Download SDSP-001 - PhUSE Wiki

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.
SDSP, Inc. SDSP-001 Asthma 99999
SDSP
Compound SDSP Revision History
Date
Updated
Section(s)
2017-01-01
2017-01-15
Description of Changes
New Document
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
Page 2 of 15
SDSP, Inc. SDSP-001 Asthma 99999
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 .......................................................................................................................................... 9
4.3
Integrated Studies ........................................................................................................................ 13
5.
Non-Conformance to Supported Standards Justification .................................................................... 14
6.
FDA Data Standards Discussions ....................................................................................................... 14
7.
References........................................................................................................................................... 15
Page 3 of 15
SDSP, Inc. SDSP-001 Asthma 99999
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
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
Page 4 of 15
SDSP, Inc. SDSP-001 Asthma 99999
SDSP
1.4 Definitions
Term
Planned Study
Ongoing
Study
Completed
Study
Nonclinical
Study Start
Date
Clinical
Nonclinical
& Clinical
Pooled
Studies
Up-version
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.
Planned
Study data from more than one study will be pooled/integrated..
The version of the Exchange Standards and/or Technology Standards was transformed
for the study or pool.
Page 5 of 15
SDSP, Inc. SDSP-001 Asthma 99999
SDSP
2. General Sponsor Information
Name of Product
SDSP-001
Indication
Asthma
IND
99999
Sponsor Name
SDSP, Inc.
Sponsor Contact
First Lastname
Sponsor Contact Email
[email protected]
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.
Page 6 of 15
SDSP, Inc. SDSP-001 Asthma 99999
SDSP
4. List of Studies and Standards
4.1 Nonclinical
Study
Study Type
Identifier Brief Title
Tox-1221 Effects on
REPEAT DOSE TOXICITY
Cardiovascular System
in Conscious Dogs with
subcutaneous dosing of
Compound X
Tox-1234 Modified Irwin test and
TOXICOKINETICS
effect on body
temperature following
single oral
administration in the rat
Tox-1235 A single-dose toxicity
SINGLE DOSE TOXICITY
oral toxicity study of
Compound X in Dogs
Tox-1437 A four-week oral
PHARMACOKINETIC DRUG
INTERACTIONS
toxicity study with
compound X in rats
followed by a fourweek recovery period
A thirteen-week oral
REPEAT DOSE TOXICITY
Tox-1489
toxicity study with
compound X in rats
followed by an eightweek recovery period
Study Status
COMPLETED
Study Start
Date
1992-12-01
Exchange
Standards
No Electronic Data
Terminology
Standards
NONE
COMPLETED
1993-02-09
No Electronic Data
NONE
COMPLETED
1995-02-02
LEGACY
Sponsor Defined
Terminology
define.xml 1.0
COMPLETED
1999-03-20
LEGACY
Sponsor Defined
Terminology
define.xml 1.0
COMPLETED
2006-05-28
LEGACY
Sponsor Defined
Terminology
define.xml 1.0
Page 7 of 15
SDSP, Inc. SDSP-001 Asthma 99999
Study
Study Type
Identifier Brief Title
Tox-1490 A thirteen-week oral
REPEAT DOSE TOXICITY
toxicity study with
compound X in dogs
followed by an eightweek recovery period
Tox-1577 A six-month oral
REPEAT DOSE TOXICITY
toxicity study with
compound X in rats
followed by a twomonth recovery period
Tox-1578 A nine-month oral
ANALYTICAL METHODS AND
VALIDATION REPORTS
toxicity study with
compound X in dogs
followed by a threemonth recovery period
TBD
A two-year dietary
admix carcinogenicity
study in mice with
Compound X
CARCINOGENICITY
SDSP
Study Status
COMPLETED
Study Start
Date
2009-06-21
Exchange
Standards
SDTM V1.2/
SEND IG 3.0
Terminology
Standards
Sponsor Defined
Terminology
define.xml 1.0
COMPLETED
2011-11-23
SDTM V1.2/
SEND IG 3.0
CDISC SEND
Terminology
2011-06-05
define.xml 1.0
COMPLETED
2011-12-01
SDTM v1.2/
SEND IG 3.0
CDISC SEND
Terminology
2011-07-22
ts.xpt
PLANNED
2Q 2016
<forecasted
Protocol sign>
define.xml 1.0
TBD
TBD
Page 8 of 15
SDSP, Inc. SDSP-001 Asthma 99999
SDSP
4.2 Clinical
Study
Identifier Brief Title
SDSP-001- Food Effect in Healthy
01
Subjects
ABC-
Study Start
Study Design
Study Status
Date
Phase 1 Interventional Studies - Healthy Subjects
Nonrandomized,
COMPLETED
2001-03-01
Control None,
Single Group,
Open Label,
Pharmacokinetic,
Basic Science
Exchange
Standards
Terminology
Standards
ANALYSIS
LEGACY
COSTART
(Adverse Events)
5th Ed.
