Q1 Research Operations Quarterly Meeting January 19, 2021

Q1 Research Operations Quarterly Meeting January 19, 2021 Research Operations

Research Operations New Team Members Pre-Award, Grants & Contracts ̶ Gina Daniels (Dec 2019) ̶ Deb Melnikas (Feb 2020) ̶ Kathy Donnelly (Mar 2020) ̶ Shaniel Walker (May 2020) ̶ Kellye Lymon (Dec 2020) 2

InfoEd Updates InfoEd ̶ New format (ie. search feature, look up BU/IOs) ̶ Central repository ie. subawards, invoices, etc ̶ Award set-up with Pre-Award team 3

Agreements, Federal Updates, and Commitment Transparency Efforts January 19, 2021 Research Operations

Research Vendor Vetting & Service Agreements Issue: Many requests to use a variety of digital tool vendors for research coming in primarily through Privacy. Ongoing Efforts: ̶ Who: BMC Research Operations is currently in discussion with Privacy, Legal, Supply Chain Operations (SCO), IT, and IS representatives ̶ What: streamlined process for vetting and onboarding vendors for research purposes. Process for research-centric requests will follow the general SCO process with nuances built in to respond for research-specific issues Deliverables in Development: ̶ Intake Analysis and Work Flow Diagram: Determines resolution path depending on whether or not the tool will be used for research, clinical purposes or mix of both ̶ Intake Checklist/Cover Page of Questions: Mirroring SCO Developing a list of general questions requestors answer to initiate vetting research vendors. 5

Commitment Transparency: BMC Disclosure Infrastructure COI Smart Survey BMC Commitment Transparency Submitted annually Contact the Compliance Dept. for questions or updates. Other Support & Foreign Component Disclosures Investigator Updates Required for all NIH awards Contact Research Operations for questions or updates. Should new interests/support arise you must promptly update the COI Compliance office and, if applicable, the NIH via Research Operations. 6

OTHER SUPPORT & FOREIGN COMPONENT PACKAGE INITIATIVE AND PACKAGE – LAUNCHED 12/2020 Scope & Purpose: Informing the BMC research community about NIH requirements to fully disclose Other Support and Foreign Components for NIH awards. Contents: ̶ Fundamental Guidance on Other Support & Foreign Component ̶ Flow Chart for Handling Other Support & Foreign Component ̶ Infographic — Other Support, What’s Different? ̶ Cheat Sheet Desk Reference — Do I have an Issue, and What Do I Do? ̶ Case Studies for Other Support and Foreign Influence Issues ̶ Other Support Sample Page ̶ Slide Deck on Other Support and Foreign Influence: Education and Training ̶ Email Informing Research Community of the issues and this package 8

Where to Find These Resources Research Operations Website on the Hub: find the Foreign Influence / Commitment Transparency materials and the Other Support materials. 9

Related Efforts: Travel and Transferring BMC Data or Biological Materials Scope: The guidance and resources Research Operations developed is relevant for any current or departing BMC researchers. Purpose: Responds to local trends at Boston research institutions greater federal oversight at airports of researchers travelling internationally. ̶ Provides general reminder about BMC requirements for transferring/sharing ANY BMC data or biological materials ̶ Provides new guidance, process, and documents for researchers travelling outside of the United States for their research. Contents: ̶ Guidance on Travel and Transferring BMC Data ̶ Guidance on Travel and Transferring BMC Biological Materials ̶ BMC Template Authorization Letter Permitting Travel with BMC Data ̶ Instructions for Completing Authorization Letter 10

Where to Find These Resources Research Operations Website on the Hub – Click on the Training and Education Icon, choose “Resources” in the drop down menu, and look for the Travel and Transferring Data/Biological Materials section in the alphabetized list 11

