Stanford

Operations, Training and Compliance

OTC

Spectrum serves faculty and clinical research personnel at Stanford School of Medicine, Stanford University Medical Center, Lucile Packard Children's Hospital, and the Veterans Affairs Palo Alto Health Care System.

Services Provided
  • Budget & Billing Support
  • Regulatory/Compliance Support
  • Training & Education
  • Point of Contact for questions about clinical research

OnCore CTMS for
Non-Cancer Studies

» Resources & Links
» OnCore Login


Contact Information

Spectrum
Operations, Training & Compliance
800 Welch Road
MC: 5737
Palo Alto, CA 94304
Fax (650) 723-8552


Spectrum OTC provides information and can assist you in these areas:

1.  Budgeting & Billing
2.  Clinical Trials Information
3.  Resources
4.  Guidance for Electronic Medical Records
5.  Publishing Requirements
6.  Regulatory & Compliance

Also see the TRAINING & MENTORING tab above on this page.

Overview - OTC Services

Operations, Training and Compliance (OTC) is a part of Spectrum, the Stanford Center for Clinical and Translational Research and Education.

OTC serves faculty and clinical research personnel at the Stanford School of Medicine, Stanford University Medical Center, Lucile Packard Children's Hospital (LPCH), and the Veterans Affairs Palo Alto Health Care System (VAPAHCS). OTC also serves as a liaison regarding clinical and translational resources with the community at large.

OTC staff provide support for a variety of clinical study matters, in areas such as budgeting and billing, compliance and regulatory services, training, and study facilitation.

Study Facilitators will answer your questions about conducting clinical research at Stanford and can guide you through the process.

Learn more about the roles and services offered by OTC by opening the headers below.

Arrow Icon OTC Roles

Arrow Icon Overview of OTC Services

Arrow Icon Study Facilitator Services

Arrow Icon Budgeting and Billing Support

Arrow Icon Regulatory and Compliance Support

Arrow Icon Education and Training Opportunities

Arrow Icon Community Research Inquiries

Planning research - Items to consider

The clinical research process for clinical and translational research projects, from study idea and design through close-out and publication, requires consideration and often consultation with 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?

Overview of Budgeting & Billing

Request Support for Research Participant Billing

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.

Next Steps

Request Support for Research Budgets

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.

Next Steps

Start the Budget and Billing Process

Download SHC Forms

Download LPCH Forms

SHC & LPCH Codes and Research Pricing Information

Clinical Research Quality

Clinical Research Quality facilitates clinical research regulatory compliance by developing operating procedures, policies, and best practices within the School of Medicine; tracking FDA, GCP, and ClincalTrials.gov compliance; educating and training researchers, faculty, trainees, and staff; conducting quality reviews and assisting with corrective and preventive action when needed. CRQ collaborates with Stanford University SoM departments, institutes and centers, as needed, with the Research Compliance Office, and internal audit offices.

Clinical Research Quality program

  • This program, currently being developed, will provide:
      • Quality audits of clinical research
      • Assistance with corrective and preventive action (CAPA) plans
      • Standard Operating Procedure (SOP) and Best Practice guidance
      • Training

  • Contact Clinical Research Quality  email to:
      • Request a quality audit
      • Suggest an SOP
      • Request best practice guidance
      • Request CAPA assistance
      • Request consultation prior to regulatory audit (FDA, external, sponsor)

Clinical Trials Disclosure (ClinicalTrials.gov)

    • Access to Stanford's Protocol Registration System (PRS)
    • ClinicalTrials.gov registration information and support
    • Biostatistics referrals for protocol development or results reporting support
    • News
    • Literature
    • Training

Clinical Research - Protocol Templates and Guidance


  • ClinicalTrials.gov questions?

  • Clinical Trials Disclosure (ClinicalTrials.gov)

    Match Investigators to Sponsors

    Spectrum Operations, Training and Compliance (OTC) is a multi-disciplinary service organization at Stanford. Spectrum OTC is a single point of contact for industry sponsors which provides:

    • Information/communication about clinical research at Stanford
    • Identify faculty with particular research expertise and interests
    • Identify potential principal investigators for clinical research
    • Obtain general information about clinical research activities, research capabilities, facilities and sponsored research administration
    • Streamline communications among sponsor, research administrators, PI and research personnel
    Next Steps

    Are you interested in Stanford as a potential site for your clinical trial?

