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: Nov. 7, 2024, noon–1 p.m.

Location: Join Zoom Meeting - https://uiowa.zoom.us/j/99048235645

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.

Professions: Nurse, Other, Social Worker