Wake Forest Clinical and Translational Science Institute (CTSI)

Wake Forest Clinical and Translational Science Institute (CTSI) The Wake Forest CTSI (Donald McClain, M.D., Ph.D., Director) was founded in 2007 and is the hub of the research academic network within the institution. The CTSI’s mission is to provide services and education for the research community to learn about and conduct clinical and translational research. The CTSI seeks to provide an innovative, efficient, and sustainable research infrastructure that speeds the translation of discoveries to improve health, in concert with community and regional academic affiliates. The CTSI is supported in part by a Clinical and Translational Science Award (UL1TR001420; PI: McClain). It includes a Mentored Career Development Program (KL2TR001420; PI: Dr. Stephen Kritchevsky). Main components of the CTSI include: Clinical Research Unit (CRU): This unit helps investigators translate basic scientific knowledge into new or improved methods of patient care by providing clinical investigators with the fundamental resources and controlled environment necessary to conduct research with human subjects. It is the CRU’s policy to prioritize resources for pilot studies and early-career investigators. CRU resources include clinical staff, nursing, and technician support. The CRU provides a team of dietary and laboratory personnel trained in research techniques to support studies with dietary interventions, as well as processing of samples. The main unit of the CRU facility of 6,623 sq. ft. of outpatient research space with nine examining rooms, a metabolic kitchen with the necessary equipment to prepare special meals for studies with feeding components, and a CLIA-certified processing core, with state-of-the-art equipment and freezer capacity for tracking samples through FreezerWorks®. In 2005, the Institution initiated the first Geriatric CRU satellite in the nation. This space, a 2,500 sq. ft. unit, is adjacent to the Geriatric Research Center. This CRU space includes five outpatient exam rooms, a consult room, nurses’ station, waiting area, patient dining room, and access to all main CRU resources.

Office of Clinical Research (OCR): The OCR is a resource for clinical research and study management for Wake Forest Baptist Health (WFBH) and the local community. The OCR's centralized administration focuses on protocol implementation, study coordination, data and regulatory management, clinical research budget development, and clinical trial education. The OCR’s areas of focus are to 1) work with study teams to implement high-quality clinical research that are activated quickly; 2) assist in identification and allocation of resources for conducting clinical trials; 3) assess trial accrual potential and plausible overlap between competing trials; 4) create an infrastructure to support and promote appropriate research billing; 5) maintain an accurate registry of all consented clinical trial participants; and 6) develop tools and training for the clinical research community.

Data Access: Researchers can request data from the TDW and receive identified patient data if they have IRB approval.

Grants Management: The CTSI Grant Management Core provides investigators with reliable, experienced administrative support to assist in all facets of grant management. Grants specialists proactively monitor awards, maintain fiscal compliance, and ensure studies are adhering to all internal and external regulations. Accessing this service can free investigators and study staff of the administrative burden associated with monitoring and managing grant awards. Investigators only pay for the required effort to support the project, rather than hiring a full-time employee. Resources are available in finance, reporting, and facilitation.

I-DSMB: The Institutional Data and Safety Monitoring Board (I-DSMB) is a standing committee available to provide independent oversight for human research studies conducted at WFBMC. Coverage Analysis: Because clinical research often takes place in conjunction with routine clinical care, billing for clinical and research procedures must be distinguished from one another and handled appropriately and in compliance with legal requirements. A Coverage Analysis involves determining a study’s eligibility for Medicare/Medicaid/Private Insurer coverage and reviewing the clinical events specified in the protocol to determine appropriate reimbursement.