BMC Policies and Procedures Updates Research Operations, engaging outside consulting company Huron, is spearheading efforts to review, revise, and in some cases create updated policies. Why? ̶ Responding to federal legal and regulatory changes ̶ Clarify policies for better comprehension and compliance ̶ Undergird and support related commitment transparency efforts Policies in Process Conflict of Interest Conflict of Commitment Material Transfer Agreements Export Control Subaward Agreements Proposal Submission Subrecipient Risk Assessment/Monitoring Time and Effort Cost Share Recharge Centers F&A Space Management Program Income Account Setup Account Closeout Fund Monitoring Sponsored Project Billing Research Misconduct Intellectual Property CDAs/NDAs 12

What’s Next? Training and Education: ̶ Forthcoming in 2021 ̶ Research Operations in coordination with Compliance ̶ Communications will be sent out once training schedules and plans are finalized ̶ Materials will also be uploaded on the Research Operations website 13

The End Questions? Contact us for assistance on any of these topics or related issues ̶ Director of Pre-Award Grants and Contracts, Stephanie Wasserman: Email: [email protected] ̶ Senior Research Compliance Manager, Michelle Irick: Email: [email protected] 14

Research IS Program Introduction 15

The Research IS Program was created to support IT innovation among the BMC research community Partners with the research community to create a culture of innovation ̶ Supports the collaborative information technology and research community partnership ̶ Advocates for the technology needs of the research community Promotes data security, compliance, and privacy Develops strong relationships with vendors Encourages research goals to be aligned with hospital strategic goals 16

Organization Chart 17

Research IT prioritization is siloed from clinical, but aligned with overall BMC strategy and mission and integrated with Research Operations 18

Program will support researchers with IT scope, planning, budgeting and implementation of technology to support research studies Provide guidance on available software Identify feasibility of proposed solution by consulting with internal IT leadership and outside vendors Identify IT budget required for research study: ̶ Including (not limited to): hardware, software, equipment, resources, maintenance plan Hire/manage IT consultants ̶ Important for us to have a reasonable budget identified in pre-award to support the hiring of consultants Project manage and oversee Research IS projects Manage research computing equipment purchases and procurement process 19

Program will support a variety of research IS needs Technology to be used at Boston Medical Center or to further the care of BMC patients Technology used to gather data from Boston Medical Center patients Software integrating with existing software hosted by Boston Medical Center 20

Requests for support from the program can be in furtherance of either assessment and/or implementation of technologies Request Type Assessment Stage Deliverables Pre-award/ 1. Complete Assessment Document Grant writing 2. Security Review 3. Resource Allocation 4. IT Budget Implementation Post Award 1. Resource assignment 2. Hire & manage consultant (*dependent on project deliverables) 3. Project management & implementation of project 21

Submissions to the Program should be pursued early in the proposal generation process Submit your request for review as early as possible IT review should begin as soon as you start working with Development, Research Ops and/or the IRB Allow time for the following tasks to be complete: ̶ Discuss with internal IT teams to understand resources necessary for your request ̶ Review software with vendor(s) ̶ Vendor’s completion of Information Security Questionnaire ̶ Information Security Review ̶ Identify necessary budget 22

Research IS Program requests should be submitted via ServiceNow Login to ServiceNow Click Service Catalog Find Research section and click Research Request Complete form Click Submit Form is routed directly to the Research IS group for prioritization 23

Providing information in the submission will help the Research IS Program better assist the researcher in engaging with the technology Provided by the researcher Allows the Research IS Program to Overview of research study Properly represent the request to research and IT offices; provide recommendations on software End-to-end workflow Ensure vendor accountability to provide the support needed by the researcher Clear list of IT requirements Identify all tasks and approach Funding Identify appropriate contractor and IS support. Research IS Program is dependent on external funding, particularly when a consultant is necessary to complete the work (most Epic enhancements will require a consultant). Milestones/deadlines Prioritize projects based on grant submission or implementation date Maintenance plan Understand plan for systems after grant runs out (e.g., sunset IS system, maintain with internal support, maintain through ongoing grant support) Early IT engagement Provide appropriate IT budget and resources for research study 24

