Set Up 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). 

Roles and Responsibilities

Research Management Group describes roles and responsibilities for proposal preparation and submission.

Institutional Facts

Both Research Management Group and DoResearch provide institutional facts such as:

Boilerplate text for proposals

Boilerplate text describing programs, resources and facilities – download these Word documents; you can edit as necessary to fit your needs.

• Spectrum
  Description of Spectrum programs and services
• Freidenrich Center for Translational Research (FCTR) and the CTRU
  Description of the FCTR and CTRU facilities and resources

Clinical Trials

See the RMG website: Clinical Trial Program and Resources for information such as:

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

Research Budgeting & Billing Support

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

Key Points

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

Stanford Hospital and Clinics

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

Lucile Packard Children's Hospital (LPCH)

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

CTRU

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

Key Points

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

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

What does a Research Coordinator do?

The duties of a research coordinator may include:

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

Do you need a registered nurse?

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

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

Do you need a research coordinator or data manager?

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

Are there special staffing considerations for a very large project?

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

Decision tree to help investigators in hiring research staff

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

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

• Critical Decision Skills
  • Protocol Management
  • Subject Safety
  • AE management

• Knowledge Base
• Recruitment
• Consenting
• Education

• Assessment
• Screening
• AE management
• Subject follow up

• Extraction and Analyzation and Interpretation of Information/Data
• AE reporting
• Management of abnormal values, etc.
• Source documentation and CRF completion

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

• Protocol Complexity
  • Is the Protocol an IND or IDE?
  • Will subjects be consented during routine clinic visits?
  • Does the protocol require multiple follow up visits?
  • Will there be an outside resource used for study related procedures
  • Are there any procedures that require a licensed nurse?
  • Do the follow up clinic visits require interventions, i.e. vital signs, wound care, lab draws, and study medication administration?
  • Are there multiple protocol related procedures, i.e. labs, EKG, radiology etc

• Subject Population
• Healthy volunteers
• Rare disease
• Multiple co-morbidities
• Newly diagnosed disease process
• Are these subjects with existing chronic illnesses?
• Are these subjects enrolled in a critical care setting, i.e. ICU/ED
• What is the emotional status of subject during recruitment and consent process?
• Age of subject

Location for Study Conduct

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

Coordination

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

Education and Communication

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

Resources for Finding a Coordinator

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

Resources for Child Health

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

Jobs

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

Subscribe to the Spectrum OTC email list

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

• Stanford Human Research Protection Policy (HRPP)


• Research Policy Handbook (RPH)
  


• Human Subjects Research Guidances

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


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

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


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


• Investigational New Drug (IND)


• Investigational Device (IDE)

Regulatory and Compliance support services provided by OTC include:

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

QuickLinks

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

• 21 CFR Part 11 compliance documentation available upon request  .

• Laboratory CLIA/CAP certificates


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


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


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


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

What is eProtocol?

eProtocol is an online application used at Stanford to submit, review, and approve research. There are four modules in eProtocol:

• IRB (Human Subjects)
• SCRO (Stem Cells)
• APLAC (Animal Subjects)
• APB (Biosafety)

eProtocol Help Desk

650 724-8964

No matter what type of human-subject research investigators may be working on, there are some steps that all should take to enhance patient recruitment. By posting studies on the following four websites, researchers can efficiently find the participants needed to complete projects in a timely fashion.

✔ REGISTER — ClinicalTrials.gov

http://clinicaltrials.gov/

Researchers may post any human-subject study to ClinicalTrials.gov — even observational studies — to benefit from a megaphone of publicity, all underwritten by the National Institutes of Health. ClinicalTrials.gov receives 50 million unique visitors a month, and its clinical trial data is regularly fed onto the Stanford Clinical Trials Directory, patient advocacy websites and the World Health Organization’s trials database, among others. The NIH has recently put more marketing muscle behind this database with the launch of a new website — www.cc.nih.gov/ — to promote clinical trial participation. (Remember that a certain class of interventional studies is required to be listed on ClinicalTrials.gov, and investigators must post these study results on the NIH site within a year after study completion.)