    Match Potential Participants to Research Studies

    Spectrum Operations, Training and Compliance (OTC) is a multi-disciplinary service organization at Stanford.

    OTC is a single point of contact for potential research participants which provides:

    • information and communication about clinical research at Stanford
    • assistance in identifying clinical trials which may be enrolling
    • assistance in locating other resources for finding open clinical trials

    Next Steps

    Interested in participating in a research study at Stanford?

    Research Personnel Advisory Committee (RPAC)

    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.

    Next Steps
    • RPAC Membership list (coming soon!)
    • More Information
      Contact the RPAC chair, Anna Hu, (650) 498-7921.

    Staff Your Clinical Research Study

    An essential step in clinical research, after you've secured funding and established the parameters of your project, is organizing a staff that will enable you to conduct the study. If you're already working in a clinical setting, you'll most likely have a staff of health care professionals and administrators to assist you with patients. However, if you don't have access to these resources, you'll need to carefully consider your staffing needs. The first step is to determine the type of staff you need.

    What does a Research Coordinator do?

    The duties of a research coordinator may include:

    • Serve as a liaison between the sponsor/CRO, PI, patients and IRB
    • Submit regulatory documents, revisions and renewals to the IRB
    • Advertise for, screen, consent, enroll, and randomize patients
    • Schedule patient visits and tests
    • Conduct study visits with patients
    • Track and document adverse events
    • Compile source documents
    • Fill out required logs and case report forms
    • Follow GCP (good clinical practices) and ICH (International Conference on Harmonization) guidelines for research on human subjects
    • Communicate effectively with the study team to address queries
    • Attend investigator meetings and coordinate monitoring visits

    Do you need a registered nurse?

    For many clinical studies, having an RN on staff is essential because you'll need someone with a solid health care background who can perform some medical procedures. If your research project involves an experimental drug or medical device, you'll need someone who can watch for possible adverse events and who is knowledgeable about the risks and benefits to the study participants. You'll also need someone who can communicate effectively with participants and be able to explain or discuss the nature of the study with someone who doesn't have a medical background.

    In some cases, a licensed practical nurse, someone with medical training, or someone with research experience might suffice, but to independently monitor and assess study participants, you'll need a research nurse.

    Do you need a research coordinator or data manager?

    A research coordinator or a data manager can be very helpful additions to your staff. While a data manager can assist in maintaining data records and ensuring continuity in data collection, a research coordinator can provide valuable assistance in recruiting and screening study participants or in carrying out certain elements of the research project. Research coordinators can also help with management of the Regulatory Binder and consenting of patients for less medically complex protocols. Some research coordinators have phlebotomy certificates which allows them to help with blood draws if needed.

    Are there special staffing considerations for a very large project?

    If you're conducting a large clinical research project or find yourself in an especially large clinical setting, you might want to hire staff members specifically to handle regulatory work and clinical coordination. Ensuring that your study is compliant with FDA regulations throughout the project and that IRB submissions are handled properly and on-time can be demanding, especially in the case of a large study; having a person designated to handle such tasks can be a major benefit. This may mean you need a research nurse, a research coordinator and a data manager.

    Decision tree to help investigators in hiring research staff

    Investigators are responsible for protecting the rights, safety, and welfare of subjects under their care during a clinical trial (21 CFR 312.60 and 812.100).

    The following skills are necessary to help you with your protocol management depending on the complexity of your research protocol and subjects. These will ensure that your study is managed effectively with emphasis on the safety and follow up of your subjects as well as managing the protocol to the highest standard per ICH and GCP guidelines.

    • Critical Decision Skills
      • Protocol Management
      • Subject Safety
      • AE management
    • Knowledge Base
      • Recruitment
      • Consenting
      • Education
    • Assessment
      • Screening
      • AE management
      • Subject follow up
    • Extraction and Analyzation and Interpretation of Information/Data
      • AE reporting
      • Management of abnormal values, etc.
      • Source documentation and CRF completion

    To help you determine what experience and training your coordinator should have, it is important that you have an understanding of the protocol. The following subject headings will provide you with some guidance to determine the level of complexity that is required based on your subject population and what is being studied.

