SDSP, Inc. SDSP-001 Asthma 99999SDSP

SDSP, Inc. SDSP-001 Asthma 99999SDSP

Study Data Standardization Plan

SDSP, Inc.

SDSP-001

Asthma

99999

Version 2017-01-01

Example Purpose:

The purpose of this document is to provide an example for industry of an SDSP document for a drug program entering into Phase 3 with 2 safety and efficacy studies, two phase 2 ongoing studies, and several legacy PK studies.

Date / Updated Section(s) / Description of Changes
2017-01-01 / New Document
2017-01-15 / 4.2 / Study ID (SDSP-001-09) – Exchange and Terminology Standards updated:
SDTM v1.2/IG 3.1.2 up-versioned to SDTM v1.3/IG 3.1.3
SDTM define xml 1.0 up-versioned to SDTM define xml 2.0

Compound SDSP Revision History

Study Data Standardization Plan

Contents

1.Introduction

1.1Purpose

1.2Scope

1.3Acronyms

1.4Definitions

2.General Sponsor Information

3.Product Information

4.List of Studies and Standards

4.1Nonclinical

4.2Clinical

4.3 Integrated Studies

5.Non-Conformance to Supported Standards Justification

6.FDA Data Standards Discussions

7.References

1.Introduction

1.1Purpose

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.

1.2Scope

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.

1.3Acronyms

Acronym / Translation
ADaM / Analysis Data Model
FPV / First Patient Visit
ISE / Integrated Summary of Efficacy
ISS / Integrated Summary of Safety
SDSP / Study Data Standardization Plan
SDTM / Study Data Tabulation Model
SEND / Standard for Exchange of Nonclinical Data
TBD / To Be Determined
WHO-DD / WHO Drug Dictionary

1.4Definitions

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, STSTDTC5)
No Electronic Data / Study data is not available electronically.
Clinical / 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)
Nonclinical & Clinical / Legacy Data / Study data that does not conform to the standards by the date of requirement specified in the published Data Standards Catalog2.
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 / SDSP-001
Indication / Asthma
IND / 99999
Sponsor Name / SDSP, Inc.
Sponsor Contact / First Lastname
Sponsor Contact Email /

3.Product Information

Describe the product under development, its intended indication(s), and patient populations.

SDSP-001 is a small molecule currently under clinical development for the treatment of asthma in adults. It is a once daily controlled release capsule. Studies were conducted in asthma and COPD to support an asthma indication.

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4.List of Studies and Standards

4.1Nonclinical

Study Identifier / Brief Title / StudyType / StudyStatus / StudyStart
Date / ExchangeStandards / TerminologyStandards
Tox-1221 / Effects on Cardiovascular System in Conscious Dogs with subcutaneous dosing of Compound X / REPEAT DOSE TOXICITY / COMPLETED / 1992-12-01 / No Electronic Data / NONE
Tox-1234 / Modified Irwin test and effect on body temperature following single oral administration in the rat / TOXICOKINETICS / COMPLETED / 1993-02-09 / No Electronic Data / NONE
Tox-1235 / A single-dose toxicity oral toxicity study of Compound X in Dogs / SINGLE DOSE TOXICITY / COMPLETED / 1995-02-02 / LEGACY
define.xml 1.0 / Sponsor Defined
Terminology
Tox-1437 / A four-week oral toxicity study with compound X in rats followed by a four-week recovery period / PHARMACOKINETIC DRUG INTERACTIONS / COMPLETED / 1999-03-20 / LEGACY
define.xml 1.0 / Sponsor Defined
Terminology
Tox-1489 / A thirteen-week oral toxicity study with compound X in rats followed by an eight-week recovery period / REPEAT DOSE TOXICITY / COMPLETED / 2006-05-28 / LEGACY
define.xml 1.0 / Sponsor Defined
Terminology
Tox-1490 / A thirteen-week oral toxicity study with compound X in dogs followed by an eight-week recovery period / REPEAT DOSE TOXICITY / COMPLETED / 2009-06-21 / SDTM V1.2/
SEND IG 3.0
define.xml 1.0 / Sponsor Defined
Terminology
Tox-1577 / A six-month oral toxicity study with compound X in rats followed by a two-month recovery period / REPEAT DOSE TOXICITY / COMPLETED / 2011-11-23 / SDTM V1.2/
SEND IG 3.0
define.xml 1.0 / CDISC SEND Terminology 2011-06-05
Tox-1578 / A nine-month oral toxicity study with compound X in dogs followed by a three-month recovery period / ANALYTICAL METHODS AND VALIDATION REPORTS / COMPLETED / 2011-12-01 / SDTM v1.2/
SEND IG 3.0
ts.xpt
define.xml 1.0 / CDISC SEND Terminology 2011-07-22
TBD / A two-year dietary admix carcinogenicity study in mice with Compound X / CARCINOGENICITY / PLANNED / 2Q 2016
<forecasted Protocol sign> / TBD / TBD

