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From the Project Manager’s Desk: Insider Views on Preempting Study Issues and Optimizing Study Procedures

Course
Virtual
2.5 CE Hours
General
Free

Presented By

  • -
    Live Webinar
  • -
    Live Webinar

Location

  • Live Webinar
    Access virtually on TPN.health
Description

Managing a study is not just about following your IRB protocol. This highly pragmatic webinar series is designed to help project leaders and managers strengthen and energize your study operating procedures for behavioral and health services research in the cancer context. The series is a special joint initiative by the Society of Behavioral Medicine’s Cancer Special Interest Group and the American Psychosocial Oncology Society. We will focus on strategies to enhance procedural rigor while facilitating vibrant, inclusive, and supportive environments for your single- or multi-site research teams. Seasoned project managers will provide an insider’s view into real situations and solutions for setting up your project for success, integrating procedures into busy clinics and community settings, and bringing out the best in your research teams. We will discuss common study issues (e.g., staff turnover, study delays, data inconsistencies, low enrollment) and how to preempt or problem-solve them. This information will be relevant to project managers as well as principal investigators across the career spectrum. While our focus will be on single- and multi-site trials, the takeaways will be relevant to a broad range of behavioral and health services research. Questions and examples will be solicited from attendees, with the opportunity to discuss key issues related to project execution.

Target Audience
  • Counselors
  • Substance Use Disorder Professionals
  • Psychologists
  • Social Workers
  • Licensed Marriage and Family Therapists
  • Physicians
  • Nurses
  • Research Project Managers
  • Research Coordinators
References
  • Cobb N, Witte E, Cervone M, Kirby A, MacFadden D, Nadler L, Bierer BE. (2019). The SMART IRB platform: A national resource for IRB review for multisite studies. J Clin Transl Sci, 3(4):129–139.

  • Deary EC, Daskalakis E, Abrahm JL, Morris SE, Amonoo HL. (2023) At a loss: patient deaths and clinical research coordinators. J Clin Oncol, 41(16):3072-3073.

  • Fiss AL, McCoy SW, Bartlett D, Chiarello LA, Palisano RJ, Stoskopf B, Jeffries L, Yocum A, Wood A. (2010). Sharing of lessons learned from multisite research. Pediatr Phys Ther, 22(4):408-416.

  • Goodlett D, Hung A, Feriozzi A, Lu H, Bekelman JE, Mullins CD. (2020). Site engagement for multi-site clinical trials. Contemp Clin Trials Commun,19:100608.

  • Gordon VM, Culp MA, Wolinetz CD. (2017). Final NIH Policy on the use of a single institutional review board for multisite research. Clin Transl Sci, 10(3):130–132.

  • Gwede CK, Johnsson DJ, Roberts C, Cantor AB. (2005). Burnout in clinical research coordinators in the United States. Oncol Nurs Forum, 32(6):1123-30.

  • Mascaro JS, Palmer PK, Ash MJ, Peacock C, Escoffery C, Grant G, Raison CL. (2021). Incivility Is associated with burnout and reduced compassion satisfaction: a mixed-method study to identify causes of burnout among oncology clinical research coordinators. Int J Environ Res Public Health, 18(22):11855.

  • McDonald E, Zytaruk N, Heels-Ansdell D, Smith O, Borges D, Hand L, Clarke F, Nassar A, Bennardo M, Cook D, Canadian Critical Care Research Coordinators Group. (2020). Motivators and stressors for Canadian research coordinators in critical care: The MOTIVATE survey. Am J Crit Care, 29(1):41-48.

  • Musshafen LA, Poger JM, Simmons WR, Hoke AM, Hanson LN, Bondurant WW, McCullough JR, Kraschnewski JL. (2021). Strengthening the clinical research workforce through a competency-based orientation program: Process outcomes and lessons learned across three academic health institutions. J Clin Transl Sci, 5(1):e178.

  • Smith L, Tan A, Stephens JD, Hibler D, Duffy SA. (2019). Overcoming challenges in multisite trials. Nurs Res, 68(3):227-236.