    • Protocol Complexity
      • Is the Protocol an IND or IDE?
      • Will subjects be consented during routine clinic visits?
      • Does the protocol require multiple follow up visits?
      • Will there be an outside resource used for study related procedures
      • Are there any procedures that require a licensed nurse?
      • Do the follow up clinic visits require interventions, i.e. vital signs, wound care, lab draws, and study medication administration?
      • Are there multiple protocol related procedures, i.e. labs, EKG, radiology etc
    • Subject Population
      • Healthy volunteers
      • Rare disease
      • Multiple co-morbidities
      • Newly diagnosed disease process
      • Are these subjects with existing chronic illnesses?
      • Are these subjects enrolled in a critical care setting, i.e. ICU/ED
      • What is the emotional status of subject during recruitment and consent process?
      • Age of subject

    Location for Study Conduct

    • Subjects residence
    • Clinic or outpatient Dept
    • Clinical Research Unit (CTRU)
    • CRC or PI office
      • In patient unit
      • ICU
      • ER
      • Medical or Surgical floor
      • Step down monitored unit

    Coordination

    • Will screening and followup require communication with:
      • multiple clinicians and other health care providers
      • Outside services and providers
      • Other departments related to clinical care
      • Other departments within institution related to research administration
      • Multiple sponsor related services, i.e. IVRS, Coordinating Center, CRO, etc.

    Education and Communication

    • Will the protocol require other health care providers to receive education/in-service?
    • Will the subject require subject education for compliance of protocol
    • Same list as above under Coordination

    Resources for Finding a Coordinator

    Spectrum has an email list of experienced university staff interested in part-time and full-time work. If you have a job posting that you would like us to distribute to our email list please contact Spectrum OTC.

    Resources for Child Health

    Spectrum Child Health offers coordinator and nursing services for child health studies. Please e-mail Mary Chen or phone 736-9783 for more information.

    Jobs

    Spectrum periodically circulates information about new openings in clinical research to a self-identified pool of external job-seekers, as well as to our internal research coordinator pool.  From time to time, Spectrum is contacted by faculty and department administrators to distribute open clinical research employment opportunities to our database.

    Subscribe to the Spectrum OTC email list

    If you would like to be added to our e-mail list, please send your information to: Spectrum OTC  email This is an informal service, intended only to be a supplement to the official University job posting process through the Stanford University Human Resources Office.


    Next Steps

    Electronic Medical Records

    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)

    Arrow Icon What is Epic?

    Arrow Icon How to Get Access to Epic

    Arrow Icon Is Epic Part 11 Compliant?

    Arrow Icon SHC Epic-Support

    Arrow Icon Do I need IRB approval to review Electronic Medical Records?

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

    Arrow Icon How do I contact the Medical Record Department?

    Epic (for LPCH Electronic Medical Records)

    Arrow Icon LPCH Epic Access

    Arrow Icon LPCH Epic – Support

    Arrow Icon 21 Part 11 Compliance Document

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

    Acknowledge Grant Support — Wording for Manuscripts

    Comply with NIH Public Access Policy

    REQUIREMENT!

    All publications resulting from the utilization of any Spectrum resource or service must be compliant with the NIH Public Access Policy.

    The following is excerpted from the National Institutes of Health Public Access website:
    “The NIH Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.”

    The PMCID is unique reference number that is assigned to each article that is accepted into PubMed Central.


    Next Steps

    Submit Manuscript to PubMed Central & Report PMCID

    REQUIREMENT!

    Each publication, press release, or other document that cites the results from NIH grant-supported research must be submitted to PubMed Central, and the PMCID number must be reported.

    The PMCID is a unique reference number assigned to each article accepted into PubMed Central.

    For more information about this requirement, see the NIH website regarding public access.

    Next Steps

    Regulatory & Compliance — Support Services, Resources and QuickLinks

    Conflict of Interest Policy and Information

    Stanford faculty members owe their primary professional allegiance to the University, and their primary commitment of time and intellectual energies should be to the education, research, and scholarship programs of the institution.

    Faculty members should conduct their affairs so as to avoid conflicts of commitment and avoid or minimize conflicts of interest. Disclosure of such interests is required under University, as well as School of Medicine policy.

    Find important information you need to know about conflict of interest (COI) on the School of Medicine Conflict of Interest website:

    • Policies
    • Stanford Industry Interactions Policy
    • Annual Outside Professional Activities Certification
    • Ad-hoc Disclosure Procedures
    • Tips for Avoiding Conflicts of Commitment & Interest
    Key Points
    • Disclosure of conflicts of commitment and interests is REQUIRED under University, as well as School of Medicine policy.

