Clinical Research You are NOT alone Shirley L

Clinical Research You are NOT alone! Shirley L. T. Helm, MS, CCRP Manager of Clinical Research Administration shirley. helm@vcuhealth. org; 628 -2942 Joelle Lemmons, RN, BSN, MS Nurse Manager, CRU joelle. lemmons@vcuhealth. org; 628 -4756 Alanda Perry Jones, MA, CCRP Clinical Trial Specialist perryar@vcu. edu; 628 -9395 Art Carpenter Senior Financial Analyst ajcarpenter@vcu. edu; 828 -8237

Presentation Content • • NIH Definitions- new policies regarding clinical trials CCTR Innovator CRS Resources and Services: The Who, Where, What and How Clinical Research & CRS: Policies, Procedures, Processes Ø Accessing CRS Resources & Services- Art Carpenter, CRS Senior Financial Analyst Ø Initiatives • Institutional Information Ø Ø Ø Collaborative IRB Training Initiative (CITI) On. Core: Clinical Research Management System (CRMS) Study Finder WIKI pages Checklists: Alanda Perry Jones, CRS • VCU Health Information & Updates Ø Joelle Lemmons, CRU Nurse Manager, RN, MS

Definition of Clinical Research conducted with human subjects or on material of human origins, including tissues, specimens and cognitive phenomena for which an investigator directly interacts with human subjects. Examples include mechanisms of human disease, observational studies involving therapeutic interventions, epidemiological and behavioral studies, outcomes research, and health services research. NIH Definition of a Clinical Trial A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health related biomedical or behavioral outcomes.

Clinical Trial • New NIH clinical trial policies apply to social & behavioral trials (released September 2016) ØPolicies span grant submission through dissemination of results ØGCP required- Jan. 1, 2017 ØSingle IRB for Multi-site Studies- May 25, 2017 ØSpecific Funding Opportunity Announcement (FOA)- Sept. 27, 2017 ØInformation & References: ü OBSSR Connector Blog ü Case Studies ü http: //jamanetwork. com/journals/jama/fullarticle/2553888

Clinical Trial A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health related biomedical or behavioral outcomes. • Research and Human Subjects: (45 CFR 46. 102(d) and (f)) Per Common Rule ØSystematic investigation, includes research development, testing & evaluation, designed to develop or contribute to generalizable knowledge ØLiving individual from which research obtains – Data through intervention or interaction with individual – Identifiable private information

Clinical Trial • Prospective Ø Pre-defined process that assigns research participants to one or more “arms” of an intervention, placebo, other control • Intervention Ø Manipulations (participant and/or environment) for the purpose of modifying one or more health-related biomedical or behavioral processes/endpoints ü Includes diet, cognitive therapy, exercise, prevention & treatment strategies among others • Interaction Ø Includes communication or interpersonal contact • Private Information Ø Includes information regarding behavior ü Reasonable expectations that information will not be made public (EMR, observation, recording) ü Must be individually identifiable or may readily be ascertained with associated information • Health related biomedical or behavioral outcomes Ø Pre-specified goal(s) or conditions(s) reflect the effect of one or more interventions on participant biomedical or behavioral status or quality of life

C. Kenneth & Diane Wright Center for Clinical & Translational Research • VCU institutional name for the NIH Clinical & Translational Science Award • Executive Director: Dr. F. Gerald Moeller • Umbrella Center for “hubs” – – – Clinical Research Services Research Innovator Scientific Review Committee – Mid-Atlantic Twin Registry – Education Informatics Community Engagement

http: //www. cctr. vcu. edu/index. html

CCTR Innovator Research Liaison: Pam Dillon, Pharm. D. pmdillon@vcu. edu • Conduct mock study sections • Assist in matching collaborators • Initial study consult ØDevelopment of research idea ØFunding opportunities: Internal and External ü CCTR Endowment Fund: 4 opportunities/year (Feb. 1, 2017) § $50, 000 over 18 months for single investigator § $130, 000 over 2 years for multi-school research ØAssist with initial FDA applications

CCTR Innovator Grant Writer: Bonnie Quearry bjquearry@vcu. edu • Provides consults in structure & writing of research strategy for grants, foundation applications • Request priorities based on funding amount, center/institutes, PI and students as requests allow • Earlier consultations and requests are encouraged

CCTR Innovator Biostatistician: Adam Sima, Ph. D adam. sima@vcuhealth. org • Assists with determination of appropriate experimental design • Assists with development of appropriate sample size, analysis plans, randomization and stratification procedures • Provides interim & final analysis • Grant application assistance • Request priorities based on funding amount, center/institutes, PI and students as requests allow • Earlier consultations and requests are encouraged • Additional Resource: Biostatistical Consulting Laboratorystudent led: http: //www. biostatistics. vcu. edu/bcl/

Clinical Research Services Structure • The C. Kenneth and Dianne Wright Center for Clinical and Translational Research (CCTR) is the parent center of the CRS • CRS Resources and Services are comprised of: • Financial Services • Regulatory Services • Clinical Services (Nursing, Bionutrition and Unit) • CRS Director of Business Operations: Lydia Klinger, CRA • CRS Medical Director- Clinical Services: Antonio Abbate, MD • CRS is an Ancillary Service and the VCUHS charge-master rates apply as with Radiology, Pathology, and other Ancillary Services.

