Stanford

Design Study

SDD

Spectrum support for Clinical Research is divided into four stages, the first of which is DESIGNING YOUR STUDY.

This stage includes tasks and activities that occur early in the design & development of a study, such as:

  • biostatistics consultations
  • informatics consultations
  • bioethics consultations
  • identifying co-investigators and collaborators
  • exploring funding opportunities

What should I do in the Study Design stage?

1.  Evaluate Your Study Idea
2.  Explore Funding Opportunities
3.  Find a Collaborator or Mentor
4.  Seek Study Design Assistance
5.  Look into Available Resources
6.  Learn about Regulatory Requirements

For detailed information, open the color-coded items below this key.

GUIDANCE — 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?

Evaluate your study idea!

  • What is your objective?
  • What is your research hypothesis, or what question are you trying to answer?
  • Is your study idea feasible/possible?
  • Are the population and demographics available to complete your research?
  • Has this research been attempted before?
  • What were the successes, failures, limitations?

Spectrum Funding

Spectrum Pilot Grants

Spectrum provides pilot funding for projects in:

  • Therapeutics (drug discovery and development)
  • Medtech
  • Predictives and Diagnostics
  • Population Health Sciences
  • Community Engagement

See the Innovations and Pilots page for more details.

Spectrum Child Health Funding

Spectrum Child Health administers several funding programs to facilitate and support the best child-health focused research at Stanford.

Spectrum Administrative Supplements

Occasionally NIH funds Administrative Supplements to the parent grant that supports Spectrum. Currently open or recently funded opportunities are posted below.

  • CTSA Administrative Supplement Funding Opportunity #1
    (recently funded)
    Supplements to support new or ongoing bench-to-bedside T1-type research (collaboration between faculty at two or more CTSA sites) (up to $500,000 total costs for 1 year)
  • CTSA Administrative Supplement Funding Opportunity #2
    (recently funded)
    Study design, especially as applied to comparative effectiveness research (up to $300,000 total costs for one year)
Other Internal Funding Opportunities

Research Management Group (RMG) is the primary source for information on internal funding opportunities for support of pilot projects.


Stanford, SoM & External Funding Opportunities

Please refer to the Research Management Group website which provides information about all the funding opportunities below.

  • External funding opportunities
    CIRM, DoD CDMRP, HHMI, NIH, and NSF, and others
  • Internal funding opportunities
    Seed grants, pilot funding, development projects, postdoctoral fellowships, graduate student funding opportunities
  • Junior and new faculty resources
  • Spectrum funding
    Also see "Spectrum Funding" (above article). 
More information

Identify Co-investigators, Collaborators & Mentors

  • Use Community Academic Profiles (CAP)  to explore profiles and publications of Stanford faculty and postdocs. Use CAP's search and auto-relate tools to find subject-matter experts, people with similar interests, available mentors and more.
        —  Enter your SUNet ID to view complete information in CAP Network.
        —  Click on the “Find a Mentor” tab to view specific areas of availability of potential mentors.
  • The Pediatrics Mentoring Program promotes the career development of early-career investigators in Pediatrics at Stanford through a formal mentoring program and stable of mentors.

Identify a Patient Cohort for Research

The STRIDE Cohort Discovery Tool provides a self-service method for asking questions to help identify a cohort of patients for a potential study. Search criteria can include demographics, diagnosis and procedure codes (ICD-9 and CPT), test results, and text search of clinical documents. This service is provided by Stanford Research IT (RIT).

For Cancer-related patient cohorts contact Stanford Cancer Institute Research Database (SCIRDB). We can help you build a cohort using diagnoses, procedure codes (ICD-9 or ICD-O), and billing codes (CPT). We can help you do complex searches involving dictations and other notes and we can identify which people have tissue stored in the Stanford Tissue bank.

Next Steps

Request a Consultation — Ethics (Benchside)

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.

Next Steps

Research Data Management Best Practices (consultation)

Stanford Research IT (RIT) consultants will review options for research data management. The consultant will:

  • discuss the trade-offs of various approaches, including REDCap, STRIDE Secure Workbench, STRIDE-DM, and commercial software
  • summarize research data management best practices and
  • describe the support that RIT can provide to you toward meeting regulatory requirements such as FDA Part 11.

Stanford Cancer Institute Research Database (SCIRDB) will consult with you about research data management for cancer and disease groups.

