Operations, Training and Compliance

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

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

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

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

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

OTC Roles

Overview of OTC Services

Study Facilitator Services

Budgeting and Billing Support

Regulatory and Compliance Support

Education and Training Opportunities

Community Research Inquiries

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?

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.

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.

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.

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

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

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

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

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

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

RPAC's mission is to:

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

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

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

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.

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

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

What is an Electronic Medical Record (EMR)?

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

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

Epic (for SHC Electronic Medical Records)

What is Epic?

How to Get Access to Epic

Is Epic Part 11 Compliant?

SHC Epic-Support

Do I need IRB approval to review Electronic Medical Records?

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

How do I contact the Medical Record Department?

Epic (for LPCH Electronic Medical Records)

LPCH Epic Access

LPCH Epic – Support

21 Part 11 Compliance Document

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

REQUIREMENT!

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

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

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

REQUIREMENT!

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

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

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

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

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

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

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

• Policies
• Stanford Industry Interactions Policy
• Annual Outside Professional Activities Certification
• Ad-hoc Disclosure Procedures
• Tips for Avoiding Conflicts of Commitment & Interest

Key Points

• Disclosure of conflicts of commitment and interests is REQUIRED under University, as well as School of Medicine policy.

• 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
  
  

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.

• 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)

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.

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.

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.

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

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

Additional Resources

• Environmental Health & Safety

Key Points

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

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

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

Key Points

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

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.

This applies if you are a SoM (non-faculty) employee or postdoc who: 1) may be assigned duties with potential for occupational health exposures related to clinical research participants and 2) performs job duties (including Epic access) within SHC, LPCH, and/or other Stanford affiliated research patient care locations. For staff who will participate in any clinical trials/research study, you are required to complete health screening, safety and compliance training administered by Environmental Health & Safety (EH&S) and Stanford University Medical Center (SUMC) HealthStream.

Supervisors start here: Clinical Researchers Occupational Exposures Assessment Questionnaire

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

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

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.

This applies if you are a SoM (non-faculty) employee or postdoc who: 1) may be assigned duties with potential for occupational health exposures related to clinical research participants and 2) performs job duties (including Epic access) within SHC, LPCH, and/or other Stanford affiliated research patient care locations. For staff who will participate in any clinical trials/research study, you are required to complete health screening, safety and compliance training administered by Environmental Health & Safety (EH&S) and Stanford University Medical Center (SUMC) HealthStream.

School of Medicine Clinical Research Staff and PostDocs are responsible for:

• Completing health-screening requirements with Stanford University Occupational Health Center
• Completing the appropriate safety and compliance training with Environmental Health & Safety AND online modules with SUMC HealthStream
• Completing the General Orientation, and Budgeting and Billing Training

EH&S/Occ Health Fee Schedule

HealthStream Orientation and FAQs

Register for Spectrum Training

Memos, Updates, and Reminders

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

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

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

Click on any of the headings below for detailed information.

Background

Attending ICCR

Upcoming Course Dates

Prerequisite Reading

Modules

View Past Courses

ICCR Mentors

Testimonials

Key Points

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

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

Orientation Objectives:

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

Key Points

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

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

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

REQUIRED TRAINING FOR CLINICAL RESEARCH FACULTY

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

RECOMMENDED TRAINING

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

EDUCATION / WORKSHOPS

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

MENTORING

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

OTHER TRAINING RESOURCES – STANFORD

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

PROFESSIONAL DEVELOPMENT RESOURCES – NON-STANFORD

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

Key Points

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

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

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

REQUIRED TRAINING FOR CLINICAL RESEARCH PERSONNEL

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

  More »

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

RECOMMENDED TRAINING

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

EDUCATION / WORKSHOPS

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

OTHER TRAINING RESOURCES – STANFORD

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

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

PROFESSIONAL DEVELOPMENT RESOURCES – NON-STANFORD

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

Key Points

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

RECOMMENDED TRAINING

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

EDUCATION / WORKSHOPS

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

OTHER TRAINING RESOURCES – STANFORD

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

PROFESSIONAL DEVELOPMENT RESOURCES – NON-STANFORD

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

Key Points

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

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

• Investigational New Drug (IND) Application Template

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.

IDE Templates

• Investigational Device Exemption (IDE) Application Template
• Investigator Agreement Template

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

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

Mobile Medical Application Resources

• FDA Mobile Medical Applications Information Page
• Email your MMA question directly to FDA
• FDA Guidance “Mobile Medical Applications” (2015)
• Stanford Biodesign MMA Roadshow (archived slides and audio)
  (slides)
  (audio)
• mHealth Regulatory Coalition

Training

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

Medicare IDE Preauthorization Packet

• ALERT! 2015 Changes to Medicare IDE Preauthorization
• Quick guide
• Checklist
• Cover letter