Future of Case Report Tabulation Submissions

10/7/2003


Click here to start


Table of Contents

Future of Case Report Tabulation Submissions

Overview

What are Case Report Tabulations?

CRT Data Presentations

Why Standards?

Efficient Review Environment

Study Data Standards Goals

Study Data Models

Terminology Standards Initiatives

Content Standards

Patient Profile Pilot

Study Data and Data Definition Standard

Use of Study Data

Use of Study Data

Management of Data

PPT Slide

Study Data Submission Transition Milestones

Electronic Datasets

Replace Subject Profiles

Replace Data Listings

PPT Slide

PPT Slide

Author: LEVINR

Home Page: http://www.fda.gov/cder/regulatory/ersr/default.htm

Download presentation source