Questions 25

Clinical Trial Office FY20 Achievements and FY21 Strategic Plan

Clinical Trials Office FY20 Achievements 27

FY20 Achievements COVID-19 Summary and Update CTO Metrics ̶ COVID contracts were setup in record times, sometimes under two weeks (Add. 1) ̶ Decreased average CDA execution from 2 months to 10 days (Add. 1) ̶ Roughly double the amount of contracts were executed in FY20 than in FY19 (Add. 1) ̶ Total project dollars have increased about 10% every year over the past 4 years (Add. 2) ̶ Usage of Velos has increased 11% with 815 new participants entered this year (Add. 3) Epic Research Billing Enhancement Project ̶ Completed re-design of Epic research billing logic and work queue holds (Add. 4) ̶ Due to increasing research and several other factors, charges being reviewed in Epic have increased by 100% (Add. 5) Updated Research Operations scope (Add. 6) 28

BMC/BU COVID research opportunity timeline March 13th: Leadership halted most in-person research activity March 25th: Leadership dedicated COVID research resources, at this point BMC was not selected as a site for any COVID research, and combined forces with physician led group identifying research opportunities April 27th: Unprecedented 10-day turnaround 3 trials: signed CDA to Active & Enrolling COVID research infrastructure was built from scratch Centralized review of ALL COVID research opportunities to 1 person, team developed tracking mechanism In parallel, assembled grassroots physician group to source research opportunities Developed 17 person Scientific Review Committee to discuss protocol scientific validity of performing human subjects research at BMC/BU, created review scoring and tracking mechanism Gathered variety of stakeholders (e.g. IT, nursing, phlebotomy) and drafted SOPs Created inpatient support team for centralized oversight of trials in the hospital Developing other research review committees: Biospecimens, Ambulatory and Data Implemented Active Research Flag and remote monitoring ChartLink access in Epic March 13th, we had no COVID clinical research opportunities, as of May 11 th, BMC/BU had 53 Active or in the pipeline 29

Since the beginning of the COVID surge in Boston, our academic teams have been involved in 19 studies to help us better understand this disease Selinexor (Sanchorawala) Biorepository (Bhadelia) April Ruxolitinib (Sarosiek) May Prone positioning (Bosch) Rapid diagnostic evaluation (Belok) Direct antigen rapid test (Kataria) RNA Vaccine* (Barnett) Etoposide (Sloan) Tocilizumab (Lin) Canakinuma b (Neogi) MAS825 (Siddiq) STOP (Jacobson) N 394 SIG-COVID (Kataria) N 1426 June Favipiravir (Marathe) Hydroxychloroquine (2) – Out Pt TX and Prophylaxis (Paasche-Orlow) Ravulizumab (Ieong) Eculizumab – EAP (Ieong) Tocilizumab & Remdesivir (Lin) To date, these studies have enrolled 271 patients (excluding specific BMC employee studies) * Indicates executed study pending recruitment. All others are studies completed or actively recruiting. 30

BMC collaborated with BU’s GCRU to successfully develop and run a COVID research program 10 COVID interventional trials completed enrollment Apr-Dec 265 PARTICIPANTS ENROLLED IN VACCINE TRIAL Actively recruiting COVID Studies 16 Source: internal BMC data updated as of 12/31/20 Participants Enrolled in Interventional Trials 300 Participants enrolled in COVID ambulatory research 1980 PARTICIPANTS ENROLLED IN SAMPLE COLLECTION PROTOCOLS 300 COVID-RELATED PUBLICATIONS 1844 CREATED Biorepository & Discarded tissue COLLECTION TO ADVANCE COVID RESEARCH COVID RESEARCH TRIALS IN PREAWARD PIPELINE 31 31

Research During COVID and Beyond General COVID-19 Research Information: https://www.bmc.org/covid-19/covid-19-research-related-information Remote Study Design Guidance Document: https:// www.bmc.org/sites/default/files/Research/Remote Study Design Optimizing Feasibility During C OVID-19.pdf VNA: see page 2 and contact CTO if: 1. PI initiated submission could incorporate VNA visits to reduce hospital volume or 2. if study sponsor requests VNA to execute some, or all, of the schedule of events Remote Study Monitoring: see pages 3&4 Contact CTO for SOP and sponsor agreements, takes about 4-weeks to set-up Research Compliance is developing auditing program Research Restart (evaluate all clinical research to determine feasibility during pandemic) https://www.bmc.org/sites/default/files/Research/documents/High Level Research Restart.pdf 32

