Design Study

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

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

Getting Started

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

Regulatory Requirements

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

Budget and Billing Matters

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

Staffing Needs

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

Grant and Contract Processes

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

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 Opportunities
• Contact Spectrum Child Health Administration , or call (650) 724-6891

Spectrum Administrative Supplements

Occassionally 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.

• RMG Internal Funding Opportunities website
  

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). 

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 the Stanford Center for Clinical Informatics.

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.

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.

Stanford Center for Clinical Informatics (SCCI) consultants will review options for research data management. The consultant will:

• discuss the tradeoffs of various approaches, including REDCap, STRIDE Secure Workbench, STRIDE-DM, and commercial software
• summarize research data management best practices and
• describe the support that SCCI 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.

Stanford Center for Clinical Informatics (SCCI) 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.

The Stanford Center for Clinical Informatics (SCCI) 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
• SCCI 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.

Spectrum, in association with the Department of Health Research and Policy – Center for Innovative Study Design (CISD), offers a free one-hour consultation for help with all aspects of study design, including ethics, biostatistics and data collection.

Discussion topics of interest:

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

Prior to your appointment:

• Review Guidelines for Pre-Award Statistical Consultation with SPCTRM (pdf)
• In order to assist you with preparing your data collection tools, see Guidelines for Describing Data as it Relates to Data Collection and Analysis. These codes will help you, and if applicable, your biostatistician when it is time to evaluate/analyze the data. – Data Submission (pdf)
• Example for building your code book/data dictionary – Sample Form (pdf)
• Data collection code book – Variable Information (xls)

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.

Stanford Center for Clinical Informatics (SCCI) is the official SUMC clearinghouse for all clinical data requests related to research. The Stanford Cancer Institute Research Database (SCIRDB) team collaborates with many groups, including Stanford IRT, to obtain data in an electronic format on every patient seen and/or treated for cancer at Stanford.

With access to clinical data from the Electronic Health Records of both hospitals, SCCI can meet your clinical research data needs, either via our self service online tools or with an in-person consultation. SCIRDB can help you build a cohort, do complex searches involving dictations and other notes, and identify subjects who have tissue stored in the Stanford Tissue bank.

The STRIDE Clinical Data Warehouse contains electronic clinical data from both SHC and LPCH, including:

• patient demographics
• ICD-coded diagnoses
• CPT-coded procedures
• clinical documents
• surgical pathology reports
• radiology reports and laboratory test results

The SCIRDB has a rich set of data which integrates many resources including:

• EPIC
• STRIDE
• specialized databases in surgical pathology and radiation oncology
• Stanford Cancer Registry
• Social Security Death Index (SSDI)

Consultants from the Stanford Center for Clinical Informatics (SCCI) can review the clinical data needs of your research project, provide advice on requesting IRB approval to obtain clinical data from STRIDE and discuss options for clinical data abstraction, reporting and storage to meet your research needs. SCIRDB consults on research data management for cancer and disease groups. SCIRDB consultants provide extensive tools for browsing and searching existing data, can integrate a cohort’s data with tools like REDCap to facilitate the curation of existing data, and help with the addition of study-specific information.

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.

• Clinic Space
• Research Nursing Services
• Clinical Lab Services
• Dietary Services
• Learn more about CTRU services
• Learn more about Child Health services

To request CTRU services complete the CTRU Request Form, available only in Study Navigator (see Next Steps, to the right).

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 satisfy the HIPAA Privacy Rule requirements.

• STRIDE-DM, the Data Management application development platform of the Stanford Translational Research Integrated Database Environment, was developed by the Stanford Center for Clinical Informatics (SCCI). 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 SCCI 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. SCCI 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), or Oracle Axis.

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

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. 

Regulatory and Compliance support services provided by OTC include:

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

QuickLinks

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

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.

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.

Spectrum OTC provides education, required training and professional growth opportunities to the Stanford clinical research community.

Whether new to Stanford or in need of a refresher course, the below list of training programs provides the information necessary to successfully conduct clinical research at Stanford.

