SDSP, Inc. SDSP-002 Oncology 99998 SDSP
Study Data Standardization Plan
SDSP, Inc.
SDSP-002
Oncology
99998
Version 2017-01-01
Example Purpose:
The purpose of this document is to provide an example for industry of an SDSP document for an Oncology drug program entering into Phase 3 with 2 safety and efficacy studies, two phase 2 ongoing studies, and several legacy PK studies. This compound has 2 submissions planned.
Date / Updated Section(s) / Description of Changes2017-01-15 / New Document
2017-01-17 / 4.2 / Additional study SDSP-002-16
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 / TranslationADaM / 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 / DefinitionNonclinical / 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-002Indication / Oncology
IND / 99998
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-002 is a small molecule currently under clinical development for the treatment of different types of Oncology. It may be given intravenously or orally and is dosed alone or in a regimen with other drugs.
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SDSP, Inc. SDSP-002 Oncology 99998 SDSP
4.List of Studies and Standards
4.1Nonclinical
Study Identifier / Brief Title / StudyType / StudyStatus / StudyStartDate / ExchangeStandards / TerminologyStandards
Tox-14-1225 / FDG uptake in ABC-De11 xenografts treated with SDSP-002 IV weekly in rats / REPEAT DOSE TOXICITY / COMPLETED / 2007-03-04 / No Electronic Data / LEGACY
Tox-14-1226 / Antitumor Activity With SDSP-002 and Otherdrug as Single Agents Or Combined in Female Nude Mice Bearing FG9 Xenografts / CARDIOVASCULAR PHARMACOLOGY / COMPLETED / 2007-06-07 / No Electronic Data / LEGACY
Tox-14-1227 / Tolerability of 0.5mg/kg Daily Oral Dose of SDSP-002 in a Female Nude Rat / REPEAT DOSE TOXICITY / COMPLETED / 2007-09-10 / LEGACY / LEGACY
Tox-14-1228 / PK/PD Profile of SDSP-002 in ABC123 Tumor Bearing Mice / PRIMARY PHARMACODYNAMICS / COMPLETED / 2007-12-13 / LEGACY
tumor.xpt / LEGACY
Tox-15-1234 / A Single-dose Oral Toxicity Study of SDSP-002 in Rats / SINGLE DOSE TOXICITY / COMPLETED / 2014-04-05 / SDTM v1.2/
SEND IG 3.0
define.xml 1.0 / CDISC SEND Terminology 2013-12-20
Tox-15-1235 / A Single-dose Oral Toxicity Study of SDSP-002 in Dogs / FERTILITY AND EARLY EMBRYONIC DEVELOPMENT / COMPLETED / 2014-07-08 / SDTM v 1.2/
SEND IG 3.0
define.xml 1.0 / CDISC SEND Terminology 2013-12-20
Tox-15-1436 / A Four-week Oral Toxicity Study with SDSP-002 in Rats Followed by a Four-week Recovery Period / REPEAT DOSE TOXICITY / COMPLETED / 2015-10-11 / SDTM v1.2/
SEND IG 3.0
define.xml 1.0 / CDISC SEND Terminology 2015-03-27
TBD / Efficacy of SDSP-002 in Syngeneic Mouse with Lymphoma / CARCINOGENICITY / PLANNED / 2016-06
<forecasted Protocol sign> / SDTM v1.2/
SEND IG 3.0
tumor.xpt
define.xml 1.0 / CDISC SEND Terminology 2015-12-18
4.2Clinical
Study Identifier / Brief Title / StudyDesign / StudyStatus / Study StartDate / ExchangeStandards / TerminologyStandards
Phase 1Interventional Studies - Advanced Solid Tumors
SDSP-002-01 / Maximum Tolerated Dose of SDSP-002 Administered Intravenously in Patients with Advanced Solid Tumors / Nonrandomized,
Control None,
Single Group,
