is_vaccine

An example SDTM IS for vaccine studies

dataset

A set of Study Data Tabulation Model (SDTM) datasets from the
Clinical Data Interchange Standards Consortium (CDISC) pilot project
used for testing and developing Analysis Data Model (ADaM) datasets
inside the pharmaverse family of packages. SDTM dataset specifications
are described in the CDISC SDTM implementation guide, accessible by
creating a free account on <https://www.cdisc.org/>.

Edoardo Mancini

pharmaversesdtm

SDTM Test Data for the 'Pharmaverse' Family of Packages

Fanny Gautier

Gayatri G

Kangjie Zhang

Lina Patil

Pooja Kumari

Sadchla Mascary

Stefan Bundfuss

Tomoyuki Namai

Vinh Nguyen

Vladyslav Shuliar

Zelos Zhu

is_vaccine function

A data frame with 24 columns:<dl>
<dt>STUDYID</dt>
<dd>Study Identifier</dd><dt>DOMAIN</dt>
<dd>Domain Abbreviation</dd><dt>USUBJID</dt>
<dd>Unique Subject Identifier</dd><dt>ISSEQ</dt>
<dd>Sequence Number</dd><dt>ISTESTCD</dt>
<dd>Immunogenicity Test/Exam Short Name</dd><dt>ISTEST</dt>
<dd>Immunogenicity Test or Exam Name</dd><dt>ISCAT</dt>
<dd>Category for Immunogenicity Test</dd><dt>ISORRES</dt>
<dd>Result or Finding in Original Units</dd><dt>ISORRESU</dt>
<dd>Original Units</dd><dt>ISSTRESC</dt>
<dd>Character Result/Finding in Std Format</dd><dt>ISSTRESN</dt>
<dd>Numeric Result/Finding in Standard Units</dd><dt>ISSTRESU</dt>
<dd>Standard Units</dd><dt>ISSTAT</dt>
<dd>Completion Status</dd><dt>ISREASND</dt>
<dd>Reason Not Done</dd><dt>ISNAM</dt>
<dd>Vendor Name</dd><dt>ISSPEC</dt>
<dd>Specimen Type</dd><dt>ISMETHOD</dt>
<dd>Method of Test or Examination</dd><dt>ISBLFL</dt>
<dd>Baseline Flag</dd><dt>ISLLOQ</dt>
<dd>Lower Limit of Quantitation</dd><dt>VISITNUM</dt>
<dd>Visit Number</dd><dt>EPOCH</dt>
<dd>Epoch</dd><dt>ISDTC</dt>
<dd>Date/Time of Collection</dd><dt>ISDY</dt>
<dd>Study Day of Collection</dd><dt>ISULOQ</dt>
<dd>Upper Limit of Quantitation</dd>
</dl>

Format

Immunogenicity Specimen Assessments for Vaccine — is_vaccine

A data frame with 24 columns:<dl>
<dt>STUDYID</dt>
<dd>Study Identifier</dd>

<dt>DOMAIN</dt>
<dd>Domain Abbreviation</dd>

<dt>USUBJID</dt>
<dd>Unique Subject Identifier</dd>

<dt>ISSEQ</dt>
<dd>Sequence Number</dd>

<dt>ISTESTCD</dt>
<dd>Immunogenicity Test/Exam Short Name</dd>

<dt>ISTEST</dt>
<dd>Immunogenicity Test or Exam Name</dd>

<dt>ISCAT</dt>
<dd>Category for Immunogenicity Test</dd>

<dt>ISORRES</dt>
<dd>Result or Finding in Original Units</dd>

<dt>ISORRESU</dt>
<dd>Original Units</dd>

<dt>ISSTRESC</dt>
<dd>Character Result/Finding in Std Format</dd>

<dt>ISSTRESN</dt>
<dd>Numeric Result/Finding in Standard Units</dd>

<dt>ISSTRESU</dt>
<dd>Standard Units</dd>

<dt>ISSTAT</dt>
<dd>Completion Status</dd>

<dt>ISREASND</dt>
<dd>Reason Not Done</dd>

<dt>ISNAM</dt>
<dd>Vendor Name</dd>

<dt>ISSPEC</dt>
<dd>Specimen Type</dd>

<dt>ISMETHOD</dt>
<dd>Method of Test or Examination</dd>

<dt>ISBLFL</dt>
<dd>Baseline Flag</dd>

<dt>ISLLOQ</dt>
<dd>Lower Limit of Quantitation</dd>

<dt>VISITNUM</dt>
<dd>Visit Number</dd>

<dt>EPOCH</dt>
<dd>Epoch</dd>

<dt>ISDTC</dt>
<dd>Date/Time of Collection</dd>

<dt>ISDY</dt>
<dd>Study Day of Collection</dd>

<dt>ISULOQ</dt>
<dd>Upper Limit of Quantitation</dd>


</dl>

Immunogenicity Specimen Assessments for Vaccine

ISTESTCD	ISTEST
I0019NT	I0019NT Antibody
J0033VN	J0033VN Antibody
M0019LN	M0019LN Antibody
R0003MA	R0003MA Antibody

is_vaccine: Immunogenicity Specimen Assessments for Vaccine

Description

Usage

Arguments

Format

Details