Study <Protocol Number> Analysis Data Reviewer’s Guide

Analysis Data Reviewer’s Guide

Version 0.1. March 10, 2014

<Sponsor Name>

Study Protocol Number

Analysis Data Reviewer’s Guide

Contents

1.Introduction

1.1Purpose

1.2Acronyms

1.3Study Data Standards and Dictionary Inventory

2.Protocol Description

2.1Protocol Number and Title

2.2Protocol Design

3.Analysis Issues Related to Multiple Analysis Datasets

3.1Comparison of SDTM and ADaM Content

3.2Core Variables

3.3Treatment Variables

3.4Subject Issues that Require Special Analysis Rules

3.5Use of Visit Windowing, Unscheduled Visits, and Record Selection

3.6Imputation/Derivation Methods

4.Analysis Data Creation and Processing Issues

4.1Source Data Used for ADaM Creation

4.2Split Datasets

4.3Data Dependencies

4.4Intermediate Datasets

4.5Variable Conventions

4.6Submission of Programs

5.Subject Data Description

5.1 Overview

5.2 ADaM Domains

5.2.1 ADSL – Subject Level Analysis Dataset

5.2.2 Dataset – Dataset Label

6.Data Conformance Summary

6.1 Conformance Inputs

6.2Issues Summary

1.Introduction

1.1Purpose

This document provides context for the analysis datasets and terminology that benefit from additional explanation beyond the Data Definitions document (define.xml). In addition, this document provides a summary of ADaM conformance findings.

1.2Acronyms

Acronym / Translation

1.3Study Data Standards and Dictionary Inventory

Standard or Dictionary / Versions Used
SDTM
ADaM
Controlled Terminology
Data Definitions
Medications Dictionary
Medical Events Dictionary
Other standards (optional)

2.Protocol Description

2.1Protocol Number and Title

Protocol Number:

Protocol Title:

Protocol Versions:

(Note herechanges in protocol amendments that affected data collection or interpretation)

2.2Protocol Design

(Graphic or text here to describe how the definition of standard ADaM variables for treatment, analysis period, analysis phase, etc relate to the design of the protocol)

3.Analysis Issues Related to Multiple Analysis Datasets

3.1Comparison of SDTM and ADaM Content

Are data for screen failures, including data for run-in screening (for example, SDTM values of ARMCD=’SCRNFAIL’, or ‘NOTASSGN’) included in ADaM datasets?

<Text here>

Is data taken from an ongoing study?

<Text here>

Additional Content of Interest

(See ADRG Completion Guidelines for additional content of interest, and include text here).

3.2Core Variables

Core variables are those that are represented across all/most analysis datasets.

Variable Name / Variable Label

3.3Treatment Variables

  • ARM versus TRTxxP

<The purpose of this section is to describe / contrast values of ARM vs. TRTxxP.>

  • ACTARM versus TRTxxA

<The purpose of this section is to describe / contrast values of ACTARM vs. TRTxxA. >

  • Use of ADaM Treatment Variables in Analysis

<The purpose of this section is to describe the use of planned and actual treatment variables in the analysis

3.4Subject Issues that Require Special Analysis Rules

(Text here)

3.5Use of Visit Windowing, Unscheduled Visits, and Record Selection

(Text here)

3.6Imputation/Derivation Methods

(Text here)

4.Analysis Data Creation and Processing Issues

4.1Source Data Used for ADaM Creation

(Text here)

4.2Split Datasets

(Text here)

4.3Data Dependencies

(Text here)

4.4Intermediate Datasets

(Text here)

4.5Variable Conventions

(Text here)

4.6Submission of Programs

(Text here)

Program inventory:

Program name / Output / Inputs / Macros used

5.Subject Data Description

5.1 Overview

  • Do the analysis datasets support all protocol specified objectives?
  • Include all objectives listed in the SAP which are not supported in the analysis datasets and the reason for their absence
  • Were the SDTM datasets used as sources for the analysis datasets?
  • Do the submission datasets include screen failures?

Additional Content of Interest

(See ADRG Completion Guidelines for additional content of interest, and include text here).

5.2 ADaM Domains

Dataset – Dataset Label / CLASS / Efficacy / Safety / Baseline or other subject characteristics / PK/PD / Primary Objective / Structure

5.2.1 ADSL – Subject Level Analysis Dataset

This section is required for the subject level analysis dataset.

5.2.2 Dataset – Dataset Label

6.Data Conformance Summary

6.1 Conformance Inputs

  • Were the analysis datasets evaluated for conformance with CDISC ADaM Validation Checks?

If yes:

  • Version of CDISC ADaM Validation Checks:
  • Specify software used:
  • OpenCDISC
  • Sponsor-defined
  • Other (describe)
  • Were the ADaM datasets evaluated in relation to define.xml?
  • Was define.xml evaluated?

6.2Issues Summary

Dataset / Diagnostic Message / Severity / Count / Explanation

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