Open Label,
Safety,
Treatment / COMPLETED / 2008-03-01 / TABULATIONS
LEGACY
ANALYSIS LEGACY / MedDRA
(Adverse Events)
10.0
WHO-DD
(Medications)
2007-03
Phase 1 Interventional Studies - Advanced Hematological Malignancies
SDSP-002-02 / SDSP-002 Administered Intravenously in Patients with Advanced Hematological Malignancies / Randomized,
Control None,
Parallel Assignment,
Single Blind,
Pharmacokinetic,
Treatment / COMPLETED / 2008-06-01 / TABULATIONS
LEGACY
ANALYSIS LEGACY / MedDRA
(Adverse Events)
10.0
WHO-DD
(Medications)
2007-03
Phase 1 Interventional Studies - Advanced Non-hematological Malignancies
SDSP-002-09 / SDSP-002 Orally Administered Drug-drug Interaction with Ketoconazole in Patients with Advanced Non-hematologic Malignancies / Randomized,
Control None,
Cross-Over,
Double Blind, Pharmacokinetic/
Pharmacodynamic,
Diagnostic / COMPLETED / 2010-07-09 / SDTM v1.1 /
SDTM IG 3.1.1
SDTM
define.xml 1.0
ADaM v2.1 /
ADaM IG 1.0
ADaM
define.xml 1.0
Up-versioned
2015-06-09
SDTM v1.2/
SDTM IG 3.1.2 / CDISC SDTM Terminology
2007-06-05
MedDRA
(Adverse Events)
12.1
WHO-DD
(Medications)
2009-03
Up-versioned
2015-06-09
MedDRA
(Adverse Events)
18.0
SDSP-002-11 / Mass balance, Pharmacokinetics and Metabolism of SDSP-002 administered orally in patients with Advanced Non-hematologic Malignancies / Nonrandomized,
Control None,
Single Group,
Open Label,
Safety/Efficacy/
Pharmacokinetic,
Basic Science / COMPLETED / 2012-09-24 / SDTM v1.2 /
SDTM IG 3.1.2
SDTM
define.xml 1.0
ADaM v2.1 /
ADaM IG 1.0
ADaM
define.xml 1.0 / CDISC SDTM Terminology
2012-03-23
MedDRA
(Adverse Events)
15.0
MedDRA
(Medical History)
15.0
WHO-DD
(Medications)
2012-03
Phase 1 Interventional Studies - Advanced Solid Tumors or Relapsed/Refractory Lymphoma
SDSP-002-19 / SDSP-002 in patients with Advanced Solid Tumors or Relapsed/Refractory Lymphoma with Varying Degrees of Hepatic Function / Randomized,
Control None,
Parallel,
Double Blind,
Safety/Tolerability/
Pharmacokinetic/
Pharmacodynamic,
Treatment / ONGOING / 2014-04-21 / SDTM v1.3 /
SDTM IG 3.1.3
SDTM
define.xml 1.0
ADaM v2.1 /
ADaM IG 1.0
ADaM
define.xml 1.0 / CDISC SDTM Terminology
2013-10-04
MedDRA
(Adverse Events)
16.0
WHO-DD
(Medications)
2013-03
Phase 1/2 Interventional Studies –Relapsed or Refractory Multiple Myeloma
SDSP-002-03 / SDSP-002 Administered Intravenously in Patients with Relapsed or Refractory Multiple Myeloma / Nonrandomized,
Control None,
Single Group,
Open Label
Safety/Efficacy,
Treatment / COMPLETED / 2008-10-01 / TABULATIONS
LEGACY
ANALYSIS LEGACY / MedDRA
(Adverse Events)
10.1
WHO-DD
(Medications)
2008-03
Phase 1/2 Interventional Studies –Relapsed/Refractory Amyloidosis
SDSP-002-07 / SDSP-002 Administered Orally, Weekly in Patients with Relapsed/Refractory Amyloidosis / Randomized,
Control Active,
Parallel Assignment,
Single Blind,
Safety/Efficacy,
Treatment / COMPLETED / 2010-09-01 / SDTM v1.2 /
SDTM IG 3.1.2
SDTM
define.xml 1.0
ADaM v1.1 /
ADaM IG NA
ADaM
define.xml 1.0 / CDISC SDTM Terminology
2010-03-05
MedDRA
(Adverse Events)
12.1
WHO-DD
(Medications)
2010-03
Phase 1/2 Interventional Studies –Relapsed or Refractory Peripheral T-Cell Lymphoma