Clinical Trials Office FY21 Strategic Plan 33

Lo ng -te rm vis io n FY21 Strategic Vision co lla bo r rs hi p Le ad e CT O pr oc es s im pr ov em en t research engageme nt 5. Continue to support COVID clinical research program 6. Identify methods for remote research at io n 1. Collaborat e with Departme nt Administra tors 2. Imbed clinical research in clinical model 3. Think differently about clinical trial D&I enrollment 4. Work with CTSI: GCRU and CRRO on clinical 34

FY21 Goals Health Equity and Clinical Research ̶ Study material central translation support Trigger discussion with sponsor upfront: central IRB translation and what languages or budget for translation to occur Top 4 languages spoken by BMC patients: English, Spanish, Haitian Creole, and Vietnamese Since April translated on behalf of 15 studies, that did not have central IRB, with 26 forms translated Will continue to trigger pre-award discussions and provide central support ̶ BMC Patient eEngagement- A Phase Approach (Add. 15) ̶ Incorporate Clinical Research into Clinical Framework E.g. engage Hospitalists, advertise research, improve website, report research updates to leadership Clinical Research Network collaboration with Department of Medicine ̶ Provide regulatory guidance for under supported PI’s and new medicine i.e. COVID ̶ Engage the community to increase D&I around research (Add. 14) ̶ Partner with CTSI: GCRU and Community Engagement Core 35

COVID Clinical Research Demographics March-Dec 2020 36

FY21 Goals, continued CTO Proposal Support and Hospital feasibility discussions ̶ Psychiatry case study example ̶ CTO Brochure for departments and PI’s (Add. 9) Expense/Effort Tracking discussions at monthly meetings (Add. 7 & Add. 8) TriNetX & Boston Medical Center (Add. 10) Velos outreach and education ̶ FAQ (Add. 11 & Add. 13) ̶ Awareness and ongoing education (Add. 12) 37

CTO Proposal Support Case Study Psychiatry’s Director of Research connected Principal Investigator with Research Operations to evaluate clinical needs of the protocol 1.5 months in advance of an R01 deadline Initial meeting with Research Operations and PI prompted: 1. language translation quote to be included in grant submission for: Consent and psychiatry evaluations 2. leadership meeting scheduled to confirm availability of Psychiatry clinic staff and OBGYN clinic space for research 3. budget projection discussions on how to reimburse clinic staff and space for the course of the study We have several experiences where CTO has not been included in submission feasibility, and if award is granted, may end up in significant lack of funds to cover costs or inability to perform research For more information please refer to Add. 6 for Research Operations Roles and Responsibilities and Add. 9 for Department one-pager on CTO Submission Support 38

Clinical Trials Office Addendums 39

(Add. 1) Clinical Trial Office roles and responsibilities 1. Clinical cost for budget projections 2. Research pricing management 3. Manage Medicare Coverage Analysis process and interpretation 4. Research billing compliance 5. Velos management and Epic interface 6. Epic report for clinical charges routed to research fund 7. ClinCard management 40

(Add. 2) Post-Award Total Project ’s Completed clean-up of aging protocols from previous FYs COVID interrupted regular workflow for new projects, but added some COVID protocols 41

(Add. 3) Post-Award: Participant Tracking in Velos Even though COVID slowed down enrolled for most Active protocols and prevented execution during March-July, BMC still saw a higher use of Velos than FY19 We expect to see a continued rise in the use of Velos because: Improved educational material and outreach GCRU will enter all studies in Velos as of Jan ‘21 New “Research Active” flag in Epic is set by Velos enrollment Increased focus on recruitment methods and outcomes 42

