CSRC Event Details

Upcoming Events

January 22, 2020

Driving Efficiencies in Clinical Trials through the use of Cardiac Biomarkers

Location: FDA White Oak Campus
Date: Wednesday, January 22, 2020

Meeting Objectives:

  1. Crystallize the key issues discussed and disseminate them to public view through peer review literature
  2. Discuss and develop key endpoints/outcomes of future pragmatic clinical research programs

Rates:
CSRC Members: $625.00 | Non Members: $975.00 | Non profits: $250.00

View the draft agenda.

Register here.

Book your hotel at our group rate.

 

 


 Ongoing

Webinar: Technical Specifications for Submitting Data for QT Studies 

Access the webinar here: https://bit.ly/2KTGa7P

Scroll down the page and click "Watch Webinar" to view the presentation.

Topics Covered

  • Assessment of the drug effect in QT interval (and other ECG intervals) in dedicated thorough QT and early phase clinical studies and challenges with how data are currently submitted
  • Overview of the QT Studies Technical Specifications Document
  • Formatting study data for crossover, parallel and other study designs common in QT assessment using the QT Studies Technical Specifications Document
  • Standardized analysis using datasets formatted following the QT Studies Technical Specifications Document

Learning Objectives

  • Distinguish the main components of the QT Studies Technical Specifications Document (TSD) for datasets from QT/ECG studies and their relationship with how data are currently submitted
  • Create QT Studies TSD compliant datasets from the study raw data sources (e.g., from SDTM to ADSL, ADPC, and ADEG)
  • Demonstrate how to use datasets following the QT Studies TSD to perform by-time, concentration-QT and categorical outlier analyses in accordance with the ICH E14 guideline