Clinical Lecture Series

Target audience

Health professionals working on human subjects research.

Educational objectives

Participants should be able to discuss the most current information and relevant approaches to research involving human subjects.

Purpose

To educate clinical research professionals on the basics of clinical research. There are also courses of interest on current and novel research. The lectures in this series will help provide a more effective, efficient and cohesive clinical research environment at the University of Iowa.

Fall 2024 Schedule

10/03/24 Noon-1:00 Pinkrose Hamilton- Chief Analytics Officer for UI Health Care Data Governance and QAQI Policies
11/07/24 Noon-1:00 Fozia Ghafoor CT.gov
12/05/24 Noon-1:00

Jessica Boyle, JD- Associate Director, Division of Sponsored Programs

Caitlin Flaherty- Senior Sponsored Research Specialist, Division of Sponsored Programs

Data Use Agreements vs. Material Transfer Agreements

Upcoming Lecture:

ICTS Clinical Lecture Series - Comprehensive Guidelines and Best Practices for Reporting Outcome Measures on ClinicalTrials.gov

Speaker: Fozia Ghafoor, MBBS, MS, ClinicalTrials.gov PRS Manager, Human Subjects Office

Date/Time: November 7, 2024, 12:00 PM – 1:00 PM

Location: Join Zoom Meeting

Objectives:

The research study outcome measure is an integral component of ClinicalTrials.gov registration and results reporting. Emphasizing the importance of precise and accurate description, the presentation will address the issue of inconsistency in reporting for different components of outcome measure and the submission of data with precision. The lecture will also offer essential guidelines and practical strategies aimed at ensuring compliance with the Food and Drug Administration Amendments Act (FDAAA 801) and ClinicalTrials.gov standards. Using case studies and best practices, attendees will gain valuable insights into effective reporting, ensuring adherence to regulatory requirements and contributing to the integrity of clinical research.

Key topics to be covered include:

  • Methodology for accurately describing research study outcome measures

  • Types of outcome measures

  • Required information for outcome measures during registration and results reporting

  • Common reporting mistakes, illustrated through case studies, along with strategies to avoid them

 

Continuing education credit

The University of Iowa Carver College of Medicine

Each session in this educational series for a maximum of 1.0 AMA PRA Category 1 Credit(s) TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

The University of Iowa College of Nursing

Full time attendance for this program will award 1.0 contact hours.

Contact information

If you have questions for presenters or suggestions for topics, please contact: Dori Hinson

 

Everyone in a position to control the content of this educational activity will disclose to the CME provider and to attendees all relevant financial relationships with any commercial interest. They will also disclose if any pharmaceuticals or medical procedures and devices discussed are investigational or unapproved for use by the U.S. Food and Drug Administration (FDA).

 

Help the Institute for Clinical and Translational Science at the University of Iowa continue making new strides in medical research by citing the NIH CTSA program grant UM1TR004403.