(Add. 4) Epic Research Billing Enhancement Project: October 2019- May 2020 Project goal: to improve the research billing workflow to reduce denials and ensure proper flagging of patients as research participants Collaborated with ITS, RIS, Revenue Cycle, Finance, and Accounting Tested Velos/Epic interface with: RIS, ITS, and Velos/Epic team to remap patient statuses, send additional fields (funding source & CMS QCT status), study/patient data transfer after upgrades to the interface Tested improvements to the billing workflow logic in Epic--automating addition or removal of modifiers and codes based on Fernanda/Bryant's research billing review and new workqueues for PB and HB charges Cleaned up existing data in Velos and Epic--adding missing information such as NCT#, funding source, CMS QCT status, etc. Confirmed cash processing with accounting from study account to HB and PB 43

(Add. 5) Post-Award: Epic Charges and Research Billing Review (RBR) Completed re-design of Epic research billing logic and work queue holds COVID inpatient studies may have increased the volume of RBR PB and HB charge review Increased Velos education and overall CTO outreach, may have increased participant enrollments and HB/PB charge routing 44

(Add. 6) Research Operations Scope/Intake Research Operations Scope/Intake Grant and Contracts Scope Clinical Trials Office Scope 1. Government agency, foundation funded, or PI 1. Industry AND IRB: Expedited, full-board review, or initiated exempt 2. Industry AND basic science/non human research 2. All non-disclosure agreements (NDAs) 3. All material transfer agreements (MTAs) 3. All confidential disclosure agreements (CDAs) 4. All data transfer/use agreements (DTAs, DUAs) 5. All sub awards Crossover Scope All research protocols with participant service/item/intervention/space - CTO Consultation for all protocols with human subject research send to [email protected] for high level review. If further CTO review is needed, CTFA will be included. - If further CTO review is needed CTFA will be assigned and supply budget consultation Research Ops lead Agreement type Department action Research Ops lead Protocol funding source and type of research Department action Research Operations agreement intake process Grants & Contracts Clinical Trials Office MTAs, DTAs, DUAs, sub awards CDAs and NDAs Online webform Online webform Research Operations software system data entry flow Grants & Contracts Clinical Trials Office 1. Government agency, foundation, PI initiated w/ external 1. industry or internally AND; funding 2. IRB: expedited, full- board review, or exempt 2. All basic science Create lnfoEd record Create Velos record 45

(Add. 7) Post-Award: Expenses on Studies Expenses may not be accurately allocated onto CTO accountsarea of focus for FY21 46

(Add. 8) Grant Expense Cube Project: Develop an automatic cube to provide organized grant expense data based on Infor and estimate personnel expense in the future. Impact: Allow study team to check grants financial data in a centralized tool. Outcome: ̶ Study team can access to different levels’ financial data: Section Summary, Project Detail, Personnel Cost Summary; ̶ Study team can check projected personnel cost burn rates and project balance; ̶ Cube is connected to Infor, which can refresh automatically. 47