    Next Steps

    Documentation



    Next Steps

    FDA Submissions – Devices (IDE)

    The U.S. Food and Drug Administration website provides information for regulated industry on determining how to comply with the federal laws and regulations governing medical devices. See their Device Advice: Device Regulation and Guidance page for the following information and more:

    • Overview of Medical Device Regulation
    • Compliance Activities (Medical Devices)
    • Postmarket Requirements
    • Standards

    Training

    Spectrum works in collaboration with the IRB and the Cancer Clinical Trials Office to provide education and training for investigators and research teams conducting research with INDs and IDEs held by a Stanford investigator.

    Next Steps

    FDA Submissions – Drugs & Biologics (IND)

    The U.S. Food and Drug Administration website provides information for the Investigational New Drug (IND) Application. The site includes information and resources including:

    • Pre-IND Consultation Program
    • Guidance Documents for INDs
    • Laws, Regulations, Policies and Procedures
    • Emergency Use of an Investigational Drug or Biologic
    • Related Resources, including Applications

    Training

    Spectrum works in collaboration with the IRB and the Cancer Clinical Trials Office to provide education and training for investigators and research teams conducting research with INDs and IDEs held by a Stanford investigator.

    Next Steps

    Policies & Standard Operating Procedures

    Next Steps

    Mentoring Support for Junior Investigators

    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.

    Next Steps

    Budgeting & Billing Training

    Research Billing Training

    Research Billing Training is required for all employees involved in the management of research participants in human subjects’ research projects that will include services provided by either of the Stanford Hospitals or any of its clinics. (ie. enrolling subjects, scheduling subject visits.)

    This course provides an overview of the Stanford research billing process, including a review of the Budgeting and Billing workbook. Participants learn how to set up a study account with each of the Stanford Hospitals as well as identifying strategies to ensure research billing compliance.



    Research Budgeting Training

    Research Budgeting Training is required for all employees involved in budgeting human subjects’ research projects that will include services provided by either of the Stanford Hospitals or any of its clinics.

    This course introduces the Research Management Group (RMG) process and reviews the study team’s responsibilities. There is also a demonstration on how to complete the Budgeting and Billing workbook.



    Key Points
    • Recommended for all research personnel who enroll study participants.
    • To complete this training, please sign-in, complete the quiz and the evaluation.

    Calendar for Spectrum Training Classes

    Collaborative IRB Training Initiative (CITI)

    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.

    Next Steps

    Environmental Health and Safety Training

    Everyone in the Stanford Community is required to take some health and safety training. Many courses are available through AXESS- STARS Training.

    To clarify what safety training is necessary for each job function, Environmental Health and Safety courses are included on the Training Needs Assessment Tool located within STARS (Training). There is also an online tool that determines safety training for SU faculty, staff and students.

    Additional Resources

    Key Points
    • Complete the online training advisor through EHS or AXESS to determine health and safety training needs.
    • It is important to document and maintain training records.
    • Review Training Policies associated with health and safety at Stanford University.

    Next Steps

    Epic Training (for Access to Electronic Health Records)

    For more information regarding Epic Access and Training please go to "Electronic Medical Records".

    Epic Training is required for all staff who need access to hospital medical records.

    Key Points
    • Epic Training is required for all SHC physicians and medical staff who need access to hospital medical records.
    • Epic Training may be required of LPCH physicians and medical staff whose specialty, sub-specialty and scope of clinical practice indicate that access to Epic may be needed.

    Find a Workshop

    Good Clinical Practice at Stanford

    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
    Education and Training

    Stanford Courses

    • 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.
    Next Steps

    HealthStream for Postdoctoral Scholars (HSPD) Program

    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.

    Supervisors start here: Clinical Researchers Occupational Exposures Assessment Questionnaire

    Note: As of 10/14/13, the "Clinical Researchers Occupational Exposures Assessment Questionnaire" has replaced the HSSC assessment form.

    For more information, go to: http://spectrum.stanford.edu/accordions/staff-training/?ch2=8

    Questions? Contact EH&S Occupational Health and Safety Program (723-0448) for assistance if needed. Require additional assistance? Please contact:hssc-support@lists.stanford.edu

    HIPAA Training

    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.

    Next Steps

    HSSC — View Health Screening, Safety & Compliance Program

    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 and FAQs

    Arrow IconRegister for Spectrum Training

    Arrow Icon Memos, Updates, and Reminders

    Next Steps

    ICCR – Intensive Course in Clinical Research: Study Design & Performance

    The Spectrum Intensive Course in Clinical Research (ICCR) is a one-week immersion course designed for new clinical investigators, senior residents, fellows, and junior faculty interested in pursuing careers in clinical and translational research.

