<Sponsor>: <Name of Product>: <Indication>: <IND> SDSP

Study Data Standardization Plan

<Sponsor Name>

Name of Product

Indication

<IND>

Approved SDSP Content Version ccyy-mm-dd

SDSP Template Version ccyy-mm-dd

CBER Appendix Version ccyy-mm-dd

Study Data Standardization Plan Revision History

Version / Summary of Major Change(s) and Impact / Revision Date
Version 1.0 / First approved version of Study Data Standardization Plan / ccyy-mm-dd
Version x.x / <text here of changes>


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 10

5. Non-Conformance to Supported Standards Justification 11

6. FDA Data Standards Discussions 12

7. References 14

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. This template will be submitted to in CDER and CBER to document study standards. 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. It will be shared with regulatory agencies at key regulatory interactions and when deemed necessary by the sponsor., 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.

Only single dose, repeat dose, and carcinogenicity nonclinical studies are in scope as those adhere to SEND Exchange Standards.

For nonclinical studies which are in scope of the applicable standard(s) in the Data Standards Catalog, this SDSP provides information about the studies completed and planned at the time of the initial IND application and the NDA application. Updates to SDSP are not required for nonclinical studies between the IND filing and NDA filing but similar content updates can be made whenever deemed necessary by the sponsor, utilizing this SDSP template or in an other manner of communication (sponsor-specific).

1.3 Acronyms

Acronym / Translation /
ADaM / Analysis Data Model
FDA / Food and Drug Administration
IG / Implementation Guide
ISE / Integrated Summary of Efficacy
ISS / Integrated Summary of Safety
LOINC / Logical Observation Identifiers Names and Codes
MedDRA / Medical Dictionary for Regulatory Activities
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
STSTDTC / Study Initiation Date;Study Start Date
SSTDTC / Study Start Date
TBD / To Be Determined
UNII / Unique Ingredient Identifiers
WHO-DD / WHO Drug Dictionary

1.4  Definitions

/ Term / Definition /
Nonclinical / Planned Study / Study Start Date has not been achieved.
Ongoing Study / Study Start Date has been achieved and the study is not completed.
Completed Study / 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)
Study Start Date / 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, STSTDTC4)
No Electronic Data / Study data is not available electronically.
Legacy Data / Still under construction with nonclinical.
Clinical / Planned Study / Study Start Date has not been achieved.
Ongoing Study / 1 or more patients is enrolled in the clinical trial5 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.5
Study Start Date / The earliest date of informed consent among any subject that enrolled in the study. For example, see Study Start Date in the SDTM Trial Summary Domain (TSPARMCD = SSTDTC).6
Legacy Data / Study data that does not conform to the standards by the date of requirement specified in the published Data Standards Catalog.2
Pooled Studies / Current / Study data from more than one study has been pooled/integrated.
Planned / Study data from more than one study will be pooled/integrated.
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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<Sponsor>: <Name of Product>: <Indication>: <IND> SDSP

4.  List of Studies and Standards

4.1  Nonclinical

Study Identifier / Brief Title / Study Type / Study Status / Study Start
Date / Exchange Standards / Terminology Standards
SINGLE DOSE TOXICITY
REPEAT DOSE TOXICITY
CARCINOGENICITY
REPEAT DOSE TOXICITY
PRIMARY PHARMACODYNAMICS
PHARMACODYNAMIC DRUG INTERACTIONS
PHARMACOKINETIC DRUG INTERACTIONS
(Please see Completion Guidelines for more information) / COMPLETED
ONGOING
PLANNED / ccyy-mm-dd
(forecasted Protocol sign) / LEGACY
SDTM v<version>/
SEND IG <version>
tumor.xpt
ts.xpt
define.xml<version>
No Electronic Data / Sponsor Defined
Terminology
CDISC SEND
Terminology
<date>
NONE

4.2  Clinical

Study Identifier / Brief Title / Study Design / Study Status / Study Start
Date / Exchange Standards / Terminology Standards
Phase <x> <Interventional/Observational/Expanded Access> Studies - <indication or Healthy Subjects or Healthy Volunteers
Please See Completion Guidelines for more information
If values are unknown, leave blank or specify TBD / COMPLETED
ONGOING
PLANNED / ccyy-mm-dd
(forecasted Informed Consent) / ANALYSIS LEGACY
ADaM v<version>/
ADaM IG <version>
ADaM
define.xml <version>
TABULATIONS
LEGACY
SDTM v<version>/
SDTM IG <version>
SDTM
define.xml <version>
Up-versioned
ccyy-mm-dd>/
<TBD>/
<pooled>
<indicate here what was or is planned to be up-versioned> / Sponsor Defined
Terminology
CDISC SDTM
Terminology
<date>
MedDRA
(Adverse Events/
Medical History/
<other>)
Initial <version>
Final <version>
WHO-DD
(Medications)
<version>
LOINC
(Lab Test Term)
<version>
SNOMED CT
(Indication)
<version>
NDF-RT
(Pharm Class) <version>
UNII
(Active moiety) <version>
Up-version<ed
< ccyy-mm-dd>/
<TBD>/
<pooled>
<indicate here what was or is planned to be up-versioned>

4.3  Pooled Studies

Data Pool Identifier / Data Pool
(List of Studies) / Pool
Status / Pool Description / Exchange
Standards / Terminology Standards
CURRENT
PLANNED / ISS <any additional information, such as certain domains>
ISE <any additional information, such as certain domains> / ANALYSIS
LEGACY
ADaM v<version>/
ADaM IG <version>
ADaM
define.xml <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> / Sponsor Defined
Terminology
CDISC SDTM
Terminology
<date>
MedDRA
(Adverse Events/
Medical History/
<other>)(Adverse Events/ Medical History/<other>)
Initial <version>
Final <version>
WHO-DD
(Medications)
<version>
LOINC
(Lab Test Term)
<version>
SNOMED CT
(Indication)
<version>
NDF-RT
(Pharm Class) <version>
UNII
(Active moiety) <version>
Up-version<ed
ccyy-mm-dd/
<TBD>
<indicate here what was or is planned to be up-versioned>

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>

6.  FDA Data Standards Discussions

Date of
Discussion / Meeting
Identifier / Form of Discussion / Result/Agreement
ccyy-mm-dd / Teleconference
Face-to-face
Email / (Text here)

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<Sponsor>: <Name of Product>: <Indication>: <IND> 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 CDISC SEND Controlled Terminology

[http://evs.nci.nih.gov/ftp1/CDISC/SEND]

5 US Public Law 110-85, Title VIII, Section 801

[http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf]

6 Providing Regulatory Submissions In Electronic Format — Standardized Study Data

[https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292334.pdf]

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