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Study Data Standardization Plan
<Sponsor Name>
<Name of Product>
<Indication>
<IND>
Version ccyy-mm-dd
<Sponsor>: <Name of Product>: <Indication>: <IND>
SDSP
Study Data Standardization Plan Revision History
Version
Summary of Major Change(s) and Impact
Version 1.0
First approved version of Study Data Standardization Plan
Version x.x
<text here of changes>
Revision Date
ccyy-mm-dd
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SDSP
Study Data Standardization Plan
Contents
1.
Introduction........................................................................................................................................... 4
1.1
Purpose.......................................................................................................................................... 4
1.2
Scope ............................................................................................................................................. 4
1.3
Acronyms ...................................................................................................................................... 4
1.4
Definitions..................................................................................................................................... 5
2.
General Sponsor Information ................................................................................................................ 6
3.
Product Information .............................................................................................................................. 6
4.
List of Studies and Standards ................................................................................................................ 7
4.1
Nonclinical .................................................................................................................................... 7
4.2
Clinical .......................................................................................................................................... 8
4.3
Pooled Studies ............................................................................................................................. 11
5.
Non-Conformance to Supported Standards Justification .................................................................... 13
6.
FDA Data Standards Discussions ....................................................................................................... 14
7.
References........................................................................................................................................... 15
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SDSP
1. Introduction
1.1 Purpose
The purpose of the Study Data Standardization Plan (SDSP) is to establish and document a plan for
describing the data standardization approach for studies within a development program. The Study Data
Standardization Plan (Standardization Plan) assists FDA in identifying potential data standardization
issues early in the development program1.
1.2 Scope
The scope of this document is for use with FDA submissions only. After it has been approved for use, the
scope could expand to be used with other regulatory agencies after the proper discussions.
The SDSP is intended to include historical, current, and planned information about the development of
the compound and indication. Multiple plans are permissible within a compound. It will be updated and
maintained throughout the development of the compound, as new studies are planned or as the data
standardization strategy evolves.
Standards that are currently available in the Data Standards Catalog2 are the basis for which standards are
listed.
1.3 Acronyms
Acronym
Translation
ADaM
Analysis Data Model
FPV
First Patient Visit
ISE
Integrated Summary of Efficacy
ISS
Integrated Summary of Safety
LOINC
Logical Observation Identifiers Names and Codes
NDF-RT
National Drug File – Reference Terminology
SDSP
Study Data Standardization Plan
SDTM
Study Data Tabulation Model
SEND
Standard for Exchange of Nonclinical Data
SNOMED
Systematized Nomenclature of Medicine
TBD
To Be Determined
UNII
Unique Ingredient Identifiers
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Acronym
Translation
WHO-DD
WHO Drug Dictionary
SDSP
1.4 Definitions
Term
Planned Study
Ongoing
Study
Completed
Study
Nonclinical
Study Start
Date
Clinical
Nonclinical
& Clinical
Pooled
Definition
Study Start Date has not been achieved.
Study Start Date has been achieved and the study is not completed.
The final report has been signed by the study director. (Comparison
Chart of FDA, Environmental Protection Agency (EPA),
Organization for Economic Co-operation and Development
(OECD)3)
The date on which the protocol is signed by the study director. Also
known as Study Initiation Date. (Comparison Chart of FDA,
Environmental Protection Agency (EPA), Organization for Economic
Co-operation and Development (OECD)3)
CDISC SEND Controlled Terminology, STSTDTC5)
No Electronic
Data
Study data is not available electronically.
Planned Study
Study Start Date has not been achieved.
Ongoing
Study
1 or more patients is enrolled in the clinical trial4 and the study is not
completed.
Completed
Study
The final subject was examined or received an intervention for the
purposes of final collection of data for the primary outcome, whether
the clinical trial concluded according to the prespecified protocol or
was terminated.4
Study Start
Date
The earliest date of informed consent among any subject (Date/Time
of Informed Consent, RFICDTC) that enrolled in the study. For
studies conducted without informed consent (ie. emergency use) use
the date of treatment. Dates for subjects who were screen failures are
not included. (CDISC SDTM Controlled Terminology, SSTDTC6)
Legacy Data
Study data that does not conform to the standards by the date of
requirement specified in the published Data Standards Catalog2.
Current
Study data from more than one study has been pooled/integrated.
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SDSP
Term
Definition
Planned
Study data from more than one study will be pooled/integrated..
Studies
Up-version
The version of the Exchange Standards and/or Technology Standards was transformed
for the study or pool.
2. General Sponsor Information
Name of Product
Indication
IND
Sponsor Name
Sponsor Contact
Sponsor Contact Email
3. Product Information
Describe the product under development, its intended indication(s), and patient populations.
