1. HealthStream Training for Postdoctoral Scholars involved in Clinical Research Linda S. Walker, Program Administrator Jessica P. Meyer, MBA, Program Coordinator June 2010 1 Spectrum Stanford Center for Clinical and Translational Education and Research

2. Who is Spectrum? Spectrum is the Stanford Center for Clinical and Translational Education and Research Spectrum Operations, Training and Compliance is the single point of contact for clinical research issues Our mission is to: ◦ Align organizational “service” based activities ◦ Provide education, training and mentoring to clinical research personnel ◦ Develop an integrated research infrastructure 2

3. What is HealthStream Training? HealthStream Training is a joint effort of Spectrum Operations, Training and Compliance and the Postdoctoral Affairs Office, in collaboration with Lucile Packard Children's Hospital (LPCH) and Stanford Hospital and Clinics (SHC) HealthStream Training is mandatory for all non-faculty School of Medicine (SoM) clinical research personnel, involved with human subject research and data (clinical trials) 3

4. What is HealthStream Training? Goals of HealthStream Training ◦ Protect the health and safety of Stanford University clinical research personnel who work with patients, clinical trial volunteers and/or protected health information (PHI) ◦ Provide information and training to equip staff to perform patient care duties within SoM departments, at LPCH, SHC, VA Palo Alto Health Care System (VAPAHCS) and satellite facilities HealthStream Training is completed through and e-Learning management tool: HealthStream Learning Center™(HLC) 4

5. Involved in Clinical Research? Do you (or will you in the next 12 months): Have in person, face-to-face contact with research participants? Handle research patient samples including blood products, tissue or fluids? Have access to PHI (protected health information) through enrollment, billing, phone screening, data analysis, etc.? Is your office and or the place where you conduct your research located in SHC/LPCH or one of the clinics? 5

6. PostDoc HealthStream Training Process Step 1: PostDoc completes online form ◦ https://med.stanford.edu/survey/postdochealthstreamform https://med.stanford.edu/survey/postdochealthstreamform Step 2: Spectrum receives results  Determines eligibility  Creates profile in HealthStream™ Learning Center (HLC)  Sends course assignments to “students”  Students have 30 days to complete training Step 3: Spectrum audits completion status  Spectrum audits students profiles monthly  Spectrum send “Out of Compliance” notices to SSA and Alistair Murray for incomplete courses 6 http://postdocs.stanford.edu

7. 7 PostDoc completes HealthStream Assessment Form Spectrum receives data from Assessment Form PostDoc applicable ? Spectrum sends non-applicability email Spectrum creates HealthStream profile, assigns courses, emails instructions PostDoc has 30 days to complete assigned HLC modules Spectrum audits PostDoc profiles Assignment complete? Spectrum sends non- compliance notice to Student Services Administrator & Alistair Murray Audit complete NO YES PostDoc HealthStream Training Process http://postdocs.stanford.edu Compliance Audit YES NO

8. 8 1.Code of Conduct (includes Deficit Reduction Act) 2.Standard Precautions: Bloodborne Pathogens and Other Potentially Infectious Materials 3.Prevention of Healthcare-Associated Influenza- Infection Control 4.Quality Improvement 5.Patient Rights 6.Safety Reporting- Patient Safety Net 7.Electrical Safety 8.Emergency Preparedness 9.Fire Safety Awareness and Response 10.Confidentiality Statement 11.Service Excellence (SHC or LPCH) 12.National Patient Safety Goals 13.Respiratory Therapy 14.Cultural Diversity – Sexual Harassment 15.Prevention of Hospital Acquired Infections *Some of these courses have Pre-Assessment Tests* HealthStream Training Modules

9. Additional Clinical Research Training Additional Training may be required: ◦ CITI Training (Human Subject Research Protection) from the IRB ◦ eProtocol Training from the IRB ◦ See Training Advisor from EH&S ◦ Biohazardous Material Training from EH&S Also recommended are the Spectrum Orientations ◦ General Orientation: How to conduct clinical research at Stanford ◦ Budgeting and Billing: How to budget a study and how the billing system works at Stanford ◦ Please see the Education Calendar for dates and to register http://spctrm.stanford.edu/training_html http://spctrm.stanford.edu/training_html 9 Please see Clinical Research Personnel Training Checklist (PostDocs)

10. Clinical & Translational Research Resources Cancer Center http://cancer.stanford.eduhttp://cancer.stanford.edu Research Compliance Office http://humansubjects.stanford.eduhttp://humansubjects.stanford.edu Environmental Health & Safety http://med.stanford.edu/somsafety/training.html http://med.stanford.edu/somsafety/training.html Spectrum, The Stanford Center for Clinical and Translational Education and Research http://spectrum.stanford.edu (site under construction)http://spectrum.stanford.edu ◦ Spectrum | Child Health http://spectrumchildhealth.stanford.eduhttp://spectrumchildhealth.stanford.edu ◦ Spectrum | Operations, Training and Compliance http://spctrm.stanford.edu Email :clinicaltrials@med.stanford.eduhttp://spctrm.stanford.educlinicaltrials@med.stanford.edu ◦ Services: CTR Planning; Biostatistics Consultation; Education and Training; Help Desk/Facilitator Services; Research Coordinator Services; Regulatory and Compliance Consultation; CTR Management Tools and Services; Websites 10 Please see Clinical Research Personnel Training Checklist (PostDocs)