Office of Regulatory Affairs & Research Compliance
5th Annual QA/QI Boot Camp
Agenda
Day 1: Foundations of QA/QI
8:00-8:30 AM Registration (coffee/tea service)
8:30-8:45 AM Welcome
8:45-9:30 AM Keynote
Faculty: Delia Wolf, MD, JD, MSCI
Associate Dean, Regulatory Affairs & Research Compliance,
Harvard T.H. Chan School of Public Health
9:30-10:45 AM Panel: Developing a Sustainable QA/QI Program
Moderator: Delia Wolf, MD, JD, MSCI
Panelists: Emilie Jade Misajon, BSN, RN, CCRP
Research Quality Improvement Program (QIP) & Education, Atlantic Center for Research, Atlantic Health System
Jennifer A. Graf
Manager, Human Research Protection Program and Research Integrity, Cambridge Health Alliance
Andrea Saltzman
Associate Director, Office of Research Subject Protection, Broad Institution
This session will examine some approaches in developing a thriving QA/QI program. Panelists with each have 15 minutes to introduce their QA/QI Program, including its structure; how they defined its scope and goals, and/or how each program effectively engages their respective research communities. The moderator will facilitate an open question and answer period.
10:45-11:00 AM Break
11:00 AM-12:15 PM Didactic: Proactively Ensuring Compliance through QA/QI Services and
Tools
Faculty: Eunice Yim Newbert, MPH
Manager, Clinical Research Compliance, Education and Quality Improvement Program, Boston Children’s Hospital
Attendees will hear some of the common and not so common QA/QI services designed to support the research community and share corresponding study management tools that QA/QI Programs may adapt and offer. Attendees will be encouraged to share their own offerings, including those that have been successful and those that have not.
12:15-1:15 PM Lunch
1:15-2:30 PM Didactic: Unique Auditing Challenges
Faculty: Sarah White, MPH, CIP
Director, QI Program, Partners HealthCare
Each research portfolio is unique and presents its own auditing challenge, e.g., multi-site or international research; ceded research. In this session panelists will illuminate how they have overcome auditing obstacles effectively.
2:30-2:45 PM Break
2:45-4:00 PM Workshop: Correcting and Avoiding Non-compliance: Examining Some
Real-life cases
Faculty: Leslie Howes, MPH, CIP
Managing Director, Office of Human Research Administration
Harvard T.H. Chan School of Public Health & Harvard University Faculty of Medicine
After a brief introduction, attendees will be presented with a number of fact scenarios to discuss and determine how best to resolve. Resolutions are intended to include a variety of components designed to both correct and avoid future instances of non-compliance. Scenarios will include both the routine and the unique. Attendees are encouraged to share their own “cases” for group discussion.
Day 2: Applications of QA/QI
8:00-8:30 AM Registration (coffee/tea service)
9:00-10:15 AM Panel: Innovations in QA/QI
Moderator: TBD
Panelists: TBD
This panel will showcase 3-4 different innovations in QA/QI, e.g., development of an eRegulatory Binder.
10:15-10:30 AM Break
10:30-12:30 AM Workshop: Investigator Mock Audit
IRB Mock Audit
Faculty: Lisa Gabel, CIP
Leslie Howes, MPH, CIP
Alyssa Speier, MS, CIP
As a hallmark of the Harvard T.H. Chan School of Public Health QA/QI Boot Camps, this workshop with provide attendees a chance to participate in a simulated audit of an IRB or investigator’s files. Attendees will breakout into either the IRB or Investigator audit group and receive/review study files. Working in small teams, they will be asked to identify deficiencies in the record keeping practices. Mock audit groups will come together to discuss findings and possible corrective action/best practice recommendations.
Note for Returning Attendees: The same materials used for the Mock Audit have been reviewed by Boot Camp attendees in past years. If you are a returning attendee, you may be able to spot new findings. Additionally, our session this year will go a step further and corrective actions/best practice recommendations will be discussed to address the findings that the participants make during the mock session.
12:30-1:30 PM Lunch
1:30-2:45 PM Workshop: Communicating for Compliance: How to Effectively Share
Findings
Faculty: Alyssa Speier, MS, CIP
Assistant Director, Office of Regulatory Affairs & Research Compliance, Harvard T.H. Harvard School Public Health
QA/QI teams need to communicate their findings across a wide range of audiences including investigators, IRB staff/members, and senior leadership at an organization. This session will provide strategies for presenting findings/data, being mindful of the target audience(s) and their specific needs. Attendees will breakout into small groups to role-play ways to provide constructive, supportive, and effective feedback to IRB staff/members/senior leadership as well as PI and study team. The large group will wrap up by reviewing and commenting on their experience .
2:45-3:00 PM Break
3:00-4:15 Didactic: Expanding your QA/QI Program to Successfully Evaluate
the IRB
Faculty: Jessica Randall, MA, CIP
Compliance Manager, Research Quality Assurance & Compliance, Human Research Protection Program (HRPP)
Yale University
Attendees will learn some ways in which IRB/Institutional compliance can be evaluated and improved. This session will discuss strategies and tools for conducting audits of the IRB files, meeting minutes, and membership composition.
4:15 Adjournment
Agenda subject to change
Version date: August 3, 2016 Page
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