REQUIRED TRAINING FOR CLINICAL RESEARCH FACULTY

• Collaborative IRB Training Initiative (CITI)* (Required)
  Required human subjects training for all staff who work on research projects (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting).  More »
• Environmental Health and Safety Training Assessment
  Everyone in the Stanford community is required to take some safety training. To clarify what safety training is necessary for each job function, Environmental Health and Safety developed the Training Assessment online tool for determining what safety training a SU employee needs to take.  More »
• HIPAA Training
  Stanford HIPAA training is required for every member of the workforce who comes into contact with Protected Health Information (PHI).  More »
• Training for Sponsor Investigator Research (SIR)
  Required for investigators who intend to obtain their own Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications from FDA.  More »

RECOMMENDED TRAINING

• eProtocol Training
  eProtocol is an online application used at Stanford to submit, review, and approve research (human subjects; stem cells; animal subjects; and biosafety).  More »
• GCP Training through CITI
  If you are new to research or just need a refresher course, Good Clinical Practice (GCP) guidelines are available on-line through the IRB’s CITI training.  More »
• Budgeting and Billing Training
  Required for all new and current employees who work on clinical research projects, if involved in budgeting and billing. Spectrum OTC offers monthly training sessions.  More »
• Orientation to Clinical Research at Stanford (General Orientation)
  Required for new employees who are working in clinical research. At this orientation Spectrum OTC staff will meet with clinical research personnel to provide resources and tools to successfully navigate research studies at Stanford.  More »

EDUCATION / WORKSHOPS

• ICCR – Intensive Course in Clinical Research: Study Design and Performance
  The Intensive Course in Clinical Research (ICCR) is a one-week immersion course developed at Stanford for new clinical investigators, senior residents, fellows and junior faculty, interested in pursuing careers in clinical and translational research. More »
• Find a Workshop
  View upcoming CTR educational workshops offered by Spectrum and affiliates, past presentations and videos, a list of courses, or request a workshop.  More »

MENTORING

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

OTHER TRAINING RESOURCES – STANFORD

• Spectrum Child Health
  Spectrum Child Health offers a centralized clinical core with research support personnel, assistance with scientific expertise and advice, and career development training for junior investigators. More »
• Epic Training
  Epic Training is required for all Stanford Hospital and Clinics physicians and medical personnel who need access to Hospital Medical Records.
  Training is completed online. The specific courses that you are required to complete are dependent on your specialty, sub-specialty and scope of clinical practice.  More »
• Lane Library
  Lane Library’s instructional program supports clinical and bioresearch clientele with a class list that includes PowerPoint; Finding Funding; Basics of R Programming; Improving Your Scientific Writing Skills, and dozens more.  More »
• Tech Training
  Stanford University Information Technology Services (ITS) provides technology courses. See the ITS website for training options in the classroom, online, one-on-one by appointment, and custom classes.  More »
• STARS
  The Stanford Training And Registration System (STARS) is Stanford's Learning Management System. Log in to Axess to see the STARS Training website which includes a “STARS Browse Catalog” and a “Training Needs Assessment” tool.  More »
• Learning and Development
  Information and awareness of resources for courses, programs, and conferences useful to any staff member for professional development.  More »
• Leadership Training
  The Office of Diversity and Leadership provides several programs that enable faculty to build and develop leadership skills.  More »
• Cancer Clinical Trials Office (CCTO)
  The Cancer Clinical Trials Office provides regulatory, administrative, research, and educational services to Cancer Center investigators conducting clinical trials.  More »
• Office of Sponsored Research (OSR)
  Provides pre- and post-award administration of sponsored projects to the University.  More »

PROFESSIONAL DEVELOPMENT RESOURCES – NON-STANFORD

• ACRP
  ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings.  More »
• University of California Santa Cruz, Extension
  The UCSC Extension Certificate in Clinical Trials Design and Management is designed to help professionals gain a solid understanding of the entire clinical trials process, as well as a foundation in the scientific principles, regulations, and ethics that are vitally important to the conduct of clinical research.  More »
• San Francisco State University Extension
  Through the Clinical Trial Design and Management Certificate Program students may complete a full certificate or simply take those courses which advance their own professional goals. The program is designed to be flexible for working adults by offering evening or weekend courses.  More »
• University of California Berkeley Extension
  UC Berkeley Extension offers a Certificate Program in Clinical Research Conduct and Management which enables you to master practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines, and ethical considerations.   More »

Key Points

• Some of this training is required before any research participants can be enrolled in a clinical study.
• You are responsible for maintaining training compliance for yourself, and if you are a PI, that of your research team.

