Study Data Reviewer S Guide

STUDY TITLE
<Study ID>

Study Data Reviewer’s Guide

Nonclinical

STUDY TITLE
Study ID

SPONSOR NAME

SPONSOR ADDRESS

CONTENTS

STUDY TITLE <Study ID>

1.SDRG Introduction

1.1Study Protocol Title, Number, and Version

1.2Summary of SEND Dataset Creation Process

1.3SEND Dataset Verification

2.Study Design

2.1Study Design Summary

2.2Trial Design Domain Overview

3.Standards, Formats, and Terminologies and their Versions

3.1Standards Used

3.2Rationale for Standards Selection

3.3Nonstandard Terminology

4.Description of Study Datasets

4.1Dataset Summary

4.2Dataset Explanation

4.2.1EX-Exposure......

4.3Use of Supplemental Qualifiers

5.Data Standards Validation Rules, Versions, and Conformance Issues

5.1Validation Outcome Summary

5.2FDA SEND Validation Rules Version

5.3Errors

5.4Warnings

6.Sponsor Decisions Related to Data Standard Implementations

6.1Sponsor Defined Standardization Descriptions

6.2Differences between SEND Datasets and Study Report

6.3Nonstandard Electronic Data Submitted

6.4Legacy Data Conversion

1.SDRG Introduction

1.1Study Protocol Title, Number, and Version

Study Title
Study Number
Study Version

1.2Summary of SEND Dataset Creation Process

1.3SEND Dataset Verification

2.Study Design

2.1Study Design Summary

(text here, if needed)

Number of Animals
Group / Treatment / Dose
Level / Dose Concentration / Dose
Volume / Main / TK
Terminal / Recovery / Main
mg/kg/day / mg/mL / mL/kg / Male / Female / Male / Female / Male / Female

2.2Trial Design Domain Overview

The following diagram illustrates the trial design.

(note: table format is dependent on trial design; add or delete rows as needed.)

Study Group / Trial Arms / Element in each Epoch / Trial Set
SPGRPCD / ARMCD / ARM / <EPOCH name 1> / <EPOCH name 2> / <EPOCH name 3> / SETCD / SET
<Sponsors group no.> / <Set name 1>
<Set name 2
<Set name 3

3.Standards, Formats, and Terminologies and their Versions

3.1Standards Used

Standard or Dictionary / Standard or Dictionary / Versions Used
Tabulation Datasets / CDISC SEND
Controlled Terminology / CDISC SEND Controlled Terminology
Data Definition file / CDISC DEFINE.XML

3.2Rationale for Standards Selection

The standards versions listed were compatible with supported versions in the Study Data Catalog, at the time of dataset creation.

The Technical Conformance Guide version xxxxx was used as a reference.

3.3Nonstandard Terminology

The following nonstandard terminology was used:

Dataset Name / Variable / Codelist / Term Used / Meaning

4.Description of Study Datasets

4.1Dataset Summary

Dataset Name / Dataset Label / Supplemental Qualifiers? / Related Records? / Observation Class
TS / Trial Summary / Trial Design
TE / Trial Elements / Trial Design
TA / Trial Arms / Trial Design
TX / Trial Sets / Trial Design
CO / Comments / Special Purpose
DM / Demographics / Special Purpose
SE / Subject Elements / Special Purpose
EX / Exposure / Interventions
DS / Disposition / Events
BW / Body Weight / Findings
BG / Body Weight Gain / Findings
CL / Clinical Observations / Findings
FW / Food and Water Consumption / Findings
LB / Laboratory Test Results / Findings
MA / Macroscopic Findings / Findings
MI / Microscopic Findings / Findings
OM / Organ Measurements / Findings
PC / Pharmacokinetic Concentrations / Findings
PP / Pharmacokinetic Parameters / Findings
RELREC / Related Records / Relationship
POOLDEF / Pooled Definition / Relationship

4.2Dataset Explanation

4.2.1EX-Exposure

(EX domain is an example. Text or table here for further description per data set, as needed)

4.3Use of Supplemental Qualifiers

Dataset Name / Associated Dataset / Qualifiers Used

5.Data Standards Validation Rules, Versions, and Conformance Issues

5.1Validation Outcome Summary

(text here)

5.2FDA SEND Validation Rules Version

Rule conformance to SEND 3.0 was evaluated using xxxxx version N.x, which includes checks for conformance against the FDA Specific SEND Validation Rules, Version Y.x.