Next Steps

Review Project for HIPAA, Privacy & Security Requirements

Stanford Research IT (RIT) consultants will:

  • review your research project from a HIPAA perspective
  • help identify areas of risk
  • provide recommendations to achieve regulatory compliance and follow data security best practices

Consultants will also provide assistance in:

  • meeting data privacy and security requirements for IRB submission
  • biomedical research privacy and security regulatory compliance
  • securing PHI on your computer

The Stanford Cancer Institute Research Database (SCIRDB) provides cancer investigators with a secure environment to store their data. We implement measures for both physical and data security. We use Secure Socket Layer (SSL) connections when providing researchers to role-based access the data over the web. We continuously monitor and upgrade security procedures as necessary. We work with the Stanford University Privacy and Data Security Officer to comply with all HIPAA regulations as they pertain to a project.

Next Steps

Biomedical Ethics — Information & Consultations

The Spectrum BIOMEDICAL ETHICS program is handled by the Stanford Center for Biomedical Ethics (SCBE).   This program: 

  • provides research ethics consultations to basic science and clinical researchers whose projects raise ethical and social concerns.
  • provides interdisciplinary research and education in biomedical ethics.
  • serves as a scholarly resource on emerging ethical issues raised by medicine and biomedical research.

ALSO SEE

Clinical Informatics — Information & Consultations

Stanford Research IT (RIT) provides a variety of services to facilitate clinical and translational research:

  • Access to SUMC Clinical Data for Research Purposes
  • Research Data Management Solutions
  • Real-time Research Alerting
  • Biospecimen Data Management
  • Privacy and Security
  • RIT consultants can also help review your project's data management and informatics needs and assist with developing a budget and Informatics/IT support proposal section for your grant prior to submission.
  • For additional information, schedule a free consultation.

Stanford Cancer Institute Research Database (SCIRDB) will consult with you about research data management for cancer and disease groups. For additional information, send e-mail to ccdb-consult@lists.stanford.edu with a brief description of your research interests.

Next Steps

Biostatistics & Study Design — Information & Consultations

The Stanford Center for Clinical and Translational Education and Research (Spectrum), in association with the Department of Biomedical Data Science, offers a free one-hour consultation on study design.

Find out more about the services offered by the Department of Biomedical Data Science, including help on a grant application or study protocol (design, statistical plans, power and sample size, database design).

Discussion topics of interest include:

  • Statistical design, sample size and power
    (Consultants: McMillan, Narasimhan, Tamaresis)
  • Statistical analysis of preliminary data (limited availability)
    (Consultants: McMillan, Tamaresis)
  • Other data management issues (e.g. validation) – data entry services not available
  • Advice on analyzing data
    (Consultants: McMillan, Tamaresis)
  • Statistical analysis of data (limited availability)
    (Consultants: McMillan, Tamaresis)
  • Formulating a statistical analysis plan
    (Consultants: McMillan, Narasimhan, Tamaresis)
  • Organizing your data for capture into a database
  • Statistical support for Data Safety Monitoring Board (limited availability)
  • Advice on responding to journal review
    (Consultants: McMillan, Narasimhan, Tamaresis)
  • Help in designing a cancer clinical protocol
    (Consultants: McMillan, Narasimhan, Tamaresis)

Prior to your appointment:


Resources
Next Steps

Study Design Workshop

The Study Design Workshop (SDW) provides an opportunity for biomedical researchers who are designing a study to meet with members of the biostatistics staff at Stanford and collaboratively develop a research plan.

The researchers typically provide a brief orientation to the problem they are trying to solve and then have a collegial conversation with world class experts on all aspects of study design including sample size, statistical analysis methods and data management. The conversations always center around the idea of how to design the optimal study, which will afford the opportunity to make inferences to the world using as few subjects as possible.

Researchers leave the SDW with well thought through, specific aims and the core methods sections needed for preparing grants and conducting a successful research project.

The SDW forms long term teams to assure that biostatisticians can see a study through to its completion.


Clinical Data Related to Research | Electronic Health Record

CTRU — Clinical and Translational Research Unit

The Clinical and Translational Research Unit (CTRU) provides resources to faculty conducting both CHILD HEALTH and ADULT research at Stanford School of Medicine. It is now located at the new Freidenrich Center for Translational Research, at 800 Welch Road.

Next Steps

Enabling Technology Core Resources

Numerous core facilities at Stanford enable cutting-edge clinical and translational research.

Research Data Management Tools

Stanford School of Medicine offers a number of data capture platforms to facilitate clinical research, all of which are recommended over the more traditional choices of Excel, Filemaker Pro and Access, since all three fail to satisfy the HIPAA Privacy Rule requirements.

