Seminars & Workshops

Seminar Materials

Seminar video (mp4)

Seminar slides (PowerPoint)

NIH Clinical Trial Requirements

Annotated Form E (PDF)

Seminar Info

Are you an NIH grant applicant, awardee, researcher or research administrator?
Feeling unprepared to grasp all regulatory changes scheduled to take effect in 2018?

Join us on December 5 at a seminar entitled Expert Feedback on Changing Policies for NIH-funded Studies. You will gain in-depth insights into recently announced requirements for NIH clinical trials grants and how the changes will affect you. Anyone planning to apply for an NIH grant early next year is strongly encouraged to attend.

This two-hour interactive seminar will feature joint presentations from regulatory experts representing the Tufts Health Sciences Institutional Review Board (IRB) and the Tufts University and Tufts Medical Center research administration offices. The expert panel will highlight the following topics, and current Tufts IRB-specific responses to the changes and recommendations for addressing potential roadblocks. Each topic will include a short presentation, followed by panel responses and audience Q&A.

Have questions? Please submit your inquiries when you register or email us at training@tuftsctsi.org. We will try to address all questions during the session!

Seminar Topics

• Introduction & Review of New Requirements
• NIH Policy Definition of Clinical Trials
• Good Clinical Practice (GCP) Training
• Single IRB: What Investigators Need to Know
• ClinicalTrials.Gov
• Other Changes to Note, Discussion, and Closing Remarks

Speaker Panel

• Andreas Klein, MD, Director, Regulatory Affairs, Tufts CTSI; Tufts Medical Center; Chair, Tufts Health Sciences Institutional Review Board
• Kathleen Benoit, Senior Research Administrator, Tufts University, Office of the Vice Provost for Research (OVPR)
• Frederick M. Frankhauser, JD, MBA, RPh, Director, Grants & Contracts, Tufts Medical Center
• Marcia Izzi, MPH, Business Finance Manager, Tufts CTSI
• Meghan Coughlin, MS, Research Administrator, Office of Research Administration, Tufts Medical Center

After attending this session, you should be able to:

• Identify tools and resources for determining if your study is a clinical trial and what actions are required for an NIH grant proposal, IRB applications, and study reporting
• Outline financial and administrative prerequisites needed to collaborate with other institutions under the single IRB requirement
• Describe the importance of engaging Tufts IRB in the early stage of proposal development

Details

Tuesday, December 5, 2017, 1:00-3:00PM
Jaharis Family Center for Biomedical Education and Nutrition Sciences, Behrakis Auditorium
150 Harrison Avenue, Boston MA 02111
Or via live, interactive webcast (a link will be provided to those who register).

Registration

Please click here to register to attend.

This seminar is sponsored by Tufts CTSI.

Seminar Materials

• Seminar video (mp4 Video)
• Seminar slides (PDF)
• Reviewer info (PowerPoint)
• Reviewer templates
• NIH Guidelines (PDF)
• NIH Regional Seminar slides (PowerPoint)
• NIH Training Module (HTML5 Video)

Seminar Description

Do you have questions about recent changes to National Institutes of Health (NIH) and Agency for Healthcare Research and Quality (AHRQ) grant applications regarding scientific rigor and transparency? Get the latest information at Expert Feedback on NIH Rigor and Transparency Guidelines, led by John Castellot, PhD, Tufts CTSI Navigator and NIH Study Section Chair, and Amy Gantt, MA, Tufts University Director of Research Development.

Faculty members who participated in recent NIH study sections will provide valuable feedback and advice on how to include scientific rigor and transparency in your next grant.

Susan Blanchard, Vice President, Research Administration, Tufts Medical Center, will also update participants on the new Department of Labor (DoL) overtime pay protections under the Fair Labor Standards Act (FLSA).

By the end of this seminar, participants will be able to:

• Describe specific feedback from faculty who served on NIH study sections
• State how to apply the new guidelines to their grant proposals
• Discuss how to include scientific rigor and transparency in their grant
• Explain the implications of the Department of Labor overtime pay protections under the Fair Labor Standards Act (FLSA).

This event is hosted by Tufts University and Tufts Medical Center. Faculty members from both institutions will participate in the discussion.

Details

Thursday, June 23, noon – 1:30PM
Jaharis Family Center for Biomedical Education and Nutrition Sciences, Behrakis Auditorium, 150 Harrison Avenue, Boston MA 02111
Or via live, interactive webcast (a link will be provided to those who register).

Registration

All are welcome to attend. Please register online.

Seminar slides

Seminar handout

Do you know about the planned changes to policies, forms and instructions for National Institutes of Health (NIH) and Agency for Healthcare Research and Quality (AHRQ) grant applications submitted in 2016? Beginning in January, these changes will impact how you develop and write your research strategy section. In addition, there are form and format changes to the SF424 application package.

Find out more information and specific details at Planning for NIH/AHRQ Grant Application Changes, led by Tufts University’s Zoya Davis-Hamilton, EdD, CRA, Senior Associate Director of Research Administration and Amy Gantt, MA, the Director of Research Development.

This seminar reviews upcoming changes to rigor and transparency in research, inclusion reporting, data safety monitoring, vertebrate animals, definition of child, research training, appendices, biosketch clarifications, font requirements and post-award changes.

The seminar is split into two sections, the first half will focus on the changes to the research strategy section of the application and the second half will focus on the administrative changes.

By the end of this seminar, participants will be able to:

• Identify the changes to the NIH/AHRQ policies, instructions and forms
• Explain which changes are required in January 2016 and which changes will be required in May 2016
• State details on each area of change
• Describe how to apply the new guidelines
• Discuss how to include robust and unbiased results factoring.

This event was hosted by Tufts University and Tufts Medical Center.