• Who is required to register a clinical trial with ClinicalTrials.gov?
• A Principal Investigator who holds the IND, IDE or NSR determination for a device.
• The Principal Investigator of an investigator-initiated clinical interventional study of drugs (Phases 2-4), biologics or devices, conducted at least in one site in the U.S., excluding multi-site studies where the Stanford PI is a subcontract recipient.
• For ICMJE journal publications, the Principal Investigator of an interventional study of any type, phase, or location.
• The Stanford Principal Investigator of an NIH-funded clinical intervention study of drugs (Phases 2-4), biologics or devices is responsible for registering the study (the subcontract PI is not responsible). For more information about this requirement, see http://grants.nih.gov/ClinicalTrials_fdaaa


• Failure to register with ClinicalTrials.gov
• May result in fines from NIH or FDA
• May prevent study publication


• How to register

• Register your clinical trial with ClinicalTrials.gov via a web-based data entry system called the Protocol Registration System (PRS).
• Returning users:
• Log in to PRS at http://prsinfo.clinicaltrials.gov/
• First-time users of PRS:
• You will need to obtain access to (PRS) before you can log in. One of the Stanford administrators listed below can grant you access to PRS and give you further instructions to get started.
• You can then log in to PRS at http://prsinfo.clinicaltrials.gov/to register your study.


• For information or assistance contact one of the Stanford administrators for ClinicalTrials.gov:
• Non-cancer Studies — Linda Walker  , (650) 498-6498 (Spectrum Operations, Training & Compliance)
• Cancer Clinical Trials Office — Cancer Clinical Trials Office  , (650) 724-0513

• Understand the Requirement — Helpful Links

• Clinicaltrials.gov Additional Information – PRS and U.S. Public Law 110-85
• Identifying an “ACT” (Applicable Clinical Trials)
• Identifying “Responsible Party"
• Elaboration of Definitions
• ClinicalTrial.gov Registration Policy Requirements
• Complete policy requirements
  Food and Drug Administration Amendments Act of 2007. Public Law 110-95.
• Laine C, Horton R, DeAngelis CD, et al. Clinical trial registration – looking back and moving ahead. N Engl J Med 2007;356:2734-6
• Reporting “Basic Results” in ClinicalTrials.gov (CHEST, 2009 Jul;136(1):295-303)

✔ APPROVE in CAP — Stanford Clinical Trials Directory

http://med.stanford.edu/clinicaltrials/

When you post your studies to ClinicalTrials.gov, your trials data is automatically downloaded to the Stanford Clinical Trials Directory each night. (Previously, researchers had to manually enter this data into the directory.)

Before a trial is posted to the public-view directory, the trials tool sends a notification to the lead investigator’s CAP (Community Academic Profile) inbox, in the same way that PubMed article notifications occur. At this time the researcher must approve and, if necessary, edit the imported trial description. If an investigator “accepts” a trial, it appears in both the Stanford Clinical Trials Directory and his or her public-view CAP academic webpage. In addition, researchers can manually add Stanford contact information for multicenter trials listings.

✔ ResearchMatch

https://www.researchmatch.org/

ResearchMatch is an NIH-funded resource that connects people who are trying to find research studies with researchers looking for study participants. This free matchmaking service is available for no charge to Stanford researchers because of its membership in the NIH’s Clinical and Translational Science Award consortium. For help with ResearchMatch, contact Peg Tsao, RN  

✔ REGISTER — FDA: IND and IDE Studies

http://clinicaltrials.gov/ct2/manage-recs/fdaaa

• The FDA requires registration.
• Registration must occur prior to enrollment of the first study participant.
• Failure to register applicable drug, device, or biologic studies can result in federal fines.
• Please see the ClinicalTrials.gov Protocol Registration System website.

✔ REGISTER — ICMJE (Int’l Committee of Medical Journal     Editors)

http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/

• ICMJE requires registration.
• Registration must occur prior to enrollment of the first study participant.
• Without this registration, you run the risk of not being able to publish the results of your study.
• Please see the ICMJE website for information about this requirement. » More information – ICMJE website

Should you register your research project with ClinicalTrials.gov?

1.  YES, if you want your study listed in the Stanford Clinical Trials Directory and on your CAP profile.

If you want your study to appear in the Stanford Clinical Trials Directory (v.2) then you must register your study at the NIH website, ClinicalTrials.gov. Stanford’s CT Directory only displays studies that it can pull from ClinicalTrials.gov.