  • Steinhilber KM, Chabria RS, Clara A, Temel JS, Greer JA, Traeger L, Jacobs JM. (2023). Shifting behavioral intervention research to virtual methods: Challenges and solutions in practice, during and after the COVID-19 pandemic. J Telemed Telecare, epub. PMID: 37125429. PMCID PMC10130932

  • Suver CM, Hamann JK, Chin EM, Goldstein FC, Blazel HM, Manzanares CM, Doerr MJ, Asthana SJ, Mangravite LM, Levey AI, Lah JJ, Edwards DF. (2020). Informed consent in two Alzheimer's Disease Research Centers: Insights from research coordinators. AJOB Empir Bioeth, 11(2):114-124.

Intermediate
General
Counselors

TPN.health has been approved by NBCC as an Approved Continuing Education Provider, ACEP No. 7267. Programs that do not qualify for NBCC credit are clearly identified. TPN.health is solely responsible for all aspects of the programs.

 

Course meets the qualifications for hours of continuing education credit for LPCCs as required by the California Board of Behavioral Sciences. TPN.health is approved by the California Association of Marriage and Family Therapists to sponsor continuing education for LPCCs. TPN.health maintains responsibility for this program/course and its content.

 

Trusted Provider Network, LLC is recognized by the New York State Education Department’s State Board for Mental Health Practitioners as an approved provider of continuing education for licensed mental health counselors. #MHC-0220.

Substance Use Disorder Professionals

This course has been approved by TPN.health, as a NAADAC Approved Education Provider, for educational credits. NAADAC Provider #198061, TPN.health is responsible for all aspects of the programming. Counselor Skill Group: Legal, Ethical and Professional Development.

Psychologists

Trusted Provider Network is approved by the American Psychological Association to sponsor continuing education for psychologists. Trusted Provider Network maintains responsibility for this program and its content.

 

Trusted Provider Network, LLC is recognized by the New York State Education Department’s State Board for Psychology as an approved provider of continuing education for licensed psychologists #PSY-0125.

Social Workers

TPN.health, #1766, is approved to offer social work continuing education by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program. Organizations, not individual courses, are approved as ACE providers. State and provincial regulatory boards have the final authority to determine whether an individual course may be accepted for continuing education credit. TPN.health maintains responsibility for this course. ACE provider approval period: 03/31/2022 – 03/31/2025. Social workers completing this course receive 2.5 continuing education credits.

 

Course meets the qualifications for hours of continuing education credit for LCSWs as required by the California Board of Behavioral Sciences. TPN.health is approved by the California Association of Marriage and Family Therapists to sponsor continuing education for LCSWs. TPN.health maintains responsibility for this program/course and its content.

 

Trusted Provider Network, LLC is recognized by the New York State Education Department’s State Board for Social Work as an approved provider of continuing education for licensed social workers #SW-0654.

Licensed Marriage and Family Therapists

Trusted Provider Network, LLC is recognized by the New York State Education Department’s State Board for Mental Health Practitioners as an approved provider of continuing education for licensed marriage and family therapists #MFT-0097.

 

TPN.health is a CAMFT-approved continuing education provider, provider # 1000101.

Physicians

In support of improving patient care, this activity has been planned and implemented by AXIS Medical Education and Trusted Provider Network/TPN.health. AXIS Medical Education is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive a maximum of 3.0 Interprofessional Continuing Education (IPCE) credit for learning and change.

 

Credit Designation for Physicians

AXIS Medical Education designates this live activity for a maximum of 3.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

 

Learners are advised that accredited status does not imply endorsement by the provider or ANCC of any commercial products displayed in conjunction with an activity.

Nurses

In support of improving patient care, this activity has been planned and implemented by AXIS Medical Education and Trusted Provider Network/TPN.health. AXIS Medical Education is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive a maximum of 3.0 Interprofessional Continuing Education (IPCE) credit for learning and change.

 

Credit Designation for Nursing

AXIS Medical Education designates this continuing nursing education activity for a maximum of 3.0 contact hours.

 

Learners are advised that accredited status does not imply endorsement by the provider or ANCC of any commercial products displayed in conjunction with an activity.

