Seminars & Workshops
Expert Feedback on Changing Policies for NIH-Funded Studies

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.

 

Drop-In Sessions
Research Help Drop-in Session

Drop-in Sessions, sponsored by the Biostatistics, Epidemiology, and Research Design (BERD) Center, are intended to help Tufts Medical Center/Tufts University researchers resolve questions about study design, statistics, and statistical software including Statistical Analysis System (SAS).

BERD Center Drop-In Sessions are free and staffed by Tufts CTSI epidemiologists and biostatisticians. They can help you tackle clinical research questions, such as:

  • Have I chosen the most efficient and valid study design to investigate this hypothesis?
  • How many people will I need in my study?
  • Which statistical test is appropriate?
  • Could loss of participants be a problem in my study, and how should I handle their missing data?
  • How can I best respond to an IRB stipulation/inquiry?

Research Process Improvement assistance is also available at Drop-in Sessions.

Drop-in Sessions take place every Wednesday from 8:00 – 9:00am at 35 Kneeland Street, 10th Floor Conference Room, Boston.

Drop-In Sessions
Research Help Drop-in Session

Drop-in Sessions, sponsored by the Biostatistics, Epidemiology, and Research Design (BERD) Center, are intended to help Tufts Medical Center/Tufts University researchers resolve questions about study design, statistics, and statistical software including Statistical Analysis System (SAS).

BERD Center Drop-In Sessions are free and staffed by Tufts CTSI epidemiologists and biostatisticians. They can help you tackle clinical research questions, such as:

  • Have I chosen the most efficient and valid study design to investigate this hypothesis?
  • How many people will I need in my study?
  • Which statistical test is appropriate?
  • Could loss of participants be a problem in my study, and how should I handle their missing data?
  • How can I best respond to an IRB stipulation/inquiry?

Research Process Improvement assistance is also available at Drop-in Sessions.

Drop-in Sessions take place every Wednesday from 8:00 – 9:00am at 35 Kneeland Street, 10th Floor Conference Room, Boston.

Drop-In Sessions
Research Help Drop-in Session

Drop-in Sessions, sponsored by the Biostatistics, Epidemiology, and Research Design (BERD) Center, are intended to help Tufts Medical Center/Tufts University researchers resolve questions about study design, statistics, and statistical software including Statistical Analysis System (SAS).

BERD Center Drop-In Sessions are free and staffed by Tufts CTSI epidemiologists and biostatisticians. They can help you tackle clinical research questions, such as:

  • Have I chosen the most efficient and valid study design to investigate this hypothesis?
  • How many people will I need in my study?
  • Which statistical test is appropriate?
  • Could loss of participants be a problem in my study, and how should I handle their missing data?
  • How can I best respond to an IRB stipulation/inquiry?

Research Process Improvement assistance is also available at Drop-in Sessions.

Drop-in Sessions take place every Wednesday from 8:00 – 9:00am at 35 Kneeland Street, 10th Floor Conference Room, Boston.

Drop-In Sessions
Research Help Drop-in Session

Drop-in Sessions, sponsored by the Biostatistics, Epidemiology, and Research Design (BERD) Center, are intended to help Tufts Medical Center/Tufts University researchers resolve questions about study design, statistics, and statistical software including Statistical Analysis System (SAS).

BERD Center Drop-In Sessions are free and staffed by Tufts CTSI epidemiologists and biostatisticians. They can help you tackle clinical research questions, such as:

  • Have I chosen the most efficient and valid study design to investigate this hypothesis?
  • How many people will I need in my study?
  • Which statistical test is appropriate?
  • Could loss of participants be a problem in my study, and how should I handle their missing data?
  • How can I best respond to an IRB stipulation/inquiry?

Research Process Improvement assistance is also available at Drop-in Sessions.

Drop-in Sessions take place every Wednesday from 8:00 – 9:00am at 35 Kneeland Street, 10th Floor Conference Room, Boston.