Legacy Data Conversion Plan
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<Compound Name>
Version 2016-02-08xx-xx
<Compound Name>
Legacy Data Conversion Plan
Legacy Data Conversion Plan
Contents
1.
Introduction........................................................................................................................................... 3
1.1
Purpose.......................................................................................................................................... 3
1.2
Acronyms ...................................................................................................................................... 3
1.3
Study Data Standards and Dictionary Inventory ......................... Error! Bookmark not defined.
2.
Protocol Description ........................................................................... Error! Bookmark not defined.
2.1
Protocol Number and Title.......................................................... Error! Bookmark not defined.
2.2
Protocol Design ........................................................................... Error! Bookmark not defined.
2.3
Trial Design Datasets .................................................................. Error! Bookmark not defined.
2.3.1.
TA – Trial Arms.................................................................. Error! Bookmark not defined.
2.3.2.
TE – Trial Elements ............................................................ Error! Bookmark not defined.
2.3.3.
TV – Trial Visits ................................................................. Error! Bookmark not defined.
2.3.4.
TI – Trial Inclusion/Exclusion Criteria ............................... Error! Bookmark not defined.
2.3.5.
TS – Trial Summary ............................................................ Error! Bookmark not defined.
3.
Subject Data Description .................................................................... Error! Bookmark not defined.
3.1
Overview ..................................................................................... Error! Bookmark not defined.
3.2
Annotated CRFs .......................................................................... Error! Bookmark not defined.
3.3
SDTM Subject Domains ............................................................. Error! Bookmark not defined.
3.3.1.
AE – Adverse Events .......................................................... Error! Bookmark not defined.
3.3.2.
DS – Disposition ................................................................. Error! Bookmark not defined.
3.3.3.
EX – Exposure .................................................................... Error! Bookmark not defined.
3.3.4.
Dataset – Dataset Label....................................................... Error! Bookmark not defined.
4.
Data Conformance Summary.............................................................. Error! Bookmark not defined.
4.1
Conformance Inputs .................................................................... Error! Bookmark not defined.
4.2
Issues Summary .......................................................................... Error! Bookmark not defined.
4.3
Additional Conformance Details ................................................ Error! Bookmark not defined.
Appendix I: Inclusion/Exclusion Criteria ..................................................................................................... 6
Appendix II: Conformance Issues Details .................................................................................................... 7
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Legacy Data Conversion Plan
1. Introduction
1.1 Purpose
This document provides context for the conversion of raw data to standardized data for <submission,
pre-NDA>. In addition, this document summarizes the conversion results along with any issues
encountered and the resolution of the issues. Any outstanding issues will also be summarized.
1.2 Acronyms
Acronym
Translation
2. Legacy Data Summary
Identify studies included and phase
Assumptions on the data – such as, could only convert some of the data
Was data converted from actual datasets or did it have to be entered manually from the CRF into the
data entry system? Did a vendor manually enter the data?
Any translations from non-English to English? (Protocol, CSR, data)
Type of validation run on the legacy data, particularly on data that had to be entered manually (such
as double data entry, controls, etc.)
Were all SDTM domains created or a subset such as safety or efficacy? Was all data converted?
Phase I sometimes only requires that a subset of the data is submitted. Was this done? For example,
for the following studies only the following domains were created: AE, EX, etc.
Point to where more information can be found (such as SDSP, SDRG)
3. Converted Data Summary
Include text on the process for how the data was converted, including version of SDTM.
Data converted that could affect CSR, such as race.
Could include diagram as well as text.
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Legacy Data Conversion Plan
Mention if upcode data, such as MedDRA version or WhoDRUG version plus other dictionaries if
applicable. Refer to SDRG for more information.
Dictionaries used, such as converting lab test codes to text.
Mention if saved raw data in supplemental domains.
How was the SDTM data validated aside from Open CDISC? Were reports run to ensure numbers
match the CSR from the analysis datasets that were created by the sponsor?
Was raw data submitted or bridging document created?
Is ADaM created from the SDTM or were these ‘dead end’ conversions? Was analysis rederived
based on the SDTM?
Was controlled terminology followed from legacy to SDTM? Was it updated to a particular version
of controlled terminology?
What type of data standards were used in addition to controlled terminology? For example, if there
are 1’s and 0’s used for Yes and No. Body systems, too. Didn’t match current SOC but had to
rename in SDTM.
4. Conversion Results
If common theme, provide it here. For example, if certain trial domains were not created or if SDTM
domains could not be fully populated. Or if certain SDTM required variables, such as EPOCH, could
not be populated. Refer to SDRG for more details.
Table with old variable name, SDTM name, comments (include data collected but not converted).
Sounds like a bridging document from raw data to SDTM. If don’t send raw data, is this meaningful?
Refer to SDRG for open CDISC issue summary.
Look at .2 of Mario’s example.
Issues Encountered and Resolved
Issue
Resolution
Comments
Outstanding Issues
Issue
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Comments
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Issue
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Comments
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Study Data Reviewer’s Guide
<Compound Name>
Appendix I: Conversion Matrix
CRF Page (?)
Raw Dataset
Standard or Dictionary
SDTM Domain
Comments
Version
SDTM
Controlled Terminology
Medications Dictionary
Medical Events Dictionary
Other standards (optional)
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<Compound Name>
Study Data Reviewer’s Guide
Appendix II: Issues Details
(Text here)
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