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Merge pull request #215 from pharmaverse/214_update_full_form@main
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#214 Update full form for acronym
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ahasoplakus authored Jun 27, 2023
2 parents 8cc1705 + 89eb2f1 commit cbfd995
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3 changes: 2 additions & 1 deletion DESCRIPTION
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Expand Up @@ -33,7 +33,8 @@ Authors@R: c(
)
Description: Programming vaccine specific Clinical Data Interchange
Standards Consortium (CDISC) compliant Analysis Data Model (ADaM)
datasets in 'R'. Flat model is followed as per CBER guidelines for
datasets in 'R'. Flat model is followed as per
Center for Biologics Evaluation and Research (CBER) guidelines for
creating vaccine specific domains. ADaM datasets are a mandatory part
of any New Drug or Biologics License Application submitted to the
United States Food and Drug Administration (FDA). Analysis derivations
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4 changes: 2 additions & 2 deletions R/data.R
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#' Immunogenicity
#' Immunogenicity Specimen
#'
#' A SDTM IS dataset
#'
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#' @family dataset
"vx_adsl"

#' Supplemental Immunogenicity
#' Supplemental Immunogenicity Specimen
#'
#' A SDTM Supplementary IS dataset
#'
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2 changes: 1 addition & 1 deletion README.Rmd
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Expand Up @@ -81,7 +81,7 @@ version of {admiralvaccine} was released.

* Build a toolbox of re-usable functions and utilities to create vaccine-specific ADaM datasets in R in a modular manner.
* All functions are created based upon the ADaM Implementation Guide and aim to facilitate the programming of ADaM dataset standards.
* Initially the package will focus on creating the reactogenicity and immunogenicity domain following flat model as per CBER guidelines.In future we will make enhancements as we get updates on CBER.
* Initially the package will focus on creating the reactogenicity and immunogenicity domain following flat model as per Center for Biologics Evaluation and Research (CBER) guidelines.In future we will make enhancements as we get updates on Center for Biologics Evaluation and Research (CBER).

## Expectations

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6 changes: 4 additions & 2 deletions README.md
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Expand Up @@ -50,8 +50,10 @@ previous version of {admiralvaccine} was released.
- All functions are created based upon the ADaM Implementation Guide
and aim to facilitate the programming of ADaM dataset standards.
- Initially the package will focus on creating the reactogenicity and
immunogenicity domain following flat model as per CBER guidelines.In
future we will make enhancements as we get updates on CBER.
immunogenicity domain following flat model as per Center for
Biologics Evaluation and Research (CBER) guidelines.In future we
will make enhancements as we get updates on Center for Biologics
Evaluation and Research (CBER).

## Expectations

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17 changes: 2 additions & 15 deletions inst/WORDLIST
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ABLFL
ADCE
ADFACE
ADIS
Expand All @@ -21,18 +20,13 @@ CRITx
CUTOFFx
DIARE
DM
DT
DTYPE
Erythema
FACAT
FAOBJ
FASCAT
GSK
GlaxoSmithKline
Hsain
ISSLOQ
ISSTRESN
ISULOQ
Immunogenicity
LLC
MAXDIAM
MAXSEV
Expand All @@ -47,10 +41,7 @@ OCSWEL
PARCAT
Pre
Purna
RFENDTC
RFSTDTC
Reactogenicity
SDT
SDTM
SEV
SEVPAIN
Expand All @@ -59,7 +50,7 @@ SUPPIS
Subperiod
TAUG
TRTP
Vx
Vax
adce
adface
adis
Expand All @@ -69,16 +60,12 @@ der
eg
exprs
funder
immunogenecity
immunogenicity
metacore
metatools
optinal
pharmaverse
pre
reactogenecity
reactogenicity
sev
ungrouped
xportr
xpt
2 changes: 1 addition & 1 deletion man/admiralvaccine-package.Rd

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2 changes: 1 addition & 1 deletion man/vx_is.Rd

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2 changes: 1 addition & 1 deletion man/vx_suppis.Rd

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6 changes: 3 additions & 3 deletions vignettes/adface.Rmd
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Expand Up @@ -20,13 +20,13 @@ library(admiraldev)
# Introduction

This article describes about creating `ADFACE` ADaM dataset which is
part of Vaccine - Reactogenicity based on CBER guidelines.
part of Vaccine - Reactogenicity based on the Center for Biologics Evaluation and Research (CBER) guidelines.

See the below links for more information:

[CBER Guidelines](https://www.fda.gov/media/112581/download)
[Center for Biologics Evaluation and Research (CBER) Guidelines](https://www.fda.gov/media/112581/download)

[Vaccine TAUG](https://www.cdisc.org/standards/therapeutic-areas/vaccines/vaccines-therapeutic-area-user-guide-v11/html)
[Therapeutic Area Data Standards User Guide for Vaccines (TAUG-Vax)](https://www.cdisc.org/standards/therapeutic-areas/vaccines/vaccines-therapeutic-area-user-guide-v11/html)

Examples are currently tested using `ADSL` (ADaM) and
`face`, `vs`, `ex` (SDTM) inputs.
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