2.  YES, if you want to publish the results of your study.

If you wish to publish your study in a peer-reviewed journal, then it is highly likely that that journal will expect your study to have been registered with ClinicalTrials.gov. Over 1,000 journals have adopted the policy of the International Committee of Medical Journal Editors (ICMJE) that requires registration in a publically available register. The list of journals is at this link: http://www.icmje.org/journals.html

ICMJE requires registration for a wider range of studies than what we traditionally think of as “clinical trials” at Stanford. Here is their definition. Please note that almost any prospective study of medical or health interventions in human beings qualifies, including “observational” research. http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/

“The ICMJE believes that it is important to foster a comprehensive, publicly available database of clinical trials. The ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.”

The ICMJE does not require posting of results for studies that are not otherwise required by law to do so.

3.  YES, because in some cases, IT’S THE LAW.

A smaller subset of studies are required by law to be registered with ClinicalTrials.gov. The FDA Amendments Act of 2007 (FDAAA) required that most prospective studies involving regulated drugs, biological products, and medical devices must be registered on ClinicalTrials.gov. The law also requires reporting of “basic results” and adverse events for a subset of these studies. If you would like to determine if your study is required by FDAAA to be registered, you can follow the flowchart at this link http://grants.nih.gov/ClinicalTrials_fdaaa/docs/Flow_chart-ACT_only.pdf or contact Spectrum or CCTO for assistance.

4.  When do I have to register my study?

ICMJE requires that you register prior to enrollment of your first study participant.

The law requires that a study be registered within 21 days of enrollment of the first participant. You must also update your ClinicalTrials.govrecords at least every 12 months, or within 30 days of a change in recruitment status.

5.  When do I have to post basic results?

The law requires that a subset of basic information be posted on ClinicalTrials.gov for any study in which the study product is approved for any use. For example, if you are studying an approved drug for a new use, you must register basic results. You must post this information within 12 months of the “Primary Completion Date” – defined by ClinicalTrials.gov as the final data collection point for the primary endpoint. Please note that you may not wait until complete data analysis of your project is completed to post basic results, if such completion falls outside the required time frame.

6.  What are the consequences if I don’t register?

The consequences for non-compliance can include rejection for publication in top journals (even for studies not required by law to register), fines from FDA or NIH, or the withholding of grant funds — for you individually or for the entire institution.

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

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

REQUIRED TRAINING FOR CLINICAL RESEARCH PERSONNEL

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

  More »

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

RECOMMENDED TRAINING

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

EDUCATION / WORKSHOPS

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

OTHER TRAINING RESOURCES – STANFORD

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

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

PROFESSIONAL DEVELOPMENT RESOURCES – NON-STANFORD

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

Key Points

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

RECOMMENDED TRAINING

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

EDUCATION / WORKSHOPS

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

OTHER TRAINING RESOURCES – STANFORD

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

PROFESSIONAL DEVELOPMENT RESOURCES – NON-STANFORD

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

Key Points

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

Spectrum 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.

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 goal of the Cardinal Curriculum is 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. The certification program ensures a standard level of expertise among those who support the research endeavor at Stanford University.

Cardinal Curriculum 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. Level I classes should be completed before attempting Level II classes. The ORA Training and Development Office tracks and awards certification.

Who can benefit from these classes?

Research administrators and all administrative staff who support sponsored research including:

• individuals involved with proposal preparation
• individuals who originate or approve transactions on sponsored accounts
• individuals who review or monitor expenditures on sponsored projects.

If you have questions, email or phone Lisa Teresi-Forgatsch, Office of Research Administration, at 725-9830.

The Orientation to Conducting Clinical Research at Stanford (CTR General Orientation) is a two-hour introduction and review of the clinical research process at Stanford University, designed for new clinical research personnel.

Orientation Objectives:

• Provide resources to manage and coordinate clinical research at Stanford University
• Review university departments involved in research (IRB, RMG, OSR)
• Understand key contacts, processes and documentation (maintaining a Regulatory Binder, Stanford Clinical Trials website, Hospital Ancillary Services, Epic, CTRU, HIMS)

Key Points

• Orientation assists new clinical research personnel in navigating the Stanford clinical and translation research (CTR) process.
• Orientation is offered on the second Tuesday of the month.
• Required for new employees who are working in clinical research; recommended for postdoctoral scholars and faculty.

CITI training is required human subjects training for all staff working on a research project (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting of a research project).

Stanford provides access to the required training through an interactive online tutorial, the Collaborative Institutional Training Initiative (CITI) Course in the Protection of Human Research Subjects.

CITI offers a Basic (initial) course and then a Refresher course. Training is required every three years (two years for VA).

Key Points

• CITI training is required (without exception)
• Key personnel is defined in the University Research Policy Handbook.