CE Policy
This course is fiscally sponsored by American Psychosocial Oncology Society (APOS) . There may be potential biases or conflicts of interest inherent to this relationship, and it must be disclosed to participants. These conflicts of interest have no bearing on the course content and have been resolved. Disclosure of Relevant Financial Relationships AXIS Medical Education requires faculty, instructors, authors, planners, directors, managers, peer reviewers, and other individuals who are in a position to control the content of this activity to disclose all personal financial relationships they may have in the past 24 months with ineligible companies. An ineligible entity is any organization whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. All relevant financial relationships are identified and mitigated prior to initiation of the planning phase for an activity.  AXIS has mitigated and disclosed to learners all relevant financial relationships disclosed by staff, planners, faculty/authors, peer reviewers, or others in control of content for this activity. Disclosure of a relationship is not intended to suggest or condone bias in any presentation but is made to provide participants with information that might be of potential importance to their evaluation of a presentation or activity. Disclosure information for faculty, authors, course directors, planners, peer reviewers, and/or relevant staff is provided with this activity. The faculty reported the following relevant financial relationships or relationships they have with ineligible companies of any amount during the past 24 months: Name of Faculty or Presenters Reported Financial Relationship Chardria Trotter, MBA, MPH, CPH Nothing to disclose Deanna Witte, MSMS Nothing to disclose Kathryn Post, PhD, CNP Nothing to disclose Lara Traeger, PhD Nothing to disclose Maija Reblin, PhD Nothing to disclose Jamie Jacobs, PhD Consultant: Reunion Neuroscience, Inc The directors, planners, managers, reviewers, and relevant staff reported the following financial relationships they have with any ineligible company of any amount during the past 24 months: Name of Planner/Manager/Reviewer/Staff Reported Financial Relationship Kathleen Stevens Nothing to disclose Ronald Viggiani, MD Nothing to disclose Jan Schultz, MSN, RN, FACEHP, CHCP Nothing to disclose Dee Morgillo, Med, MT(ASCP), CHCP Nothing to disclose Disclaimer   Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
Note: Time designated for waiting room, breaks cannot be counted toward CE credit.
Chardria Trotter, MBA, MPH, CPH

Chardria Trotter is a Project Director with the Cancer Outcomes Research and Education (CORE) Program at the Massachusetts General Hospital. She holds a Bachelor of Arts in biology and gerontology from the University of Southern California, a Master of Business Administration from Texas Woman’s University, and a Master of Public Health with an emphasis on health management and policy from the University of North Texas Health Science Center. Ms. Trotter’s research experience encompasses health disparity, rare diseases, quality of life, and patient-reported outcome studies. She has nearly 15 years of oncology experience in project management, partnership cultivation, regulatory compliance, quality assurance, and data integrity — including two large national multi-site trials of palliative care integrated into oncology care.

Deanna Witte, MSMS

Deanna Witte is a Team Lead Research Coordinator in the neuro-oncology clinic at the Moffitt Cancer Center. For the past two years, she has supported the Caregiver Assistance through Resources, Information, and Navigation Guide in Neuro-Oncology (CARING) study and the Total Cancer Care (TCC) study, following an extensive career in clinical medicine. She earned her Bachelor of Music in 2016 at Wheaton College and her Master of Science in Medical Sciences at the University of South Florida. Moffitt has nurtured wonderful growth in her professional development. For the CARING and neuro TCC studies, she aids in study management, organization and coordination of protocol activities, and team member mentorship.

Kathryn Post, PhD, CNP

Dr. Kathryn Post is a nurse scientist in the Massachusetts General Hospital’s (MGH) Cancer Outcomes Research & Education (CORE) Program and the MGH Reich Oncology Nurse Fellowship, and an Instructor at Harvard Medical School.  Dr. Post’s research has been funded by the American Cancer Society and the Sigma Foundation for Nurses. Her interests center on improving the lives and psychosocial outcomes of patients with cancer and cancer survivors through developing tailored, evidence-based interventions. Dr. Post has extensive expertise in managing large research trials. She also has clinical expertise in breast oncology, where she has spent more than 17 years caring for patients with breast cancer as an advanced practice nurse.

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