Meeting 130523 - Overview of SDTMIG 3.1.4 - Barrie Nelson

© CDISC 2012

SDTMIG v3.1.4

Presenter: Barrie Nelson (SDS Leadership Team)

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© CDISC 2012

Agenda

• SDTMIG Contents

• SDTMIG for Associated Persons

• SDTM v1.4

• SDTMIG publication format

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© CDISC 2012

SDTMIG 3.1.4

Domain Additions:• DD – Death Details

• HO – Hospitalizations (Batch 3 Public Review)

• IS & SR – Immunogenicity Spec Assess + Skin Response

• MI – Microscopic Findings

• MO – Morphology

• PR – Procedures

• RP – Reproductive System Findings

• SS – Subject Status

• TD – Trial Disease Assessment

© CDISC 2012

SDTMIG 3.1.4 [contd.]

Continuing Discussion:

• EX/EC – Exposure domains

New Implementation Guide:

SDTMIG for Associated Persons (Batch 3 Public Review)

Updated SDTM:

SDTM v1.4 (Batch 3 Public Review)

© CDISC 2012

Death Details (DD)

• Supplemental data that are typically collected when a death occurs, such as the official cause of death, secondary cause of death, location of death

• Does not replace existing data such as the SAE details in AE

• Does not introduce a new requirement to collect information that is not already indicated as Good Clinical Practice or defined in regulatory guidelines

• It provides a consistent dataset for the submission of information that previously did not have a clearly defined home

Note: several domains may hold death-related information. This document gives an example of how these domains can be linked together using RELREC. This provides the means to assemble the data from different domains to present a complete overview of the death.

© CDISC 2012

Immunogenicity (IS & SR)

• The Immunogenicity Specimen Assessments (IS) Findings domain and Skin Response (SR) Findings About domain are used for tests that determine whether a substance provoked/caused/induced an immune response and for recording injection site reactions. For example:

A vaccine induces an immune response that is desired.

Alternatively, a cellular therapy induces an immune response that is not desired.

This domain will contain lab results

• The SR domain data will represent dermal response to antigen data.

Usually data obtained from skin prick tests

© CDISC 2012

Microscopic Findings (MI)

• Captures all Microscopic Findings information related to the

subject in a Findings domain.

• Reflects details of histopathologic examinations which are

the microscopic study of characteristic tissue abnormalities

by employing various histochemical and

immunohistochemical stains.

For example, histologic type, histologic grade, stage,

diagnosis, and slide stain results from

pathology/histopathology examination are MI findings

© CDISC 2012

Morphology (MO)

• Macroscopic results that are seen by the naked eye or

observed via procedures such as imaging modalities,

endoscopy, or other technologies

Examples: size, shape, color, and abnormalities of body parts

or specimens.

• Information about the procedure may or may not be

collected. If collected, a corresponding PR domain may be

created with appropriate linkage variables and the use of

RELREC

• The Morphology domain is used for all macroscopic findings

in human clinical trials.

© CDISC 2012

Procedures (PR)

• PR represents collected data that describes a subject‟s

therapeutic and diagnostic procedures, such as:

disease screening (e.g., mammogram, pap smear)

endoscopic examinations (e.g., arthroscopy, colonoscopy)

diagnostic tests (e.g., amniocentesis, biopsy)

therapeutic procedures (e.g., ablation therapy, catheterization)

surgical procedures (e.g., curative surgery)

• Measurements obtained from procedures are to be

represented in their respective Findings domain(s).

© CDISC 2012

Reproductive System Findings (RS)

• Findings related the reproduction system will be represented

in the RS domain.

• Data typically included in the RS would include:

Child bearing potential

Menopause date, Menopause status

Birth Control Method

Pregnancy information

• Birth control methods might previously have been

represented in the Subject Characteristics domain (SC) this

should now be included in RS

• Medications associated with reproductive health shall be

represented in the Concomitant Medications (CM) domain

© CDISC 2012

Subject Status (SS)

• Subject Status is for data relating to general subject

characteristics which are evaluated periodically to determine

if they have changed.

For example: repeated survival questions where mortality is

assessed many times during an ongoing study follow-up

period.

• Subject Status does not contain details about the

circumstances of a subject‟s status.