(Text here)
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SDSP
4. List of Studies and Standards
4.1 Nonclinical
Study
Identifier Brief Title
Study Type
REPEAT DOSE TOXICITY
Study Status
COMPLETED
PRIMARY
PHARMACODYNAMICS
ONGOING
PHARMACODYNAMIC DRUG
INTERACTIONS
PHARMACOKINETIC DRUG
INTERACTIONS
PLANNED
Study Start
Exchange
Terminology
Date
Standards
Standards
Sponsor Defined
ccyy-mm-dd
LEGACY
<(forecasted
Terminology
Protocol sign)> SDTM v<version>/
SEND IG <version> CDISC SEND
Terminology
tumor.xpt
<date>
ts.xpt
NONE
define.xml<version>
(Please see Completion Guidelines
for more information)
No Electronic Data
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SDSP
4.2 Clinical
Study
Study Start
Exchange
Terminology
Identifier Brief Title
Study Design
Study Status
Date
Standards
Standards
<Phase <x>> <Interventional/Observational/Expanded Access> Studies - <indication or Healthy Subjects or Healthy Volunteers>
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Study
Identifier Brief Title
Study Design
Interventional:
Allocation,
Control Group,
Intervention Model,
Masking,
Trial Type Response,
Primary Purpose
Observational:
Observational Study Model,
Time Perspective,
Biospecimen Retention,
Enrollment,
Target Follow-Up
Duration,
Number of Groups/Cohorts
Expanded Access:
None – This column is
blank
Refer to clinicaltrials.gov
study design permissible
values7
If values are unknown,
leave blank or specify TBD
Please See Completion
Guidelines for more
information
Study Status
COMPLETED
SDSP
Study Start
Date
ccyy-mm-dd
<(forecasted FPV)>
Exchange
Standards
ANALYSIS
LEGACY
Terminology
Standards
Sponsor Defined
Terminology
ONGOING
PLANNED
ADaM v<version>/ CDISC SDTM
ADaM IG <version> Terminology
<date>
ADaM
define.xml <version>
MedDRA
(Adverse
TABULATIONS Events/Medical
LEGACY
History/<other>)
<version>
SDTM v<version>/
SDTM IG <version>
WHO-DD
(Medications)
SDTM
<version>
define.xml <version>
LOINC
Up-version<ed> (Lab Test Term)
< ccyy-mm-dd>/
<version>
<TBD>/
SNOMED CT
<pooled>
(Indication)
<indicate here what
<version>
was or is planned to
be up-versioned>
NDF-RT
(Pharm Class)
<version>
UNII
(Active moiety)
<version>
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Study
Identifier Brief Title
Study Design
Study Status
SDSP
Study Start
Date
Exchange
Standards
Terminology
Standards
Up-version<ed>
< ccyy-mm-dd>/
<TBD>/
<pooled>
<indicate here
what was or is
planned to be upversioned>
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SDSP
4.3 Pooled Studies
Data Pool
Identifier
Data Pool
(List of Studies)
Pool
Pool Description
Status
CURRENT ISS <any additional information, such as certain
domains>
PLANNED
ISE <any additional information, such as certain
domains>
Exchange
Standards
ANALYSIS
LEGACY
Terminology
Standards
CDISC SDTM
Terminology
<date>
ADaM v<version>/
ADaM IG <version> MedDRA (Adverse
Events/ Medical
ADaM
History/<other>)
define.xml <version>
<version>
TABULATIONS
LEGACY
SDTM v<version>/
SDTM IG <version>
SDTM
define.xml <version>
Up-version<ed>
<ccyy-mm-dd>/
<TBD>
<indicate here what
was or is planned to be
up-versioned>
WHO-DD
(Medications)
<version>
LOINC
(Lab Test Term)
<version>
SNOMED CT
(Indication)
<version>
NDF-RT
(Pharm Class)
<version>
UNII
(Active moiety)
<version>
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Data Pool
Identifier
Data Pool
(List of Studies)
Pool
Status
Pool Description
SDSP
Exchange
Standards
Terminology
Standards
Up-version<ed>
<ccyy-mm-dd>/
<TBD>
<indicate here what
was or is planned to
be up-versioned>
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SDSP
5. Non-Conformance to Supported Standards Justification
Study Identifier
Expected Standard
Provided Standard
Justification for Non-Conformance to Standards
(including Exception Information)
SDTM v <version>/
SEND IG <version>
SEND
define.xml <version>
SDTM v<version>/
SDTM IG <version>
SDTM
define.xml <version>
ADaM v <version>/
ADaM IG <version>
ADaM
define.xml <version>
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SDSP
6. FDA Data Standards Discussions
Date of
Discussion
ccyy-mm-dd
Meeting
Identifier
Form of Discussion Result/Agreement
Teleconference
(Text here)
Face-to-face
Email
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SDSP
7. References
1
Study Data Technical Conformance Guide
[http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm]
2
Data Standards Catalog
[http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm]
3
Comparison Chart of FDA, Environmental Protection Agency (EPA), Organization for Economic
Co-operation and Development (OECD)
[http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring]
4
US Public Law 110-85, Title VIII, Section 801
[http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf]
5
CDISC SEND Controlled Terminology
[http://evs.nci.nih.gov/ftp1/CDISC/SEND]
6
CDISC SDTM Controlled Terminology
[http://evs.nci.nih.gov/ftp1/CDISC/SDTM]
7
clinicaltrials.gov Study Design Terminology
[https://prsinfo.clinicaltrials.gov/definitions.html#StudyDesign]
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