Associated Persons Domains - PharmaSUG · PharmaSUG SDE RTP 2016 October 27, 2016. Title: Slide 1...

Associated Persons Domains

Who, What, When, Where, Why, and How?

Michael Stackhouse

Alyssa Wittle

PharmaSUG SDE RTP 2016October 27, 2016

What and Why?

2 Proprietary & Confidential. © 2016 Chiltern

● SDTM Associated Persons Implementation Guide

• Standardized place for non-subject specific data

• This data is not about the study subject, so it has no home in a subject level SDTM

• Intended for human data

● Family Medical History

● Family Substance Abuse History

● Accidental Exposure (non-subject)

● AEs belonging to a non-subject due to

accidental exposure or device malfunction

When?

● Donor Information

● Caretakers

● Sexual Partner Information

● Persons in the Subject’s Environment


● When do Associated Persons domains apply to a study?

Who?


● For whom are these domains intended?

● Who is an Associated Person (AP)?

• The person can be associated with the subject or the study

• Data needs to be about the AP

Where?


● Where do I put all of the information?

• An AP domain can be created based on traditional SDTM domain

• Prefixes of “AP” are added to the SDTM domain name to identify them as Associated Person

• Domains are only used if you have that information about an AP

- i.e. APDM is not required in order to have APMH

• Supplemental Qualifiers for an AP dataset start with a prefix of “SQAP” rather than “SUPP”

- Example: SQAPSU, SQAPFAMH

How?! – General


● Domain labels must start with “Associated Persons”

● Any kind of exposure related variables are generally not used in AP domains

● Use timing variables with caution

• i.e. VISIT, EPOCH, RFXSTDTC

● Any ‘regular’ SDTM variables keep the xx suffix from APxx

• i.e. DMDTC still is DMDTC, not APDMDTC

● DOMAIN variable should match dataset name

How?! – Structure


How?! – APID


● Only needs to be unique within a study, but may be useful to have unique identifiers for

related studies

● When there is no relationship or the relationship is unknown, distinct APIDs should be used

• Incorporate unique elements such as subject IDs, domain codes, visit numbers

• Ex: DM_1, EX01

● APID identifies a single unit

• A unit could be defined as a person or a group

How?! – APID, cont.


How?! – POOLDEF


● Required if a pooled APID is used

● Identifies individual persons within a pooled APID

How?! – POOLDEF, cont.


- Example: testing a variety of blood samples from a blood bank for undesirable elements

- Each donor as an individual APID within the pooled APID, any test results for the pooled blood

would be under the pooled APID

- If there is a positive test then further tests would be needed on the individual blood samples to determine

which sample is positive

How?! – SREL


● Contains the relationship to the subject

● Uses RELSUB code list (extensible)

● “ACCIDENTAL ASSOCIATION” if there is no relationship or an accidental relationship

● Similar values can be used between SREL and EVAL

● SREL can account for multiple relationships

• If values “MULTIPLE” appear in SREL then a APRELSUB dataset is required

How?! – APRELSUB


● Contains definitions of all relationships when “MULTIPLE” is defined in SREL

● One AP can have multiple relationships to a single subject or a single AP can be related to

multiple subjects

● Often use of controlled terminology will require the use of APRELSUB

● Any APID with more than one relationship to a subject, device, or study must be represented

in APRELSUB

● Create APID in such a way to simplify process

How?! – APRELSUB, cont.






How?! – RSUBJID and RDEVID


● Null if AP is associated with the study rather than a subject or device

● RSUBJID: Populated with USUBJID of related subject or POOLID of the related pool (with

the definitions of the pool in POOLDEF)

● RDEVID: Populated with SPDEVID of the related device, only expected for device studies

● If the subject of a study is a device then RSUBJID would be null and RDEVID should be

populated

How?! – AP In Action – APDM


● Only created and submitted if demographics data is collected about APs in the study, not

required

● An APDM record for a pool should be included only if demographics data about the pool is

specifically collected

• Generally the individually identified persons within a pool (listed in POOLDEF) would have demographic data

and that is what should be presented in APDM

How?! – AP In Action – APMH, cont.






● APID can represent an individual or a group of people – even if these people are not

considered a “POOL”

● Note that the SREL value is singular, the number of people in the group is defined in the

SQAPMH as it is collected

How?! – AP in Action – APRP


● If subject is female, this would be in RP but if subject is MALE this would be in APRP

● SREL=“SEXUAL PARTNER”

• There is no CRF field which determines any other relationship so we cannot be more specific

● Apply CT if applicable to RPTEST and RPTESTCD

How?! – AP in Action – APRP, cont.


How?! – AP in Action – APSU


● Can be used to document family history:

How?! – AP in Action – APSU, cont.


● Could be used to document environmental exposure – substance use exposure from

household members

SREL SUOCCUR SUDOSE

SUDOSUSUDOSFRQ

How?! – AP in Action – APEX


● Accidental Exposure – when a study treatment is inadvertently exposed to a person who is

not in the study

How?! – AP in Action – APEX, cont.


● APEX – Accidental Exposure with a relationship to study subject

How?! – AP in Action – APAE


● APAE – Unanticipated serious adverse event for the operator

AETERM

AESTDTC

AEENDTC

AEENRF

AEACNOTHAESEV

AEOUT

AEREL

SQAPAE.QVAL where SQAP.QNAM=RELPROC

AESDTH

AESLIFEAESHOSP

AESDISAB

AESCONG

SREL

How?! – AP in Action – APAE


How?! – AP in Action – APAE, cont.


● AE Example 2:

● AE Example 3:

How?! – AP in Action – Pinnacle 21


● Using most recent version of Pinnacle 21 (v2.2.0 Pinnacle 21 Community):

● Domain name is truncated to 2 letters

● Unrecognized domain

● No checks performed whatsoever

How?! – Compliance Checks


● Check to make sure all of the AP required variables are populated:

• STUDYID, DOMAIN, APID, --SEQ, SREL

● Ensure all of the POOLIDs are represented in POOLDEF

● Ensure RDEVID is included as well as RSUBJID if there are any device related APs

● Ensure all APIDs are unique within the study

How?! – Compliance Checks, cont.


● Do a FREQ of SREL and ensure that the RELSUB code list is applied where applicable

● Ensure SREL formats are correctly created and that any values with derived multiple

relationships are represented

● Ensure that all “MULTIPLE” SRELs have a corresponding record in APRELSUB

● Ensure DOMAIN variable matches the domain name

How?! – Compliance Checks, cont.


● Ensure SQAP is used rather than SUPP

● Ensure the dataset label starts with Associated Persons

● Manually check all regular SDTM checks applicable to domain specific variables

• Specific rules apply for Events, Interventions, and Findings, and Special Purpose domains

Next Steps – ADaM Level AP


● Determine with which ADaM data structure the AP domain aligns the best

● If unique AP ADaM then named ADAPxx

● Always based on the analysis needs – how does this need to be summarized and/or listed?

● Pitfalls/Cautions

● Always be sure to detail your approach in ADaM Reviewer’s Guide

● Consult with the review panel at FDA

Any Questions?


● Michael Stackhouse

Associate Manager, Statistical Programming

Chiltern

Cary, NC

[email protected]

● Alyssa Wittle

Senior Statistical Programmer – 1

Chiltern

King of Prussia, PA

[email protected]

mailto:[email protected]

mailto:[email protected]

PharmaSUG SDE RTP 2016October 27, 2016

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