REDCap: Research Electronic Data Capture (REDCap) is a free, secure, web-based application for building and managing online surveys and databases. The REDCap system provides secure, web-based applications for a variety of types of research. REDCap provides an intuitive interface for users to enter data and have real- time validation rules (with automated data type and range checks) at the time of entry. Data entry can also take place at a multi-institutional level for a single project. This system offers easy data manipulation with audit trails and reports for reporting, monitoring, and querying patient records; and an automated export mechanism to common statistical packages. The iterative development and testing process results in a well-planned data collection strategy for individual studies. REDCap was implemented at Wake Forest specifically around HIPAA security guidelines. User logins are tied to an individual’s medical center ID and authenticated across platforms. Additionally, REDCap is flexible for external collaborators allowing ease of use for cross-institutional affiliates. Individuals outside of the Wake Forest security system are provided a unique authentication. TSI staff members provide training to guide new users through all features of REDCap, including project start-up, production, reports, and data exports. Trainings are conducted one-on-one or through group consultation.

Research Studios: The TSI Research Studio is a structured format for investigators to receive critical guidance and feedback from experienced faculty representing diverse disciplines. The model provides an integrated group-based approach that assembles research experts to provide support for investigators to develop, design, implement, and analyze various types of translational research projects at a specific stage of development, with the ultimate goal of improving and accelerating their research outcomes. Study Coordinator Pool: This resource provides investigators with reliable, experienced research staff to assist in the start-up, implementation, and closeout of clinical research studies. These services allow investigators to quickly implement and administer research studies and alleviate the administrative burden associated with training and managing research staff. This service also allows investigators to utilize only the amount of effort required for a particular project and is a particular asset for pilot projects or for new investigators. Program in Community Engagement (PCE): The PCE employs a conceptually-based process of community engagement designed to increase the pace of laboratory and clinical science translation to improve population health, health practice, and policy. The PCE has established a collaborative leadership and stakeholder organizations, executed a process of bi-directional communication, and implemented a set of program services. The PCE executive committee, or Core Working Group, develops and implements programs that support community-engaged health programs. Each group member is assigned to a committee or task to aid the group’s work in moving initiatives forward and collaborating with community members. The Core Working Group is also a part of the Stakeholder Advisory Committee. This committee includes community and academic representatives and guides the entire TSI on effective community research collaboration strategies. The group consists of leadership from the academic medical center and community organizations and meets quarterly to review current initiatives and plan for future activities and goals that forward the mission of the TSI and PCE. Educational activities within the CTSI are supported by the KL2 component of the CTSA (KL2TR001420; PI: Kritchevsky). These are focused on KL2-supported Scholars, the Translational Scholar Academy (both for early-stage faculty), a Mentor Academy, and online learning and short courses for the research community and workforce development (through the Study Staff Orientation modules). Content from other sites in the national CTSA network is also available online through the CTSI portal. Translational Research Scholar Academy: The Translational Research Academy is designed to enhance the career development and success of early-career clinical and translational researchers. Faculty who have significant effort devoted to research are eligible to become Academy Scholars. Scholars may continue in the Academy for two years based on progress towards identified goals and active participation in Academy Programs. The Academy provides education and leadership development training, research support services, mentoring, and networking opportunities. The most recent cohort of the Academy includes six cancer-focused translational scientists. Mentor Academy: The CTSI Mentor Academy is a formal, evidence-based, six-month didactic and experiential training program to enhance the mentoring skills of mid-career behavioral, clinical, and translational researchers. Ready-When-You-Are Courses: These brief, online courses (1/4 to 2 hours long) are digital video recordings of faculty/staff presentations along with PowerPoint slides, available at any time and with free access. A simple registration process captures information about users and an evaluation questionnaire determines the value of the course to the learner. Courses are designed to provide faculty, staff, and students an opportunity to learn about the research process with more flexibility than standard courses. Although continuing education credits are not provided, learners can cite them as self-directed learning activities. New courses are added periodically and courses updated as needed. A sampling of these courses is summarized in the table below and is updated regularly on the CTSI Education Program website.