Epic Training is required for all Stanford Hospital and Clinics physicians and medical personnel who need access to Hospital Medical Records.

To complete the Stanford Hospital and Clinics’ Medical Staff application process, you must complete training for the Epic Clinical Information System. 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.

LPCH applicants: You may not require Epic training as LPCH is on a different electronic medical record system. If your specialty, sub-specialty and scope of clinical practice indicate that you may require access to Epic, you will have training assigned.

Key Points

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

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

Introduction to the Principles and Practice of Clinical Research

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

Principles of Clinical Pharmacology

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

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

Clinical Research Training Online Course for Principal Investigators

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

Ethical and Regulatory Aspects of Clinical Research

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

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

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

Key Points

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

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

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

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

Useful Links

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

Education and Training

Stanford Courses

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

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

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.

The roles and responsibilities of School of Medicine organizational units, institutional officials and key individuals in the areas of grant compliance and institutional oversight are summarized below.

The Research Management Group website provides more detailed information.

Research Management Group

Research Management Group (RMG) serves as the central resource and expert partner on research administration, providing support and oversight of sponsored projects.

RMG represents Stanford University as the institutional official for proposal submission and award acceptance.

Work with your Research Process Manager (RPM)

Research Process Managers (RPMs)

The Research Process Managers (RPMs) in RMG are the primary point of contact for sponsors and Department/Institute grant and contract administrators. RPMs are the University’s sponsored projects institutional representatives for School of Medicine faculty. RPMs are assigned to each division in the Department of Medicine and School of Medicine Institutes. » RPM Assignments

Partnering with faculty and staff, RPMs

• direct and manage the proposal process to ensure timely, compliant and accurate submissions
• develop budgets for all proposals with the PI
• accept and negotiate grant awards on behalf of the University
• provide expert consultation and oversight to ensure that sponsored research funds are managed and expended in compliance with internal and external policies
• continue as the institutional representative throughout the life of the award

Office of Sponsored Research (OSR) Accounting

OSR Accounting performs post award activities, including

• account set-up review, billing, and reviewing cost transfers for compliance with University and sponsor policies
• preparation of interim and final reports for various University sponsors
• ensuring compliance with University and sponsor policies

Office of Sponsored Research (OSR) Contracts

OSR Contract and Grant Officers (School of Medicine Team) are responsible for:

• formal negotiation and administration of extramural support for University contract agreements sponsored by government and non-government sponsors (sponsored research) including Clinical Trials.
• preparing, negotiating and overseeing subawards issued to subrecipients under Stanford sponsored projects awards
• advising and assisting Stanford administrators, principal investigators, and staff members
• interpreting and explaining contract terms and conditions
• ongoing management of contracts and subawards
• assisting in the resolution of problems that develop in the course of projects by consulting with the investigator(s), staff, and sponsors

Office of Research Administration (ORA) Accounts Receivable

ORA Accounts Receivable is responsible for

• billing, receipts and collections for all sponsored (government and non-government) awards in the university
• collection of research funds

Industrial Contracts Office (ICO)

ICO is responsible for:

• negotiating and signing sponsored research, collaboration, and material transfer agreements with industry (except for clinical trial agreements, which are handled by the Office of Sponsored Research).

ROLES & RESPONSIBILITIES — ADMINISTRATIVE PROCESS INITIATION

PI and/or Study Coordinator

• Prepares IRB submission
• Negotiates consent form with sponsor
• IRB notifies RMG of submission.
• PI resolves conflicts of interest if necessary, responds to IRB.

RMG

• Receives notification from IRB of application submission or from PI of new study.
• Obtains copies of IRB application as needed.
• Reviews study protocol and informed consent to be sure study qualifies for CT F&A (Facilities and Administrative Cost Rates), and to determine if a contract is necessary.

What is Parallel Processing?

Parallel Processing (PP) is the process that supports simultaneous budget development and negotiation, contract negotiation, and IRB review in order to expedite commencement of a study.

RMG will coordinate with the OSR contract office once they receive documents (study protocol, etc.) for a new study from the IRB or the PI. This allows RMG, OSR, and the IRB to begin their review and negotiation processes in parallel, rather than sequentially.

PI and/or Study Coordinator

• Forwards sponsor payment schedule and contact information to RMG.
• Downloads and completes CTRP Workbook, available on the Spectrum website through Study Navigator, separating standard of care (covered by insurance) versus research costs (paid by the sponsor and included in the study budget).
• Supplies contact information and draft contract to OSR.