CRS Resources and Services: Whom do we serve? • K Scholars & Junior Investigators Ø support & education for clinical research • Senior Investigators Ø specific research study needs (e. g. Clinical Coordinators, Budget Development, Regulatory, Clinical Research Unit Services) • All Investigators/Study Teams Ø Ongoing support and education • VCU Institutional Clinical Research Infrastructure Ø Ø Office of the Vice President of Research and Innovation (OVPRI) Office of Sponsored Programs (OSP) Institutional Review Board (IRB) Schools and Departments

CRS Regulatory Office Who we are: crsadmin@vcu. edu; 628 -2942 Shirley Helm, MS, CCRP Manager of Clinical Research Administration Debbie Bailey, RN Regulatory Compliance Coordinator Terre Williams, Regulatory Compliance Manager Where we are: Richmond Academy of Medicine 1200 East Clay St.

CRS Regulatory Services What are our services? • Initial Regulatory Document Preparation and Sponsor Submission Ø Submission of complete sponsor packet to CRS is required to initiate services Ø Form 1572 -Statement of Investigator Ø Financial Disclosure Forms • Initial Informed Consent Preparation • Initial RAMS-IRB Submission for All Research Ø Industry sponsored Ø Non- industry sponsored Ø Investigator Initiated • Initial Western IRB(WIRB) Submission

CRS Financial Office Who we are: crsbudgets@vcu. edu; 628 -3221 Sara Twombly, MACI, CCRC, CRS Program Manager John Thrift, MBA Billing Compliance Manager Alanda Perry Jones, MA, CCRP Clinical Trials Specialist Christopher James, LCSW Budget & Coverage Analysis Specialist Where we are: Richmond Academy of Medicine 1200 East Clay St.

CRS Financial Office What are our services? Our primary expertise is Industry-Sponsored Research Budget Development and Negotiations • • • Budget Development & Negotiation Ancillary Service Set Up Internal Documentation, Preparation & Review RAMS-SPOT Submission Medicare Administrative Contractor Submissions Protocol Amendment Review & Negotiation Re-Negotiation of Screen Failure Rate Post-Contract Execution Budget Re-Negotiation Cost Coverage Analysis Preparation Budget Preparation Assistance: NIH & Industry Sponsored Investigator Initiated

CRS Financial Services What to expect: • Evaluation of protocol and all applicable documents • Preliminary Items Developed for Study Team Review Ø Study Team Effort Estimation Time Grids, Ø Per Visit Cost Summary Ø Preliminary Internal Budget • • Initial proposal generated for appropriate study team/departmental reviews CRS Financial Office conducts all further negotiations until the best offer is on the table Ø NOTE: All sponsor inquiries should be directed to the CRS. If at any point the PI/Study team is contacted with regards to budgetary concerns from the sponsor/CRO, it is requested that any communication be directed to the appropriate CRS budgeting staff member. • • Final budget sent to the PI/Department for review and approval Upon final approval of the budget, CRS Financial Office will route paperwork according to requested services (RAMS-SPOT)

CRS Clinical Services Who we are: clinical. research@vcuhealth. org • Joelle Lemmons, RN, BSN, MS, Nurse Manager Ø joelle. lemmons@vcuhealth. org Ø 804 -628 -4756 • Yvonne Reyes, RN, MS, CCRP, Nurse Clinician Ø yvonne. reyes@vcuhealth. org Ø 804 -828 -4815 • Sakita Sistrun, RD, MS, CCRP; Bionutrition Manager Ø sakita. sistrun@vcuhealth. org Ø 804 -828 -9226

CRS Clinical Research Unit Services What are our services (facilities and space)? • North 8 facilities Ø Ø Ø Ø Ø 1 Check-in Room 2 Phlebotomy Chairs 8 In-Patient Beds 1 Ultrasound Room 3 Exam Rooms Interview Room Exercise Testing Room Conference Room Metabolic Chamber & Suite Infusion Room (4 Chairs)

CRS Clinical Research Unit Services What are our services (professional staff)? • Nursing staff Ø 9 RN, 2 LPN, Care Partner Ø Specially trained in care of research participants Ø Phlebotomy, IV therapy, Chemotherapy, Telemetry Ø Emergency resuscitation, life sustaining techniques Ø Research education • Bionutrition staff Ø Protocol Consultation Ø Diet Development Ø Body composition measurement & analysis Ø Diet analysis Ø Nutrition Data System (NDS) Ø Meal & snack preparation & delivery