Spectrum OTC provides education, required training and professional growth opportunities to the Stanford clinical research community.

Whether new to Stanford or in need of a refresher course, the below list of training programs provides the information necessary to successfully conduct clinical research at Stanford.

REQUIRED TRAINING FOR CLINICAL RESEARCH PERSONNEL

• Collaborative IRB Training Initiative (CITI)* (Required)
  Required human subjects training for all staff who work on research projects (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting). More »
• Orientation to Clinical Research at Stanford (General Orientation)
  Required for new employees who are working in clinical research. At this orientation Spectrum OTC staff will meet with clinical research personnel to provide resources and tools to successfully navigate research studies at Stanford. More »
• Health Screening, Safety and Compliance Training
  Required for all non-faculty Stanford School of Medicine clinical research personnel (and postdocs) involved with human subject research. Supervisor to complete Clinical Researchers Occupational Exposures Assessment Questionnaire on new employee/postdoc's behalf.

  More »

• Budgeting and Billing Training
  Required for all new and current employees who work on clinical research projects, if involved in budgeting and billing. Spectrum OTC offers monthly training sessions.  More »
• Environmental Health and Safety Training Assessment
  Everyone in the Stanford community is required to take some safety training. To clarify what safety training is necessary for each job function, Environmental Health and Safety developed the Training Assessment online tool for determining what safety training a SU employee needs to take.  More »
• HIPAA Training
  Stanford HIPAA training is required for every member of the workforce who comes into contact with Protected Health Information (PHI).  More »

RECOMMENDED TRAINING

• eProtocol Training
  eProtocol is an online application used at Stanford to submit, review, and approve research (human subjects; stem cells; animal subjects; and biosafety).  More »
• GCP Training through CITI
  If you are new to research or just need a refresher course, Good Clinical Practice (GCP) guidelines are available on-line through the IRB’s CITI training.  More »

EDUCATION / WORKSHOPS

• Find a Workshop
  View upcoming CTR educational workshops offered by Spectrum and affiliates, past presentations and videos, a list of courses, or request a workshop.  More »
• Request a Workshop
  View list of workshop topics, or suggest a topic.  More »

OTHER TRAINING RESOURCES – STANFORD

• Lane Library
  Lane Library’s instructional program supports clinical and bioresearch clientele with a class list that includes PowerPoint; Finding Funding; Basics of R Programming; Improving Your Scientific Writing Skills, and dozens more.  More »
• Epic Training
  Epic Training is required for all Stanford Hospital and Clinics physicians and medical personnel who need access to Hospital Medical Records.
  Training is completed online. The specific courses that you are required to complete are dependent on your specialty, sub-specialty and scope of clinical practice.  More »
• Cardinal Curriculum
  Cardinal Curriculum is designed to develop Stanford's research administration workforce by providing tools for individuals to build competencies, increase efficiency, and improve compliance with Stanford and sponsor requirements. Training classes, which can lead to certification, are organized into two levels and are geared to individuals as they develop from novice to expert in research administration.
  These classes will benefit research administrators and all administrative staff who support sponsored research.
  More »

• Cancer Clinical Trials Office (CCTO)
  The CCTO provides training and quality assurance programs for both new and existing research staff to ensure that Cancer Institute research staff are current on all regulatory requirements as well as SCI standard operating procedures.  More »
• Tech Training
  Stanford University Information Technology Services (ITS) provides technology courses. See the ITS website for training options in the classroom, online, one-on-one by appointment, and custom classes.  More »
• STARS
  The Stanford Training And Registration System (STARS) is Stanford's Learning Management System. Log in to Axess to see the STARS Training website which includes a “STARS Browse Catalog” and a “Training Needs Assessment” tool.  More »
• Learning and Organizational Effectiveness
  LOE Calendar of Course, Programs, and Conferences.  More »
• Office of Sponsored Research (OSR)
  The OSR website provides a list of recommended classes for those working with sponsored research.  More »

