Study <Protocol Number>Study Data Reviewer’s Guide

Study Data Reviewer’s Guide

<Sponsor Name>

Study <Protocol Number>

Study 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

2.3Trial Design Datasets

2.3.1TA – Trial Arms

2.3.2TE – Trial Elements

2.3.3TV – Trial Visits

2.3.4TI – Trial Inclusion/Exclusion Criteria

2.3.5TS – Trial Summary

3.Subject Data Description

3.1Overview

3.2Annotated CRFs

3.3SDTM Subject Domains

3.3.1AE – Adverse Events

3.3.2DS – Disposition

3.3.3EX – Exposure

3.3.4Dataset – Dataset Label

4.Data Conformance Summary

4.1Conformance Inputs

4.2Issues Summary

4.3Additional Conformance Details

Appendix I: Inclusion/Exclusion Criteria

Appendix II: Conformance Issues Details

1.Introduction

1.1Purpose

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

1.2Acronyms

Acronym / Translation

1.3Study Data Standards and Dictionary Inventory

Standard or Dictionary / Versions Used
SDTM
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 here changes in protocol amendments that affected data collection or interpretation)

2.2Protocol Design

(Graphic or text here, or delete this section)

2.3Trial Design Datasets

Are Trial Design datasets included in the submission?

(If no, delete the remainder of this section. If yes, refer to SDRG Completion Guidelines Section 2.3 and provide additional information below.)

2.3.1TA – Trial Arms

(Text here)

2.3.2TE – Trial Elements

(Text here)

2.3.3TV – Trial Visits

(Text here)

2.3.4TI – Trial Inclusion/Exclusion Criteria

(If criteria are not fully described in TI, complete Appendix I: Inclusion/Exclusion Criteria or hyperlink to the pages in blankcrf.pdf that contain the full criteria text. Delete these instructions.)

2.3.5TS – Trial Summary

(Text here)

3.Subject Data Description

3.1Overview

Are the submitted data taken from an ongoing study?

If yes, describe the data cut or database status:

(Text here)

Were the SDTM datasets used as sources for the analysis datasets?

If no, what were the sources of analysis datasets?

(Text here. Include the following text: Please refer to Section 5 for details: Legacy Data Conversion Plan and Report)

Do the submission datasets include screen failures?

If yes, which datasets include screen failure data?

(Text here)

Were any domains planned, but not submitted because no data were collected?

If yes, list domains not submitted:

(Text here)

Are the submitted data a subset of collected data?

If yes, describethe reason that all collected data were not provided:

(Text here)

Additional Content of Interest

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

3.2Annotated CRFs

(Text here)

3.3SDTM Subject Domains

Dataset – Dataset Label / Efficacy / Safety / Other / SUPP- / Related Using RELREC / Observation Class
AE – AdverseEvents / X / Events
DM – Demographics / X / Special Purpose
DS – Disposition / X / Events
EX – Exposure / X / Interventions
3.3.1AE – Adverse Events

(Text and/or supplemental qualifier inventory here)

3.3.2DS – Disposition

(Text and/or supplemental qualifier inventory here)

3.3.3EX – Exposure

(Text and/or supplemental qualifier inventory here)

3.3.4Dataset – Dataset Label

(Text here)

QNAM / Description

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4.Data Conformance Summary

4.1Conformance Inputs

Was OpenCDISC used to evaluate conformance?

If yes, specify the versions of OpenCDISC and the OpenCDISC validation rules:

(Text here)

Were sponsor-defined validation rules used to evaluate conformance?

If yes, describe any significant sponsor-defined validation rules:

(Text here)

Were the SDTM datasets evaluated in relation to define.xml?

Was define.xml evaluated?

Provide any additional compliance evaluation information:

(Text here)

4.2Issues Summary

Dataset / Diagnostic Message / Severity / Count / Explanation

4.3Additional Conformance Details

(Complete table below or delete this section)

Dataset / Diagnostic Message / Severity / Count / Explanation

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5.Legacy Data Conversion Plan & Report

5.1 Conversion Data Flow

The legacy data was converted to SDTM as described in the following data flow diagram.

(Insert data flow diagram starting with collection through through analysis – forward arrow)

Rationale:

(Text here)

5.2 Converted Data Summary

(Text here)

5.2.1 Issues Encountered and Resolved
  • (Text here)
  • (Text here)

5.3Traceability Data Flow

(Insert data flow diagram showing traceability forwards and backwards from collection to submission)

5.4Outstanding Issues

  • (Text here)
  • (Text here)

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Appendix I: Inclusion/Exclusion Criteria

Protocol/Amendment Version / Category / IETESTCD / Full Text of Criterion

Appendix II: Conformance Issues Details

(Text here or delete this section)

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