Data security and privacy reviews: These are conducted by the University Privacy Office, UIT Security and the Information Security Office. Projects using high risk data (which includes PHI) must request a data risk assessment by completing the intake process described here.

  • STRIDE-DM, the Data Management application development platform of the Stanford Translational Research Integrated Database Environment, was developed by Stanford Research IT (RIT). It supports the design of custom research data capture systems and also offers integration with the STRIDE Clinical Data Warehouse, which contains both current and historic clinical data from both LPCH and SHC. STRIDE-DM research data management systems are all custom-built by RIT application developers in exchange for salary support to cover the time spent building the database. There is an annual maintenance fee.
  • REDCap is a self-service system where the researcher defines the database fields either in a spreadsheet or with the help of user-friendly web tools; once the database fields have been finalized, you can start entering data immediately. RIT offers complementary support during the process of defining and refining your database. There is no annual maintenance fee, thanks in part to funding from the Stanford CTSA (Spectrum).
  • STRIDE Secure Workbench is a remote desktop platform allowing researchers to analyze sensitive data with 3rd party software in a secure environment.
  • Additional commercial products are also available, such as Medrio (frequently used in drug trials).

Stanford Cancer Institute Research Database (SCIRDB) consults on research data management for cancer and disease groups. Patient data can be provided in formats such as:

  • A custom web-based display that shows columns of data for the fields identified in the data dictionary.
  • A REDCap database that allows researchers to browse and edit entries for each patient.

The SCIRDB infrastructure offers the following technological capabilities to clients.

  • Modern database management with entry and access over the Web when necessary with rigorous attention to the quality of the data
  • Establishment and maintenance of databases that can be scaled to increase in size seamlessly as they evolve in terms of hardware, algorithms, and needs of particular projects
  • Development of tools for rapid prototyping of data forms and relationships among sources of data, including porting data from laboratory instrumentation to integrated central databases
  • Provision of access to various secondary databases, including extensive links to publicly available databases
Next Steps

IRB Approval

Before your study begins, you must have IRB approval. 

  • Use eProtocol to submit your protocol to the IRB. Investigators may submit their protocols any time.
  • The Panels will review all protocols that are filled out correctly and completely within approximately 4-6 weeks. 

Next Steps

Regulatory & Compliance — Support Services, Resources and QuickLinks

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

Calendar — Spectrum Training Calendar

Overview of Training Opportunities for Clinical 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

Participate in the Study Design Workshop

The Study Design Workshop (SDW) provides an opportunity for biomedical researchers who are designing a study to meet with members of the biostatistics staff at Stanford and collaboratively develop a research plan.

The researchers typically provide a brief orientation to the problem they are trying to solve and then have a collegial conversation with world class experts on all aspects of study design including sample size, statistical analysis methods and data management. The conversations always center around the idea of how to design the optimal study, which will afford the opportunity to make inferences to the world using as few subjects as possible.

Researchers leave the SDW with well thought through, specific aims and the core methods sections needed for preparing grants and conducting a successful research project.

The SDW forms long term teams to assure that biostatisticians can see a study through to its completion.


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

Sponsor Investigator Research (SIR) Training

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.

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

Stanford Education Planning Initiative – SEPI

Assistance with Proposals — Budget and Informatics & IT Support Section

Stanford Research IT (RIT) consultants will help review your project's data management and informatics needs and assist with developing a budget and Informatics/IT support proposal section for your grant prior to submission.

Stanford Cancer Institute Research Database (SCIRDB) personnel work with you to plan for your needs related to cancer projects. The ideal engagement occurs when either you are formulating the project or writing the grant application. The planning phase involves:

  • Determining the duration and requirements of the project
  • Determining how the investigators would interact with project data
  • Estimating the resources (hardware, software, and personnel) needed for a project
  • Charting a timeline for execution of the deliverables with specified milestones
Next Steps

Boilerplate Text for Grant Proposals — Freidenrich Center and CTRU Description

Boilerplate text describing the FCTR (Freidenrich Center for Translational Research), and the CTRU facilities in the new FCTR space is available for use in your grant proposals. Download this Word document that can be used in your documents (e.g., grant proposals); it can be edited as necessary to fit your needs. Check the date of boilerplate text to ascertain that it is current for your needs.

Next Steps

Boilerplate Text for a Grant Proposal — Spectrum Description

Boilerplate text describing Spectrum programs and services is available for use in your grant proposals. Several versions, varying in amount of detail, are available in a Word document. Check the date of boilerplate text to ascertain that it is current for your needs.

Next Steps

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

Shared Resources

TRAM, Translational Research and Applied Medicine Program

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.

Next Steps