PROFESSIONAL DEVELOPMENT RESOURCES – NON-STANFORD

• ACRP
  ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings.  More »
• University of California Santa Cruz, Extension
  The UCSC Extension Certificate in Clinical Trials Design and Management is designed to help professionals gain a solid understanding of the entire clinical trials process, as well as a foundation in the scientific principles, regulations, and ethics that are vitally important to the conduct of clinical research.  More »
• San Francisco State University Extension
  Through the Clinical Trial Design and Management Certificate Program students may complete a full certificate or simply take those courses which advance their own professional goals. The program is designed to be flexible for working adults by offering evening or weekend courses.  More »
• University of California Berkeley Extension
  UC Berkeley Extension offers a Certificate Program in Clinical Research Conduct and Management which enables you to master practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines, and ethical considerations.   More »

Key Points

• Some of this training is required before any research participants can be enrolled in a clinical study.
• You are responsible for maintaining training compliance for yourself, and if you are a PI, that of your research team.

RECOMMENDED TRAINING

• eProtocol Training
  eProtocol is an online application used at Stanford to submit, review, and approve research (human subjects; stem cells; animal subjects; and biosafety).  More »
• GCP Training through CITI
  If you are new to research or just need a refresher course, Good Clinical Practice (GCP) guidelines are available on-line through the IRB’s CITI training.  More »
• Budgeting and Billing Training
  Required for all new and current employees who work on clinical research projects, if involved in budgeting and billing. Spectrum OTC offers monthly training sessions.   More »
• Orientation to Clinical Research at Stanford (General Orientation)
  Required for new employees who are working in clinical research. At this orientation Spectrum OTC staff will meet with clinical research personnel to provide resources and tools to successfully navigate research studies at Stanford. More »

EDUCATION / WORKSHOPS

• ICCR – Intensive Course in Clinical Research: Study Design and Performance
  The Intensive Course in Clinical Research (ICCR) is a one-week immersion course developed at Stanford for new clinical investigators, senior residents, fellows and junior faculty, interested in pursuing careers in clinical and translational research. More »
• Find a Workshop
  View upcoming CTR educational workshops offered by Spectrum and affiliates, past presentations and videos, a list of courses, or request a workshop.  More »
• Request a Workshop
  View list of workshop topics, or suggest a topic.  More »

OTHER TRAINING RESOURCES – STANFORD

• Spectrum Child Health
  
  • Pediatrics Mentoring Program
    The Pediatrics Mentoring Program is dedicated to the academic enrichment and success of early career investigators in the Department of Pediatrics. More »
  • ICCR – Intensive Course in Clinical Research: Study Design and Performance
    The Intensive Course in Clinical Research (ICCR) is a one-week immersion course developed at Stanford for new clinical investigators, senior residents, fellows and junior faculty, interested in pursuing careers in clinical and translational research. More »
• Lane Library
  Lane Library’s instructional program supports clinical and bioresearch clientele with a class list that includes PowerPoint; Finding Funding; Basics of R Programming; Improving Your Scientific Writing Skills, and dozens more.  More »
• Epic Training
  Epic Training is required for all Stanford Hospital and Clinics physicians and medical personnel who need access to Hospital Medical Records.
  Training is completed online. The specific courses that you are required to complete are dependent on your specialty, sub-specialty and scope of clinical practice.  More »
• Cancer Clinical Trials Office (CCTO)
  The CCTO provides training and quality assurance programs for both new and existing research staff to ensure that Cancer Institute research staff are current on all regulatory requirements as well as SCI standard operating procedures.  More »
• Tech Training
  Stanford University Information Technology Services (ITS) provides technology courses. See the ITS website for training options in the classroom, online, one-on-one by appointment, and custom classes.  More »
• STARS
  The Stanford Training And Registration System (STARS) is Stanford's Learning Management System. Log in to Axess to see the STARS Training website which includes a “STARS Browse Catalog” and a “Training Needs Assessment” tool.  More »
• Learning and Organizational Effectiveness
  LOE Calendar of Course, Programs, and Conferences.  More »
• Office of Sponsored Research (OSR)
  The OSR website provides a list of recommended classes for those working with sponsored research.  More »