Examples of Courses Available Animal Research Human Research Assistant Laboratory Animal Technician (ALAT) Certification Clinical Trials: Definitions, Types and Regulatory Preparation Course Requirements* Aseptic Technique (Non-Rodents/Rodents) Data Management and FDA Audits: Lessons Learned and Practical Tips* Best Practices for Writing Protocols eIRB User Training: Navigating eIRB Clean Up Your (Lab) Records Getting Started with an Investigator-Initiated Human Research Study* eIACUC Training Sessions HIPAA: What is PHI, What Consent Language is Required, and Other Practical Considerations* Humane Endpoints in Animal Research: What Are They and Why Human Research 101 (Parts 1 and 2)* Do We Need Them?* IACUC Updates IND/DE Holder Responsibilities Laboratory Animal Training: Species-Specific Courses Informed Consent Process: Do’s, Don’ts, and What If’s* Laboratory Animal Technician (LAT) Certification Preparation Multicenter Trials: Coordinating Center and Subsite Course Responsibilities* New Animal Research 101 Paying Subjects: How to Do It Ethically and Stay in Compliance* Non-Rodent Anesthesia Troubleshooting and Ventilation Phlebotomy Skills Development Course Post-Approval Monitoring (PAM) Explained Retention of Research Documents and IRB Oversight After Subject Involvement Ends* Postoperative Monitoring in Non-rodent Mammals Safety Event Submissions: Types, Reporting Requirements, and Timelines* Preparing for IACUC Inspections Specimen Storage; When Can You Do It and What Should Be in the Consent Form?* Recognizing and Alleviating Signs of Pain and Distress Working with the IRB/HRPP: A Practical Introduction to (Rodents/Non-Rodents)* Process and Workflows Reporting Adverse Events Rodent Surgery Using Gas Anesthetics: What You Need to Know Research Support Responsible Conduct of Research ABC’s of CDAs (Confidentiality Agreements) Best Practices for Writing Protocols Anatomy and Physiology of Awards Ethical Considerations of Conflict of Interest: Is Your Science for Sale? Anatomy of a Biosketch Introduction to the Responsible Conduct of Research Budget Basics and Budgeting: Beyond the Basics Sticky Situations in Publishing Contracts; Start to Finish Introduction to Research Administration *Also in Responsible Conduct of Research curriculum Manuscript Writing Material Transfer Agreements (MTAs); Why They Are Important NIH Grants: Start to Finish Preparing and Managing Complex Grants/Contracts Subawards and Subcontracts Training Grants (Institutional or Individual) Transferring Grants and Contracts Writing the Best Introduction for Your Resubmitted Grant Application

TSI Short Courses – In-Person Offerings: Sample courses are summarized in the table below and are updated regularly on the CTSI Education Program website. Introduction to established and state-of-the-art methodology for biomedical studies across the translational spectrum. Topics: introduction to translational science, design of medical research studies, standard statistical tests and data analysis, and publications. Name Audience Overview Clinical Methods Short Course (2 Faculty, graduate Established and state-of-the-art methods for translational sessions) students, TSI scholars, research. Topics: research design, statistical tests and residents, fellows analyses, and best practices in publishing results. Community Research Focus: Academic, non-profit & Use of GIS to study food access issues Geographic Information Systems community organizations, (GIS) and the Commercial Food government agencies Environment Human Genomics Faculty, graduate Principles, methods, and tools of genomics and genetic students, TSI scholars, association in family and population studies. Specific focus on residents, fellows haplotype and linkage analyses, pharmacogenetics, and relevant bioinformatics Introduction to Primate Research Faculty, TSI Scholars, Basic primate behavior, techniques for handling primates medical/graduate students safely, basic research procedures, environmental enrichment strategies, and regulatory issues K-Award Writers Series Faculty aiming to apply for K application process and writing strategies. Participants a K award in the next year develop their proposal during the 9-session course with input from faculty and peers Pilot Skills Development Faculty, TSI Scholars, Pilot study characteristics, writing effective pilot grant medical or graduate proposals, statistics, funding sources, and approaches to peer students, research staff review Research Project Management Faculty, TSI Scholars, Principles, practices, and tools for effective research project medical or graduate management, including planning work schedules, tracking students, senior research progress, managing staff, finances, and time, and achieving staff desired outcomes