(Add. 9) CTO Proposal Support 48

(Add. 10) TriNetX Research at BMC TriNetX & Boston Medical Center Apply a Data-Driven Approach to Clinical Research TriNetX is the global health research network that optimizes clinical research and enables discoveries through real-world evidence. Use TriNetX to identify patient cohorts, participate in sponsored trials, and analyze real patient data. Explore data and Discover Cohorts Find groups of eligible patients using “TriNetX Live” by adding terms for your inclusion and exclusion criteria using a simple easy to use interface. Pursue a grant or identify the patients for recruitment. Participate in Sponsored Trial Receive trial requests through from industry partners or new sponsors via “Trial Connect”. Get early insight into the study population of interest and explore your patient population to determine feasibility and interest. Analytics: Replicate Trials and Develop Protocols Using “TriNetX Research”, perform advanced analyses including analysis of risk factors and comparison of treatments. Explore current therapy landscapes for diseases of interest. Obtain a risk ratio and Kaplan-Meier analysis in minutes – without statistical software. Who is eligible to use BMC TriNetX? Currently, BMC and BUMC researchers who have human subjects research training and a BMC active directory account. How do I get access? To request access to the TriNetX platform please email Nicholas Trombley ([email protected]). . How do I learn how to use the system? Upon receiving access to the platform, you will receive a quick start guide that will help you login and navigate to the training center within TriNetX. Additional information is also available at: https://trinetx.com/ Who can I contact with additional questions? If you have any questions please contact Nicholas Trombley ([email protected]). What data are available in the system? BMC is a member of the TriNetX Research Network. BMC data can be evaluated alone or in combination with over 45 other institutions. For BMC, a subset of data from the BMC Clinical Data Warehouse are transformed into a de-identified limited dataset and uploaded to TriNetX every 1-2 months. For added privacy protection all dates for an individual are adjusted by - 30 days. Data uploaded dates back to 2000 and include: diagnoses, medications, laboratory results, encounters, vital signs, and demographic features. Narrative notes and results are not shared. 49

(Add. 11) What is VelosCT? VelosCT is a Clinical Trial Management System (CTMS) VelosCT connects financial, administrative and clinical research activities to help manage studies Links study status, participant enrollment, calendars, budgets, and participant status to ensure compliant billing to Medicare/third party payers Other capabilities include budgeting, milestones, billing, protocol management, participant recruitment & management, query management, adverse event reporting, etc. 5 0 50

(Add. 12) How does Velos impact my clinical research work? VelosCT will allow you to enter data and upload documents that the Clinical Trial Office (CTO) needs to initiate your studies internally You can now initiate your IRB application in VelosCT (See VelosCT IRB Interface document) CTO will build study calendars with visits/events, coverage analysis, budget, and milestones for your study Once your study is active, you will be able to manage participants throughout the research process including, recruitment, enrollment, scheduling, visit/event tracking, data entry, notifications and monitoring All participants must be enrolled within 24 hours of the research visit, and associated to calendars with visits updated within 24-48 hours of when they occur. 51

(Add. 13) What studies will I have to enter? All New studies must include the submission of the MCA/VelosCT Determination Checklist All studies managed by CTO will be entered in VelosCT. All studies that have hospital services will also be entered in VelosCT. This applies whether the study is managed by BMC or BU. If BMC infrastructure and/or clinical services are utilized, the study will need to be in VelosCT. In addition to studies, VelosCT will also be used to track legal documents (work with your assigned CTFA to enter these): Confidential Disclosure agreements (CDAs) Non-disclosure agreements (NDAs) 5 2 52

(Add.14) To ensure our work effects systemic change, we are taking the groundwater approach We have a vision to establish an action-oriented approach to clinical research that acknowledges systemic inequities, learns from past mistakes, empowers historically disenfranchised individuals, invests in community engagement, and builds an environment of trust and inclusion Stop expecting individual study teams to tackle deeply-rooted issues on their own Build-off of successful COVID centralized administration to co-design with the community and lead technology solution Increase research participation and career opportunity locally and around the world Embed research into the Boston HealthNet clinical model 53

(Add. 15) BMC Patient Engagement Phase I Developed Research Facilitator role to centralize inpatient and outpatient COVID approach, consent, enrollment, and participation declines Began April 2020 and formalized in Dec 2020 Phase II COVID Inpatient Research Liaison daily Rounds with Hospitalist teams (began Jan 2021) COVID-19 Research Flyers in patient rooms & ILI clinic (English, Spanish, and Haitian Creole) Movement away from siloed research protocol recruitment method and into a culture shift of including research as a part of clinical model Phase III New Clinical Research Network to have Recruitment Specialist lead (starts 3/1) community discussions around research Develop ½ day retreat on Clinical Research, Health Equity, and Community Engagement Work with Communications, IRB, and others to think differently about community engagement Develop Research Registry for BMC patient to express interest in research Collaborate with Cancer Clinical Trial Office on their enrollment initiatives and outreach Report annual demographic data, and evaluate methods 54