4.2Clinical

Study Identifier / Brief Title / StudyDesign / StudyStatus / Study Start
Date / ExchangeStandards / TerminologyStandards
Phase 1 Interventional Studies - Healthy Subjects
SDSP-001-01
ABC- / Food Effect in Healthy Subjects / Nonrandomized,
Control None,
Single Group,
Open Label,
Pharmacokinetic,
Basic Science / COMPLETED / 2001-03-01 / ANALYSIS
LEGACY / COSTART
(Adverse Events)
5th Ed.
SDSP-001-02 / Food Bioavailability in Healthy Subjects Compared to Drug1 / Nonrandomized,
Control Active,
Cross-Over,
Open Label,
Pharmacokinetic/
Bio-Availability/
Food Effect,
Diagnostic / COMPLETED / 2001-06-01 / ANALYSIS
LEGACY / COSTART
(Adverse Events)
5th Ed.
SDSP-001-03 / PK In Vivo EtOH Interaction in Healthy Subjects / Nonrandomized,
Control Active,
ParallelAssigment,
Open Label,
Pharmacokinetic,
Pharmacodynamic,
Basic Science / COMPLETED / 2010-09-01 / ANALYSIS
LEGACY / MedDRA
(Adverse Events)
12.0
MedDRA
(Medical History)
11.0
WHO-DD
(Medications)
2009Mar01
Phase 1 Interventional Studies - Asthma
SDSP-001-04 / A Safety, Tolerability and Efficacy Study in Subjects with Asthma / Nonrandomized,
Control None,
Parallel Assignment,
Open Label,
Pharmacokinetic/
Pharmacodynamic/
Tolerability,
Treatment / COMPLETED / 2011-09-01 / ANALYSIS
LEGACY / MedDRA
(Adverse Events)
14.0
WHO-DD
(Medications)
2011Mar01
SDSP-001-05 / Study in Asthma Patients Evaluating the Effect of Doses of SDSP-001 on the Amount, if Any, of Cortisol Produced by the Adrenal Glands / Nonrandomized,
Control None,
Single Group,
Open Label,
Pharmacokinetic,
Basic Science / COMPLETED / 2011-12-01 / SDTM v1.1/
SDTM IG 3.1.1
Up-version
TBD
SDTM v1.2 /
SDTMIG 3.1.2
SDTM
define.xml 2.0 / MedDRA
(Adverse Events)
14.1
WHO-DD
(Medications)
2011Mar01
Phase 2 Interventional Studies - Asthma
SDSP-001-06 / Study of SPSP-001 vs Placebo in Moderate to Severe Asthma / Randomized,
Control Placebo,
Cross-Over,
Double Blind,
Safety/Efficacy,
Treatment / ONGOING / 2010-03-15 / SDTM v1.2/
SDTM IG 3.1.2
Amendment 1
SDTM
define.xml 1.0
ADaM v2.1/
ADaM IG1.0
ADaM
define.xml 1.0 / CDISC SDTM Terminology
2009-07-06
MedDRA
(Adverse Events)
13.0
WHO-DD
(Medications)
March 2010
Phase 2 Interventional Studies – COPD
SDSP-001-09 / Adjunctive Trial of SPSP-001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) / Randomized,
Control Active,
Parallel Assignment,
Double Blind,
Safety/Efficacy,
Treatment / ONGOING / 2015-03-15 / SDTM v1.2 /
SDTMIG 3.1.2
SDTM
define.xml 1.0
ADaM v2.1/
ADaM IG1.0
ADaM
define.xml 2.0
Up-versioned
2016-06-09
SDTM v1.3 /
SDTMIG 3.1.3
SDTM
define.xml 2.0 / CDISC SDTM
Terminology
2015-03-27
MedDRA
(Adverse Events)
17.0
WHO-DD
(Medications)
March 2014
Up-versioned
2016-06-09
MedDRA
(Adverse Events)
18.1
Phase 3 Interventional Studies - Asthma
SDSP-001-07 / A Proof-of-Concept Trial in Patients with Severe, Difficult to Control, Non-atopic Asthma / Nonrandomized,
Control None,
Single Group,
Open Label,
Safety/Efficacy,
Treatment / PLANNED / Q1 2016
<forecasted FPV> / SDTM v1.4 /
SDTM IG 3.2
SDTM
define.xml 2.0
ADaM v2.1 /
ADaM IG1.0
ADAM
define.xml 2.0 / CDISC SDTM Terminology
2015-06-26
MedDRA
(Adverse Events)
18.0
WHO-DD
(Medications)
March 2015
SDSP-001-08 / AStudyof SDSP-001 in Adolescent Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication / Randomized,
Control Active,
Cross-Over,
Single Blind,
Safety/Efficacy,
Treatment / PLANNED / Q2 2016
<forecasted FPV> / SDTM v1.4 /
SDTM IG3.2
SDTM
define.xml 2.0
ADaM v2.1 /
ADaM IG 1.0
ADaM
define.xml 2.0 / CDISC SDTM Terminology
2015-06-26
MedDRA
(Adverse Events)
18.1
WHO-DD
(Medications)
March 2016