RMG

• Establishes initial institutional record for the study and tracks its status until awarded.
• Sends acknowledgement to PI of receipt of study information/application and notifies PI of missing requirements needed to commence budgeting; acknowledgment will also provide the name of the CT RPM who will work with the PI, and the SPO #, the unique institutional designation for every sponsored project.
• Notifies OSR Contracts of new study

OSR Contracts

• Receives study notification from RMG. Obtains minimum required items from sponsor or PI to begin contract negotiations: 1) draft contract; (2) draft protocol; and (3) PI name.
• Creates log to track status and notifies PI of assigned Contract Officer.
• Begins contract negotiations.
• Communicates with PI or study coordinator as needed regarding contract terms and conditions.

Spectrum

• As needed, consults with RMG or OSR and/or study coordinators on clinical procedures, pricing, regulatory issues, hospital requirements, and clinical and/or operational aspects of the study.

ROLES AND RESPONSIBILITIES — PRE-STUDY START-UP

PI and/or Study Coordinator:

• Coordinates submission of FDA 1572 form
• Signs confidentiality agreements (PI)
• Participates in Investigator/start-up meeting
• Receives protocol from sponsor
• Assesses study feasibility – staff, facilities, etc.
• For PI-initiated studies, consults with RMG to create a budget proposal to submit to an industry sponsor
• For PI-initiated studies, works through Spectrum Study Navigator to obtain services as needed

RMG

• As needed, advises on feasibility or other requests
• May prepare a feasibility budget prior to IRB submission, if requested by the PI/coordinator
• For PI-initiated studies, develops budget and reviews proposal for submission

OSR Contracts

• As needed, advises on confidentiality agreements
• OSR will sign off as institutional representative, if required by the sponsor

Spectrum

• As needed, offers training and advice on study start-up, IRB preparation, hospital contacts, sponsor interactions.
• Conducts Coordinator orientation.
• For PI-initiated studies, provides biostatistical, informatics, and ethics consultations.

Roles & Responsibilities — Budgeting

PI and/or Study Coordinator

• Determines study eligibility for Medicare NCD.
• Identifies patient care costs in the study that are routine care versus research costs to be paid by the sponsor.
• Completes Clinical & Translational Research Planning Workbook (CTRP Workbook).
• Determines the level of effort required for study personnel to execute a study.
• Identifies the locations where the research related items will be performed.
• If study qualifies under NCD, works with CT RPM to determine if any research costs can be billed to insurance.
• Consults with hospital ancillary services experts to correctly analyze feasibility, identify protocol required procedures and to schedule study subjects with hospital specialty areas.
• For procedures that are not included on the CTRP workbook, provides CPT codes for research related procedures.
• May need to provide patient information for unusual or complex procedures in order to obtain billing reports.
• Department DFA participates in approvals of unusual circumstances.
• For device studies, prepares Medicare FI preauthorization packet for submission to Patient Financial Services.

Spectrum OTC (Operations, Training & Compliance)

• Provides budget/billing training, advises on hospital or regulatory issues as needed.
• Coordinates RAC review of studies with issues related to hospital billing or adverse event.
• Tracks submission of Medicare Pre-authorization requests to Patient Financial Services (PFS).

Research Management Group (RMG)

• Reads protocol, IRB application, consent.
• Reviews sponsor payment schedule and contract.
• Meets with PI/Study Coordinator to evaluate protocol, obtain budget information, and review payment terms.
• Provides guidance on NCD determination and whether research costs can be billed to insurance.
• Compares CTRP Workbook vs consent vs payment schedule vs protocol to ensure consistency.
• Acquires prices from available databases or Hospital Departments.
• Creates budget, revises as needed, and obtains PI approval.
• Consults with OSR, IRB, Hospital, Spectrum OTC, PFS as needed.
• Obtains Hospital approval for device studies.
• Negotiates budget and payment terms with sponsor.
• Obtains waivers as needed.
• Obtains Medicare FI approval prior to completing budget.
• Revises payment schedule to match approved and negotiated budget.
• For PI-initiated studies, RMG prepares budget and obtains approvals prior to submission of proposal to the funding agency.
• Revises internal budget as needed to match sponsor award.

Hospital

• Provides technical assistance in determining appropriate codes for tests/procedures.
• Establishes discounts for research prices.
• Provides pricing information as needed.
• Submits Medicare Pre-authorization requests to the Fiscal Intermediary.

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.