The response to the status assessment may trigger collection

of additional details, but those details are to be stored in

appropriate separate domains.

© CDISC 2012

Trial Disease Assessment (TD)

• An addition to the trial design model. Disease assessments

will occur on a fixed schedule (limited to Oncology)

• The TD domain provides information on the protocol-

specified disease assessment schedule, used for

comparison of planned and actual efficacy assessments in

order to determine compliance with the schedule.

In oncology studies, good compliance with the disease-

assessment schedule is essential to reduce the risk of

„assessment time bias‟.

The TD domain makes possible an evaluation of „assessment

time bias‟ from SDTM

TD has limited utility within oncology and was developed

specifically with RECIST in mind and where an assessment

time bias analysis is appropriate.

It is understood that extending this approach to Cheson and

other criteria may not be appropriate or may pose difficulties.

© CDISC 2012

Exposure Domains (EX / EC)

• The updates to the EX SDTM and a new proposed EC

domain are still under discussion.

• Exposure data has a lot of complexity

• The EX updates attempt to address the following:

Planned versus Actual dosing

Provide information when a dose wasn‟t given

Provide details of device used for administration

Provide details of who recorded the dosing information

• The Exposure as Collected (EC) domain enables data

to be represented in the format that it was collected.

The collected format may differ from the actual dose that will

be represented in EX

© CDISC 2012

• Associated Persons (AP) are persons who can be

associated with a study, a particular study subject or a

device used in the study.

• AP may or may not have a familial relationship to a study

subject. AP domains are created using SDTM variables, with

the application of specific AP rules, including:

AP domains will follow the AP assumptions for the Identifier variables.

AP will be the prefix for the domain and dataset name, and will identify

the dataset as AP data.

APID will be required in all AP datasets, and will identify records in a

data warehouse as AP data.

• The SDTMIG for AP provides implementation rules and

advice. Unless an exception is described, all other general

assumptions about SDTM and SDTMIG variables and

domains will apply to AP data.

SDTMIG for Associated Persons

© CDISC 2012

SDTMIG for AP - Example

1.1.1.1 EXAMPLES FOR ASSOCIATED PERSONS MEDICAL HISTORY DOMAIN MODEL

Example 1

In this example, a study subject with the unique identifier of “2011 -02-02-031” has family members who have been diagnosed with

Pompe Disease. The CRF below has collected data about both single-person APs and multiple-person APs.

Family Pompe Disease Hi story

Have any of the following biological relatives been diagnosed with Pompe Disease?

Mother: Yes No

Father: Yes No

Sibling(s): Yes No If yes, how many? _____

Cousin(s): Yes No If yes, how many? _____

Rows 1-2: The parents of the subject.

Row 3: The sibling(s) of the subject. Since no siblings have been diagnosed with Pompe Disease, their number has not been

recorded.

Row 4: The cousin(s) of the subject. Since at least one cousin has been diagnosed with Pompe Disease, there is a supplemental

qualifiers dataset to record how many.

apmh.xpt Row STUDYID DOMAIN APID MHSEQ RSUBJID SREL MHTERM MHPRESP MHOCCUR

1 2011-02-

02 APMH

2011-02-02-

N120 1

2011-02-02-

031

MOTHER,

BIOLOGICAL

POMPE

DISEASE Y N

2 2011-02-

02 APMH

2011-02-02-

N121 1

2011-02-02-

031

FATHER,

BIOLOGICAL

POMPE

DISEASE Y Y

3 2011-02-

02 APMH

2011-02-02-

NS122 1

2011-02-02-

031 SIBLING, FULL

POMPE

DISEASE Y N

4 2011-02-

02 APMH

2011-02-02-

NS123 1

2011-02-02-

031

COUSIN,

BIOLOGICAL

POMPE

DISEASE Y Y

sqapmh.xpt Row STUDYID RDOMAIN APID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL

1 2011-02-02 APMH 2011-02-02-NS123 MHSEQ 1 NUMDX Number Diagnosed 2 CRF

© CDISC 2012

The following new sections have been added:

• Section 3.5 - The Trial Disease Assessments

• Section 5 - Applying Model Fundamentals to Associated

Persons

The following sections have been re-numbered within SDTM

V1.4:

• Section 6 “Using the Model for Regulatory Submissions” - was

previously “Section 5” in SDTM V1.3

• Section 7 “SDTM Version History” - was previously “Section 6”

in SDTM V1.3

SDTM v1.4 – What’s new?