SDSP-002-08 / Safety, PK and Dose Escalation of SDSP-002 Administered Orally with CHOP in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma / Nonrandomized,
Control Active,
Parallel Assigment,
Open Label,
Safety/Pharmacokinetic/
Tolerability,
Treatment / COMPLETED / 2011-12-01 / SDTM v1.2 /
SDTM IG 3.1.2
SDTM
define.xml 1.0
ADaM v2.1 /
ADaM IG 1.0
ADaM
define.xml 1.0 / CDISC SDTM Terminology
2011-04-08
MedDRA
(Adverse Events)
14.0
WHO-DD
(Medications)
2011-03
SDSP-002-04 / SDSP-002 Administered Orally in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma / Randomized,
Control Active,
Parallel Assignment,
Double Blind,
Safety/Efficacy/
Pharmacokinetic/
Pharmacodynamic,
Treatment / COMPLETED / 2009-02-03 / ANALYSIS LEGACY
SDTM v1.1 /
SDTM IG 3.1.1
SDTM
define.xml 1.0 / MedDRA
(Adverse Events)
11.1
WHO-DD
(Medications)
2008-03
Phase 2 Interventional Studies –Acute Myelogenous Leukemia
SDSP-002-05 / SDSP-002 Administered Orally in Patients with Acute Myelogenous Leukemia / Nonrandomized,
Control Active,
Parallel,
Double Blind,
Safety/Efficacy/
Pharmacokinetic/
Pharmacodynamic,
Treatment / COMPLETED / 2009-02-10 / SDTM v1.1 /
SDTM IG 3.1.1
SDTM
define.xml 1.0
ANALYSIS LEGACY / MedDRA
(Adverse Events)
11.1
WHO-DD
(Medications)
2008-03
Phase 2 Interventional Studies –Relapsed or Refractory Ovarian or Breast Cancer
SDSP-002-06 / SDSP-002 in Patients with Relapsed or Refractory Ovarian or Breast Cancer / Nonrandomized,
Control Active,
Parallel Assignment,
Open Label,
Safety/Efficacy/
Pharmacokinetic/
Pharmacodynamic,
Treatment / COMPLETED / 2009-03-25 / SDTM v1.2 /
SDTM IG 3.1.2
Amendment 1
SDTM
define.xml 1.0
ADaM v1.1 /
ADaM IG NA
ADaM
define.xml 1.0 / MedDRA
(Adverse Events)
11.1
WHO-DD
(Medications)
2008-03
Phase 2 Interventional Studies –Patients Previously Enrolled in SDSP-002 Studies
SDSP-002-16 / Open-Label Rollover Protocol for Patients Previously Enrolled in SDSP-002 Studies / Nonrandomized,
Control None,
Single Group,
Open Label,
Safety,
Treatment / PLANNED / 2016-10
<forecasted FPV> / SDTM v1.2 /
SDTM IG 3.1.2
Amendment 1
SDTM
define.xml 2.0
ADaM v2.1 /
ADaM IG 1.0
ADaM
define.xml 2.0
Up-version
TBD
SDTM v1.3/
SDTM IG 3.1.3 / CDISC SDTM Terminology
TBD
MedDRA
(Adverse Events/
Medical History)
19.0
WHO-DD
(Medications)
2016-03
Phase 3 Interventional Studies –Relapsed or Refractory Peripheral T-Cell Lymphoma
SDSP-002-10 / SDSP-002 or Investigator’s Choice in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma / Nonrandomized,
Control Active,
Cross-Over,
Double Blind/Open Label,
Safety/Efficacy/
Pharmacokinetic/
Pharmacodynamic,
Treatment / ONGOING / 2012-04-12 / SDTM v1.2 /
SDTM IG 3.1.2
SDTM
define.xml 1.0
ADaM v2.1 /
ADaM IG 1.0
ADaM
define.xml 1.0
Up-version
TBD
SDTM v1.3/
SDTM IG 3.1.3
SDTM
define.xml 2.0 / CDISC SDTM Terminology
2011-07-22
MedDRA
(Adverse Events)
18.1
WHO-DD
(Medications)
2015-03
4.3 Integrated Studies
Data Pool Identifier / Data Pool(List of Studies) / Pool
Status / Pool Description / Exchange
Standards / Terminology Standards
ISS-RRPTCL / SDSP-002-03
SDSP-002-04
SDSP-002-05
SDSP-002-06
SDSP-002-07
SDSP-002-08
SDSP-002-09
SDSP-002-10 / CURRENT / ISS - Relapsed or Refractory Peripheral T-Cell Lymphoma - Interim Analysis 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)