    Students spend five days and four late evenings immersed in all aspects of research study design and performance. The format combines didactics with intense group/team activities focused on practical issues in clinical research design—from selection of a researchable study question through actual writing of a research proposal. Lectures and panel discussions are presented by an accomplished faculty of Stanford clinical researchers and key leaders from the Stanford community. Every presentation includes a discussion of relevant issues.

    Sponsored by the Spectrum Programs: Career Diversity and Development Center; Center for Innovative Study Design; Child Health; Operations, Training and Compliance; and Research Education and Training.

    Click on any of the headings below for detailed information.

    Arrow Icon Background

    Arrow Icon Attending ICCR

    Arrow Icon Upcoming Course Dates

    Arrow Icon Prerequisite Reading

    Arrow Icon Modules

    Arrow Icon View Past Courses

    Arrow Icon ICCR Mentors

    Arrow Icon Testimonials

    Key Points
    • ICCR explores career advancement, time management, and challenges of clinical trials research; discussion of individual projects and opportunities for collaboration with peers and mentors.
    • ICCR inspires networking across departments with an extended network of colleagues, and provide resources to achieve successful clinical and translational research projects.
    • To attend ICCR the Stanford resident, fellow or junior faculty must be nominated by the Division Chief or Department Chair and be released from all clinical and work-related duties during the course week.

    Next Steps

    My Training Requirements Checklist

    My Training Requirements Checklist
    Training Name or Topic Faculty Research Personnel Postdocs
    Collaborative IRB Training Initiative
    (CITI)
    REQUIRED REQUIRED REQUIRED
    Environmental Health & Safety Training Assessment REQUIRED REQUIRED REQUIRED
    HIPAA Training REQUIRED REQUIRED REQUIRED
    Training for Sponsor Investigator Research (SIR) REQUIRED Recommended3 Not Applicable
    eProtocol Training Recommended Recommended Recommended
    GCP Training through CITI Recommended2 Recommended2 Recommended2
    Budgeting & Billing Training Recommended REQUIRED1 Recommended
    Health Screening, Safety & Compliance (HSSC) Program Not Applicable REQUIRED REQUIRED
    Orientation to Clinical Research at Stanford (General Orientation) Optional REQUIRED Recommended

    1 Required if involved in budgeting and billing, strongly recommended for personnel who enroll participants.

    2 Required of Cancer Center personnel.

    3 This training is a PI requirement, but research team members are strongly encouraged to attend at the same time.


    Overview of Clinical Research Resources at Stanford

    Description: This session will provide information on navigating the clinical research landscape at Stanford. The overview includes introductions to University Departments responsible for human subjects’ protection, research budget development, research contract negotiations and grant submissions. Information on obtaining medical services for research participants from Stanford Health Care (SHC) and Stanford Children’s Health (SCH) will be presented.

    Objectives:

    • Become familiar with the Stanford clinical research landscape
    • Learn which University departments to contact for human subjects’ protections and for research budgeting and contracts
    • Learn where to find contacts and information critical to conducting clinical research at Stanford Health Care, Stanford Children’s Health and the Clinical and Translational Research Unit (CTRU)
    Important Information
    • 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.
    • There are 2 components of this training:
      1. Classroom Presentation (locate slides in “Notes and Attachment” link upon enrollment)
      2. Evaluation (a link will be sent upon confirmation of classroom attendance)
    • Required for new staff participating in clinical research.
    • Recommended for postdoctoral scholars and new faculty.

    Next Steps

    Overview of Training Opportunities for Clinical Research 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.

    Next Steps

    Overview of Training Opportunities for Clinical Research Personnel

    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.

    Next Steps

    Overview of Training Opportunities for Postdoctoral Fellows & Residents

    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

    Next Steps

    Sponsor Investigator Research (SIR) Training

    Stanford Education Planning Initiative – SEPI

    Drug and Biologic Research

    The U.S. Food and Drug Administration website provides information for the Investigational New Drug (IND) Application. The site includes information and resources including:

    • Pre-IND Consultation Program
    • Guidance Documents for INDs
    • Laws, Regulations, Policies and Procedures
    • Emergency Use of an Investigational Drug or Biologic
    • Related Resources, including Applications

    Training

    Spectrum works in collaboration with the IRB and the Cancer Clinical Trials Office to provide education and training for investigators and research teams conducting research with INDs and IDEs held by a Stanford investigator.