SDSP-001- Food Bioavailability in
02
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- PK In Vivo EtOH
03
Interaction in Healthy
Subjects
Nonrandomized,
Control Active,
Parallel Assigment,
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
Page 9 of 15
SDSP, Inc. SDSP-001 Asthma 99999
Study
Identifier Brief Title
SDSP-001- A Safety, Tolerability and
04
Efficacy Study in Subjects
with Asthma
SDSP-001- Study in Asthma Patients
05
Evaluating the Effect of
Doses of SDSP-001 on the
Amount, if Any, of
Cortisol Produced by the
Adrenal Glands
SDSP
Study Start
Study Design
Study Status
Date
Phase 1 Interventional Studies - Asthma
Nonrandomized,
2011-09-01
COMPLETED
Control None,
Parallel Assignment,
Open Label,
Pharmacokinetic/
Pharmacodynamic/
Tolerability,
Treatment
Nonrandomized,
Control None,
Single Group,
Open Label,
Pharmacokinetic,
Basic Science
COMPLETED
2011-12-01
Exchange
Standards
Terminology
Standards
ANALYSIS
LEGACY
MedDRA
(Adverse Events)
14.0
WHO-DD
(Medications)
2011Mar01
SDTM v1.1/
SDTM IG 3.1.1
Up-version
TBD
SDTM v1.2 /
SDTM IG 3.1.2
SDSP-001- Study of SPSP-001 vs
06
Placebo in Moderate to
Severe Asthma
Phase 2 Interventional Studies - Asthma
Randomized,
2010-03-15
ONGOING
Control Placebo,
Cross-Over,
Double Blind,
Safety/Efficacy,
Treatment
MedDRA
(Adverse Events)
14.1
WHO-DD
(Medications)
2011Mar01
SDTM
SDTM
v1.2/
define.xml
2.0
SDTM
IG 3.1.2
Amendment 1
CDISC SDTM
Terminology
2009-07-06
SDTM
define.xml 1.0
MedDRA
(Adverse Events)
13.0
ADaM v2.1/
ADaM IG 1.0
ADaM
define.xml 1.0
WHO-DD
(Medications)
March 2010
Page 10 of 15
SDSP, Inc. SDSP-001 Asthma 99999
Study
Identifier Brief Title
SDSP-001- Adjunctive Trial of SPSP09
001 for the Treatment of
Chronic Obstructive
Pulmonary Disease
(COPD)
Study Start
Study Design
Study Status
Date
Phase 2 Interventional Studies – COPD
Randomized,
2015-03-15
ONGOING
Control Active,
Parallel Assignment,
Double Blind,
Safety/Efficacy,
Treatment
SDSP
Exchange
Standards
Terminology
Standards
SDTM v1.2 /
SDTM IG 3.1.2
CDISC SDTM
Terminology
2015-03-27
SDTM
define.xml 1.0
ADaM v2.1/
ADaM IG 1.0
MedDRA
(Adverse Events)
17.0
ADaM
define.xml 2.0
WHO-DD
(Medications)
March 2014
Up-versioned
2016-06-09
Up-versioned
2016-06-09
SDTM v1.3 /
SDTM IG 3.1.3
MedDRA
(Adverse Events)
18.1
SDTM
define.xml 2.0
Page 11 of 15
SDSP, Inc. SDSP-001 Asthma 99999
Study
Identifier Brief Title
SDSP-001- A Proof-of-Concept Trial