2015-03
ISE-RRPTCL / SDSP-002-08
SDSP-002-10 / PLANNED / ISE - Relapsed or Refractory Peripheral T-Cell Lymphoma - Interim Analysis 1 / 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)
2015-03
ISS-RROVB / SDSP-002-03
SDSP-002-04
SDSP-002-05
SDSP-002-06
SDSP-002-07
SDSP-002-08
SDSP-002-09
SDSP-002-10
SDSP-002-19 / Planned / ISS – Relapsed or Refractory Ovarian or Breast Cancer - Interim Analysis 1 / ADaM v TBD /
ADaM IG TBD
ADaM
define.xml TBD / CDISC SDTM Terminology
TBD
MedDRA
(Adverse Events)
TBD
WHO-DD
(Medications)
TBD
ISE-RROVB / SDSP-002-06
SDSP-002-15 / Planned / ISE – Relapsed or Refractory Ovarian or Breast Cancer - Interim Analysis 1 / ADaM v TBD /
ADaM IG TBD
ADaM
define.xml TBD / CDISC SDTM Terminology
TBD
MedDRA
(Adverse Events)
TBD
WHO-DD
(Medications)
TBD
5.Non-Conformance to Supported Standards Justification
Study Identifier / Expected Standard / Provided Standard / Justification for Non-Conformance to Standards(including Exception Information)
SDSP-002-04
SDSP-002-05
SDSP-002-06 / SDTM v1.1 /
SDTM IG3.1.1
ADaM v1.1
define.xml 1.0 / SDTM v1.1 (like)
ADaMV1.1 (like)
define.pdf
Item 11 / SDTM datasets follow CDISC without supplemental qualifiers.
Some ADaM datasets have extra variables.
First Studies in CDISC
SDTM –
- Efficacy data is in the EF dataset which has a findings structure
- Cancer Medications prior to the study are in the PT sponsor defined custom dataset which has an intervention structure
- There are no trial design datasets for these studies
- Followed as much as possible. Somewhat limited as no IG released.
- No define.xml as define.pdf was defined.
SDSP-002-10 / SDTM v1.2 /
SDTM IG3.1.2
ADaM v2.1 /
ADaM IG 1.0 / Oncology Domains (draft)
ADAE / SDTM – Study uses draft Oncology domains (TU, TR, RS)
ADaM – Study uses ADAE the new ADaM occurrence model.
SDSP-002-15
SDSP-002-20 / SDTM v1.3 /
SDTM IG3.2
ADaM v2.1 /
ADaM IG 1.0 / Oncology Domains (draft)
ADAE / SDTM – Study uses draft Breast Cancer standards
ADaM – Study uses a BDS version of ADAE in addition to ADAE.
6.FDA Data Standards Discussions
Date of Discussion / Meeting Identifier / Form of Discussion / Result/Agreement2014-09-14 / 32-368-5942 / Teleconference / FDA agreed Legacy Phase I studies can be submitted using Item 11 data with define.pdf with conversion to SDTM or ADaM.
FDA agreed that studies in SDTM 1.1/ SDTM IG 3.1.1 can remain in this version for submission. Studies include: SDSP-002-004, SDSP-002-05, SDSP-002-05.
2015-03-03 / 32-659-4884 / Type C Meeting / FDA agreed draft Oncology domains used in SDSP-002-10 can be submitted.
FDA agreed that draft Breast Cancer Standards can be used in SDSP-002-15 & SDSP-002-20
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SDSP, Inc. SDSP-002 Oncology 99998 SDSP
7.References
1StudyDataTechnicalConformanceGuide[
2Data Standards Catalog
[
3ComparisonChartofFDA,EnvironmentalProtectionAgency(EPA),OrganizationforEconomicCo-operationandDevelopment(OECD)
[
4US Public Law 110-85, Title VIII, Section 801
[
5CDISCSENDControlledTerminology
[
6CDISCSDTMControlledTerminology
[
7clinicaltrials.gov Study Design Terminology
[
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