training is required for every member of the workforce who comes in contact with PHI.
• Your department will determine the HIPAA training modules that you are required to complete.

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.

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 goal of ResearchMatch is to bring together people who are trying to find research studies, and researchers who are looking for people to participate in their studies. Many studies are looking for healthy people of all ages, while some are looking for people with specific health conditions.

The ResearchMatch registry is free and secure, and anyone can join.

ResearchMatch is a Clinical and Translational Science Awards (CTSA) initiative funded by the National Center for Research Resources, a part of the NIH.

TRAM, the Translational Research and Applied Medicine Program, is dedicated to fostering interactions between physicians and scientists that translate bench-side discoveries into the clinic.

It was established to provide an infrastructure to rapidly translate novel genomic/proteomic, nanoscale and imaging research discoveries from the laboratory to the clinic and facilitate bench-to-bedside development of cellular therapies.

TRAM helps to support diverse translational research projects that will result in innovative approaches to the prevention, early detection, diagnosis and treatment of human cancers, heart disease, HIV infection, myelofibrosis, systemic sclerosis, graft-versus-host, as well as other human diseases.