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RequestNotesStatus

User Inquiry: Yun Zhang <Yun.Zhang@modernatx.com>

From Yun: Hepatitis B screening panel includes Hepatitis B surface antigen, Hepatitis B Surface antibody, Hepatitis B core antibody. If those tests are only done at screening and not related to study interest disease.

If following IG 3.3 , all those 3 tests are mapped to MB. If following IG 3.4, will only antigen map to MB , those 2 antibody tests are mapped to IS ? But in this way the same panel test would be separated in two domains.  Do you have any suggestions ?


2024-02-22: team notes - we also talked about making a new variable called “Panel Testing” which would apply to all the specimen-based domains. In recent years we have seen other panel tests that would required tests to be mapped to, for instance, GF and MB. It would be nice to have a standard variable dedicated to grouping related records from the same panel test, instead of having to rely on CAT or linking variables.

RESOLVED

2024-02-22: Jordan sent the mockup example back to Yun.

Jordan Li Jordan needs to add this to Example Collection.

mb.xpt

mb.xpt

Row

STUDYID

DOMAIN

USUBJID

MBSEQ

MBLNKID

MBTESTCD

MBTEST

MBTSTDTLMBTSTOPOMBCAT

MBORRES

MBSTRESC

MBMETHODVISIT

MBDTC

1

ABC

MB

ABC-01-201

1

HBVP1
Hepatitis B Virus Surface AntigenDETECTION
HBV TRIPLE SCREEN PANEL

POSITIVE

POSITIVE
SCREENING2013-08-26

2

ABC

MB

ABC-01-203

2

HBVP1


Hepatitis B VirusINTERPRETATIONSCREENHBV TRIPLE SCREEN PANEL

ACUTE INFECTION

ACUTE INFECTION
SCREENING2013-08-26

3

ABC

MB

ABC-01-201

3

HBVP2
Hepatitis B Virus Surface AntigenDETECTION
HBV TRIPLE SCREEN PANEL

POSITIVE

POSITIVE
VISIT 12013-10-25

4

ABC

MB

ABC-01-203

4

HBVP2
Hepatitis B VirusINTERPRETATIONSCREENHBV TRIPLE SCREEN PANEL

ACUTE INFECTION

ACUTE INFECTION
VISIT 12013-10-25
$warningHtml

is.xpt

xx.xpt

Row

STUDYID

DOMAIN

USUBJID

SPDEVID

ISSEQ

ISLNKID

ISTESTCD

ISTEST

ISCAT

ISORRES

ISORREC

ISMETHOD

VISIT

ISDTC

1

ABC

IS

ABC-01-203

ABC001

1

HBVP1
Microbial-induced AntibodyHEPATITIS B VIRUS SURFACE ANTIGENHBV TRIPLE SCREEN PANELNEGATIVE

SCREENING

2013-08-26

2

ABC

IS

ABC-01-203

ABC001

2

HBVP1


Microbial-induced IgM AntibodyHEPATITIS B VIRUS CORE ANTIGENHBV TRIPLE SCREEN PANELPOSITIVE

SCREENING

2013-08-26

3

ABC

IS

ABC-01-203

ABC001

3

HBVP1
Microbial-induced Total AntibodyHEPATITIS B VIRUS CORE ANTIGENHBV TRIPLE SCREEN PANELPOSITIVE

SCREENING

2013-08-26
4ABCIS

ABC-01-203

ABC001

4

HBVP2
Microbial-induced AntibodyHEPATITIS B VIRUS SURFACE ANTIGENHBV TRIPLE SCREEN PANELNEGATIVE

VISIT 1

2013-10-25
5ABCIS

ABC-01-203

ABC001

5

HBVP2


Microbial-induced IgM AntibodyHEPATITIS B VIRUS CORE ANTIGENHBV TRIPLE SCREEN PANELNEGATIVE

VISIT 1

2013-10-25
6ABCIS

ABC-01-203

ABC001

6

HBVP2


Microbial-induced Total AntibodyHEPATITIS B VIRUS CORE ANTIGENHBV TRIPLE SCREEN PANELPOSITIVE


VISIT 1

2013-10-25
$warningHtml
$titleHtml

relrec.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALRELTYPERELID
1ABCMBABC-01-201MBLNID
MANY1
2ABCISABC-01-201ISLNKID
MANY1
$warningHtml
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