    Next Steps

    Medical Device Research

    IDE Templates

    The U.S. Food and Drug Administration website provides information for regulated industry on determining how to comply with the federal laws and regulations governing medical devices. See their Device Advice: Device Regulation and Guidance page for the following information and more:

    • Overview of Medical Device Regulation
    • Compliance Activities (Medical Devices)
    • Postmarket Requirements
    • Standards

    Mobile Medical Application Resources

    Training

    Spectrum works in collaboration with the IRB and the Cancer Clinical Trials Office to provide education and training for investigators and research teams conducting research with INDs and IDEs held by a Stanford investigator.

    Medicare IDE Preauthorization

    ClinicalTrials.gov Registration and Results Posting

    Sunshine Act Open Payments

    The Center for Medicare and Medicaid Services (CMS) has published several quick guides and presentations to assist with physician registration.

    Tips and FAQs from the Vice Provost and Dean of Research website:


    Step One: Register with CMS Enterprise Portal

    Step Two: Register with CMS Open Payments System

    For more information about Open Payments, please visit the Open Payments website. If you have any questions, you can submit an email to the Help Desk at openpayments@cms.hhs.gov. Live Help Desk support is available by calling 1-855-326-8366, Monday through Friday, from 7:30 a.m. to 6:30 p.m. (CT), excluding Federal holidays.

    Regulatory Memos

    Study Tools and Templates

    Leadership — Operations, Training & Compliance

    Steven R. Alexander, MD
    Leader — Spectrum Operations, Training and Compliance
    Spectrum Medical Director
    Professor of Pediatrics
    Phone: (650) 723-7903
    Email: email



    Program Contact Information

    Spectrum – Operations, Training and Compliance (OTC)

    Physical Location:
    800 Welch Road
    MC: 5737
    Palo Alto, CA 94304

    Mailing Address:
    300 Pasteur Drive
    Stanford, CA 94305-5737

    Email: Spectrum OTC  email

    Fax: (650) 723-8552

    ...................
    Additional personnel contact information can be found below.

    Personnel Directory – OTC

    Steven R. Alexander, MD
    Spectrum Medical Director
    Phone: (650)723-7903
    Email: email

    Jennifer Brown, RN
    Manager, Regulatory Services & Education
    Phone: (650) 736-1730
    Email: email

    Anna Hu, RN, MPH
    Manager, Research Coordinator Services
    Phone: (650) 498-7921
    Email: email

    Jessica P. Meyer, MBA
    Program Coordinator
    Phone: (650) 498-6140
    Email: email

    Peg Tsao, RN, BSN, CCRC
    Study Facilitator
    Phone: (650) 736-9710
    Email: email


    Program Administrator
    Email: email


    OTC – WHO TO CALL

    ADMINISTRATION

    OTC Program Administrator

    BUDGETING AND BILLING

    Initial Budget Questions

    All initial budget questions should go to your Research Process Manager (RPM)

    Spectrum OTC Budgeting and Billing

    Anna Hu, RN, MPH
    Manager, Research Coordinator Services
    (650) 498-7921

    Cancer Budgeting and Billing

    Monique Bertrand
    (650) 724-4428

    CLINICAL RESEARCH COMPLIANCE AND REGULATORY

    Jennifer Brown, RN
    Manager, Regulatory Services & Education
    (650) 736-1730

    CLINICAL TRIALS

    Jennifer Brown, RN
    Manager, Regulatory Services & Education
    (650) 736-1730

    Questions about Clinical Trials

    OTC Program Administrator

    Information about Participating in a Clinical Trial (non-cancer) –

    Operations, Training & Compliance (OTC)
    (650) 498-7425

    Information about Participating in a Clinical Trial (cancer/oncology) –

    Cancer Clinical Trials Office (CCTO)

    Information about having Stanford as a potential site for your trial

    [see Industry Relations]

    EDUCATION AND TRAINING

    Jessica P. Meyer, MBA
    Program Coordinator
    (650) 498-6140

    STUDY FACILITATOR SERVICES

    General Assistance

    StudyFacilitator@stanford.edu

    Study Facilitators

    Peg Tsao, RN, BSN, CCRC
    (650) 736-9710

    WEBSITE

    Please report website problems to email