07
in Patients with Severe,
Difficult to Control, Nonatopic Asthma
SDSP
Study Start
Study Design
Study Status
Date
Phase 3 Interventional Studies - Asthma
Nonrandomized,
PLANNED
Q1 2016
<forecasted FPV>
Control None,
Single Group,
Open Label,
Safety/Efficacy,
Treatment
Exchange
Standards
Terminology
Standards
SDTM v1.4 /
SDTM IG 3.2
CDISC SDTM
Terminology
2015-06-26
SDTM
define.xml 2.0
ADaM v2.1 /
ADaM IG1.0
ADAM
define.xml 2.0
SDSP-001- A Study of SDSP-001 in
08
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 IG 3.2
SDTM
define.xml 2.0
ADaM v2.1 /
ADaM IG 1.0
ADaM
define.xml 2.0
MedDRA
(Adverse Events)
18.0
WHO-DD
(Medications)
March 2015
CDISC SDTM
Terminology
2015-06-26
MedDRA
(Adverse Events)
18.1
WHO-DD
(Medications)
March 2016
Page 12 of 15
SDSP, Inc. SDSP-001 Asthma 99999
SDSP
4.3 Integrated Studies
Data Pool
Data Pool
Pool
Pool Description
Identifier (List of Studies)
Status
ISS-Asthma SDSP-001-06
CURRENT ISS for Asthma Q3 2016
SDSP-001-07
SDSP-001-08
SDSP-001-09
Exchange
Standards
SDTM v1.2/
SDTM IG 3.2.1
Amendment 1
Terminology
Standards
CDISC SDTM
Terminology
2015-06-26
ADaM v2.1 /
ADaM IG 1.0
MedDRA
(Adverse Events)
18.1
ADaM
define.xml 2.0
ISE-Asthma SDSP-001-07
SDSP-001-08
PLANNED ISE for Asthma Q2 2017
ADaM v2.1 /
ADaM IG 1.0
ADaM
define.xml 2.0
WHO-DD
(Medications)
March 2015
CDISC SDTM
Terminology
2015-06-26
MedDRA
(Adverse Events)
18.1
WHO-DD
(Medications)
March 2015
Page 13 of 15
SDSP, Inc. SDSP-001 Asthma 99999
SDSP
5. Non-Conformance to Supported Standards Justification
Study Identifier
Expected Standard
Provided Standard
Justification for Non-Conformance to Standards
(including Exception Information)
Study completed 2013-02-09 when provided standard was acceptable.
Waiver not permitted by FDA.
SDSP-001-05
SDTM v1.2 /
SDTM IG 3.1.2
SDTM v1.1/
SDTM IG 3.1.1
SDSP-001-06
SDTM v1.3 /
SDTM IG 3.1.3
SDTM v1.2/
SDTM IG 3.1.2
Amendment 1
SDTM –
SDTM v1.3 /
SDTM IG 3.1.3
COPD Domains
SDTM & ADaM – Study uses COPD standards
SDSP-001-09

Additional domains CE, IS, and PR from 1.4 are included
6. FDA Data Standards Discussions
Date of
Discussion
2013-04-09
Meeting
Identifier
32-444-2913
Form of Discussion
Teleconference
Result/Agreement
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.
Page 14 of 15
SDSP, Inc. SDSP-001 Asthma 99999
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]
Page 15 of 15