1. Research Study Data Standards Standards for research study data for submission to regulatory authorities Standard development divided into three parts: –Study data information model –Controlled terminology –Content

2. Study Data Information Model Concepts –Observations are information collected in a study –Observations are described by 4 types of variables or parameters –Domains are a collection of observations related to a specific subject matter –Tabulation datasets are flat files with one observation per row and descriptive variables in the columns –Data definition is a description of the descriptive variables for the observations

3. Describe Observations Subject 101A Unique Subject Identifier variable Topic variable Timing variableQualifier variable nauseahad mildstarting on study day 6

4. Observations in the Data Tabulation Observation Subject identifier TopicTiming Qualifier Adverse event Unique subject Identification Actual start study day Severity Nausea101A6mild Observation Dizziness20312severe Description

5. Study Data Standards Controlled Terminology Adverse event Unique subject Identification Actual start study day Severity Nausea101A6mild Dizziness20312severe MedDRA Preferred Term Defined lexicon for specific variables Example - MedDRA for adverse event names Established standards for source of controlled terminology

6. Study Data Standards Data Content Standards Information that should be collected in a specific clinical or animal study Example –Demographics for clinical trials age race sex

7. Study Data Information Model Types of observations: –Interventions –Events –Findings Descriptive variables based on CDISC submission data standard version 2.0 Data definition based on CDISC metadata model and FDA guidance to industry

8. Study Data Information Model Does not include: –Controlled terminology –Content Does not cover other data submissions –Data listings –Analysis datasets –Subject profiles