4.3 Integrated Studies

Data Pool Identifier / Data Pool
(List of Studies) / Pool
Status / Pool Description / Exchange
Standards / Terminology Standards
ISS-Asthma / SDSP-001-06
SDSP-001-07
SDSP-001-08
SDSP-001-09 / CURRENT / ISS for Asthma Q3 2016 / SDTM v1.2/
SDTM IG 3.2.1
Amendment 1
ADaM v2.1 /
ADaM IG 1.0
ADaM
define.xml2.0 / CDISC SDTM Terminology
2015-06-26
MedDRA
(AdverseEvents)
18.1
WHO-DD
(Medications)
March 2015
ISE-Asthma / SDSP-001-07
SDSP-001-08 / PLANNED / ISE for Asthma Q2 2017 / ADaM v2.1 /
ADaM IG 1.0
ADaM
define.xml2.0 / CDISC SDTM Terminology
2015-06-26
MedDRA
(Adverse Events)
18.1
WHO-DD
(Medications)
March 2015

5.Non-Conformance to Supported Standards Justification

Study Identifier / Expected Standard / Provided Standard / Justification for Non-Conformance to Standards
(including Exception Information)
SDSP-001-05 / SDTM v1.2 /
SDTM IG3.1.2 / SDTM v1.1/
SDTM IG 3.1.1 / Study completed 2013-02-09 when provided standard was acceptable. Waiver not permitted by FDA.
SDSP-001-06 / SDTM v1.3 /
SDTM IG3.1.3 / SDTM v1.2/
SDTM IG 3.1.2 Amendment 1 / SDTM –

• Additional domains CE, IS, and PR from 1.4 are included

SDSP-001-09 / SDTM v1.3 /
SDTM IG3.1.3 / COPD Domains / SDTM & ADaM – Study uses COPD standards

6.FDA Data Standards Discussions

Date of Discussion / Meeting Identifier / Form of Discussion / Result/Agreement
2013-04-09 / 32-444-2913 / Teleconference / FDA did not agree with the SDTM standards for study SDSP-001-05. The data will be up-versioned to SDTM 1.4/SDTM IG 3.2.

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7.References

1StudyDataTechnicalConformanceGuide[

2Data Standards Catalog

[

3ComparisonChartofFDA,EnvironmentalProtectionAgency(EPA),OrganizationforEconomicCo-operationandDevelopment(OECD)

[

4US Public Law 110-85, Title VIII, Section 801

[

5CDISCSENDControlledTerminology

[

6CDISCSDTMControlledTerminology

[

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