Requesting CRS Resources & Services • Study teams requesting ancillary services (includes CRS) will complete the two step Red. CAP Ancillary Request Form process located at: http: //go. vcu. edu/ancillaryrequest • Step 1: General study information is entered, including study specific documents, click “submit” • Step 2: An email notification will be sent to the “requester” for each selected Ancillary Service – Click on the link provided in the email and complete specific Ancillary Service Red. CAP form and submit

Step 1: Ancillary Request Form

Step 1: Ancillary Request Form

Step 2: CRS Request Form

CRS Initiatives • Workforce Development • Coordinator Council • Coordinator Career Ladder Development • Education • Host So. CRA certification exam and work study groups • Process Improvement - partner & collaborate with • • • VCU Health-Mary Harmon, Ph. D, Director of Clinical Research Office of the Vice-President for Research and Innovation (OVPRI) Office of Sponsored Programs (OSP) Institutional Review Board (IRB) Schools and Centers

VCU Institutional Information Collaborative IRB Training Initiative (CITI) • Fulfills the Federal Mandate training requirements for Researchers involved in human subjects research (GCP) • Web based, Modular Design Ø Basic Human Subjects Protection - Initial (one of the following modules) ü Social and Behavioral Research ü Biomedical Research Ø Refresher Human Subjects Protection - (following initial, every two years) Ø Good Clinical Practice (GCP) - Basic Course, every 3 years Ø Coordinator: Recommended for those with this role www. citiprogram. org

VCU Institutional Information On. Core: Clinical Research Management System Web-based; accessible from work, off-site Role based security; HIPAA compliant Central Database School and Departmental Metric Reporting Ø Activation and Enrollment Metrics Ø Number of studies by PI, diagnosis/disease and more • Participant Safety: Integration with Cerner • Billing Compliance and Sponsor Invoicing • Electronic Case Report Forms (e. CRFs) • • Information: go. vcu. edu/wiki Email: oncore@vcu. edu

VCU Institutional Information On. Core: Clinical Research Management System • Draft On. Core VCU Compliance Notice includes Required Use for: Ø All Clinical Trials Ø All Clinical Research for which one or more applies: Involves prospective use of VCUH clinical services/resources Listed on clinicaltrials. gov Corporate supported Faculty held Investigational New Drug (IND) or Investigational Device Exemption (IDE) ü Approved via Full Board procedures of responsible IRB ü ü

VCU Institutional Information Study Finder • VCU Clinical Trials: pulls studies from clinicaltrials. gov for VCU specific enrolling studies From VCU website. Research/Center for Clinical & Translational Research From VCU Health & My VCU Health website- Health Information

Clinical Research Information • Enter e. ID • All CRS policies, pricing, standard operating procedures • Institutional requirement information • All CRS Clinical Research related activities go. vcu. edu/ccra

CCRA Wiki Pages- Home

Clinical Research Pre-Award Forms Office of Research and Innovation http: //www. research. vcu. edu/forms/index. htm#osp_forms

Clinical Research Pre-Award Forms Office of Research and Innovation http: //www. research. vcu. edu/forms/index. htm#osp_forms

Clinical Research Pre-Award Forms Compliance Document Checklist

Clinical Research Pre-Award Forms Coverage Analysis Forms

Clinical. Trials. gov Account Creation

Clinical. Trials. gov • Responsible Party and Applicable Trial • Why do you need to register and report results? Ø It’s the law-FDAAA 801 (fines could apply) Ø Publication (ICJME) Ø Funding Ø Medicare billing compliance • Registration & Results reporting guidelines: https: //clinicaltrials. gov/ct 2/manage-recs/fdaaa

Patient Safety, Quality & Service ü Star Service Behaviors • Consent • Team Members • Financials • Inpatient Units/Clinics TJC Research Coordinators August 24, 2016 40

VCU Health Policies • • • PC. CP. 004 Research in Patient Care Areas HR. SC. 007 Dress Code HR. SC. 003 Star Service Expectation HR. SC. 001 Standards of Conduct & Performance LD. AD. 004 Cell Phones and Personal Computing Device use in Patient Care Areas HS. IM. PO 1504 Internet Access and Usage HR. EM. 004 Terms of Employment HS. IM. PO. 1522 Personal Mobile Device Acceptable Use Policy EC. FM. 002 Posting of Materials TJC Research Coordinator August 24, 2016 41

Thank you!! Shirley L. T. Helm, MS, CCRP Manager of Clinical Research Administration shirley. helm@vcuhealth. org; 628 -2942 Joelle Lemmons, RN, BSN, MS Nurse Manager, CRU joelle. lemmons@vcuhealth. org Alanda Perry Jones, MA, CCRP Clinical Trial Specialist perryar@vcu. edu; 628 -9395 Art Carpenter Senior Financial Analyst ajcarpenter@vcu. edu; 828 -8237