© CDISC 2012

The following new tables have been included in Version 1.4:

• Table 3.5.1 - Trial Disease Assessments

• Table 5.1.1 - Associated Persons Data – Identifier Variables

• Table 5.2.1 - APRELSUB Table

New variables have been added to the following sections:

• Table 2.2.1 - Interventions

• Table 2.2.2 - Events

• Table 2.2.3 - Findings

• Table 2.2.4 - Identifiers

• Table 2.2.5 - Timing Variables

SDTM v1.4 – What’s new? [contd.]

© CDISC 2012

CHANGES FROM SDTM V1.3 TO SDTM V1.4

Additions

Table 2.2.1 - Interventions:

• --MODE Mode

• --DOSTKN Number of Doses Taken

• --LAT Laterality

• --DIR Directionality

• --PORTOT Portion or Totality

• --FAST Fasting Status

• --PSTRG Pharmaceutical Strength

• --PSTRG Pharmaceutical Strength Unit

• --ADMDEV Method of Administration

• --MTHCOL Method of the Observation


© CDISC 2012


Additions

• Table 2.2.2 - Events:

• --LAT Laterality

• --DIR Directionality

• --PORTOT Portion or Totality

• --PARTY Accountable Party

• --PRTYID Identification of Accountable Party

• --ACNDEV Action Taken with Device


© CDISC 2012


Additions

Table 2.2.3 - Findings;

• --TSTDTL Measurement, Test or Examination Detail

• --RFRESV Reference Result Value

• --RFRESX Reference Result Source

• --RUNID Run ID

• --ANMETH Analysis Method

Table 2.2.4 - Identifiers;

• SPDEVID Sponsor Device Identifier


© CDISC 2012


Additions

Table 2.2.5 - Timing Variables;

• --EVINTX Evaluation Interval Text

• --STINT Planned Start of Evaluation Interval

• --ENINT Planned End of Evaluation Interval

Table 3.2.4 - Trial Disease Assessments:

• New Table, includes new variables: TDORDER,

TDANCVAR, TDSTOFF, TDTGTPAI, TDMINPAI,

TDMAXPAI, TDNUMRPT


© CDISC 2012


Additions

Table 5.1.1 – Associated Persons – Identifier variables:

• APID Associated Persons Identifier

• RSUBJID Related Subject

• RDEVID Related Device

• SREL Subject, Device, or Study Relationship

VARIABLES TO BE DEPRECATED (post SDTM V1.4)

Table 2.2.5 – Timing variable for all classes:

• --STRF: The functionality of this variable can be replaced by

the use of --STRTPT with --STTPT = RFSTDTC.

• --ENRF: The functionality of this variable can be replaced by

the use of --ENRTPT with --ENTPT = RFENDTC.


© CDISC 2012

• The SDTMIG publication will be organized differently

• All content from the V3.1.3 annotations will be incorporated

in the document itself

• The document will be split into sections, each section as a

distinct pdf doc

• Domain specifications will have a simplified numbering

system

• The full Implementation Guide will be published as a pdf

portfolio

• You will be able to simply print the portfolio in it‟s entirety or

print individual books in the portfolio

• TOCs will be developed for each section

SDTMIG v3.1.4 Publication Format

© CDISC 2012

• Sections 1-4

• Section 5 – Special Purpose

• Section 6 - Interventions

• Section 6 - Events

• Section 6 - Findings

• Section 7 - Trial Design

• Section 8 - Relationships

• Appendices

SDTMIG v3.1.4 Section Organization

© CDISC 2012

And right around the corner…

Batch 3:• SDTM – Study Data Tabulation Model v1.4

• AP UG – Associated Persons UG

• HO – Hospitalizations

SDTM v1.4, SDTMIG v3.1.4, SDTMIG-AP• Final Publication Estimate Q3 2013

Volunteers are always encouraged to join the SDS team and bring their Subject Matter Expertise to table to help out with development and early review cycles of new and updated SDTM specifications.

Look out for the upcoming Volunteer Webinar

Meeting 130523 - Overview of SDTMIG 3.1.4 - Barrie Nelson

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