PROFESSIONAL DEVELOPMENT RESOURCES – NON-STANFORD

• ACRP
  ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings.  More »
• University of California Santa Cruz, Extension
  The UCSC Extension Certificate in Clinical Trials Design and Management is designed to help professionals gain a solid understanding of the entire clinical trials process, as well as a foundation in the scientific principles, regulations, and ethics that are vitally important to the conduct of clinical research.  More »
• San Francisco State University Extension
  Through the Clinical Trial Design and Management Certificate Program students may complete a full certificate or simply take those courses which advance their own professional goals. The program is designed to be flexible for working adults by offering evening or weekend courses.  More »
• University of California Berkeley Extension
  UC Berkeley Extension offers a Certificate Program in Clinical Research Conduct and Management which enables you to master practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines, and ethical considerations.   More »

Key Points

• Some of this training is required before any research participants can be enrolled in a clinical study.
• Most training required for postdocs is managed by your department administrator

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.

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.

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.

Key Points

• Understand your SIR requirements to ensure FDA compliance
• SIR training must be completed prior to IRB approval

Budgeting and Billing Training is required for all new and current employees working on clinical research projects, if involved in budgeting and billing (i.e. research coordinators enrolling study participants).

Training provides a general overview of the clinical research budgeting and billing process. It includes the Budgeting and Billing workbook process; billing procedures; and a review of the Medicare NCD policy.

This 2-hour training is offered monthly. Special training sessions are available for groups or departments upon request.

Key Points

• Recommended for all research personnel who enroll study participants.

The 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.

Stanford Center for Clinical Informatics (SCCI) 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

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.

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.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard, published by the International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

Good Clinical Practice guidelines include the protection of human rights, safety and welfare during clinical trials. They also assure clinical data integrity.

Good Clinical Practice guidelines include standards on how clinical trials should be conducted; and define the roles and responsibilities of clinical trial sponsors, clinical research investigators and monitors.

Useful Links

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

Education and Training

Stanford Courses

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

• Good Clinical Practice Fundamentals Course
  This one-day course is designed for new clinical research coordinators, nurses and administrative staff, who have limited experience with and no formal training in Good Clinical Practices (GCP). It offers a comprehensive yet concentrated overview of the principles of GCP, FDA and Global Regulations, and the roles and responsibilities of the clinical investigator/site, IRB, sponsor, and study monitor. Emphasis is placed on the translation of GCP principles to the concepts of protocol adherence, informed consent process, good documentation practices, event reporting, and proactive preparation for FDA/Regulatory audits. Interactive exercises and case scenarios facilitate the application of these principles into everyday practice governing the conduct of clinical trials.
• GCP Beyond the Basics
  For more experienced research coordinators, nurses and staff who are already familiar with basic GCP principles and are looking for more detail in areas of interest, four--hour sessions offer expanded instruction in selected GCP areas such as adverse event reporting, informed consent, and audit readiness.
• GCP Brown Bags
  The Good Clinical Practice (GCP) Brown Bag sessions are informal monthly meetings open to anyone in the Stanford research community. Brown Bags offer a chance to meet people outside your department, to discuss topics of interest, ask questions and exchange solutions to common challenges. Past sessions have included discussions on working with non-English speakers, consenting participants over the phone and via mail, drug accountability, good documentation, recruitment, research with devices, and more.
• Meetings occur on the fourth Thursday of each month from 11:30 – 12:30pm. View the Spectrum Education Calendar for details and topics.

• Enabling Technology Core Resources
  Resources are listed by category. The site includes links to:
  A to Z List of Service Centers (includes acronyms/alternate names for centers, website URLs, and contact information for each); and
  School of Medicine List of Available Equipment (includes equipment description, manufacturer, location and contact information for each)

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.