--- title: "Frequently Asked Questions" output: rmarkdown::html_vignette vignette: > %\VignetteIndexEntry{FAQ} %\VignetteEngine{knitr::rmarkdown} %\VignetteEncoding{UTF-8} --- ```{r setup, include = FALSE} knitr::opts_chunk$set( collapse = TRUE, comment = "#>" ) options(rmarkdown.html_vignette.check_title = FALSE) ``` Below are some frequently asked questions about the **defineR** package. Click on the links below to navigate to the full question and answer content. ## Index{#top} * [What is a define.xml?](#define) * [How do I generate a define.xml for ADaM?](#adam) * [Where can I get a metadata template?](#template) * [Can I generate a define.xml for SEND?](#send) * [Can I use my XPT files to generate a metadata file?](#xpt) * [Can I use other files to generate a metadata file?](#other) * [Does the package support define 2.1?](#version) * [What if I want to use a different XSLT style sheet?](#styles) * [Can it read in an existing define.xml?](#existing) * [Is this the same template as the SAS® toolkit?](#sas) ## Content ### What is a define.xml? {#define} **Q:** I don't quite understand what this is about. What is a define.xml? Do I need one? **A:** The define.xml is a special XML file used to describe data sent to regulatory bodies for drug applications. If you don't know what it is, then you don't need one. [top](#top) ****** ### How do I generate a define.xml for ADaM? {#adam} **Q:** The **defineR** generator seems to always create a define.xml for SDTM. I want to create one for ADaM. How can I do that? **A:** There is a parameter called `type` on the `write_define()` function that you can use to specify an SDTM or ADaM define. Here is an example: ``` # Get temporary directory for output tmp <- tempdir() # Create demo spreadsheet pth <- write_metadata(tmp, type = "adam", demo = TRUE) # Generate define for ADaM res <- write_define(pth, tmp, type = "adam") # View XML # file.show(file.path(tmp, "define.adam.xml")) # View check report # file.show(file.path(tmp, "check.adam.pdf")) # View HTML # file.show(file.path(tmp, "define.adam.html")) ``` [top](#top) ****** ### Where can I get a metadata template? {#template} **Q:** I'd like to try out **defineR**. Where can I get a starting template? **A:** You can generate a starting template. It it recommended to start with the demo template, rather than a blank template. To do that, set the `demo` option on the `write_metadata()` function. Like this: ```{r eval=FALSE, echo=TRUE} # Get temporary directory tmp <- tempdir() # Create metadata template write_metadata(tmp, type = "", demo = TRUE) ``` [top](#top) ****** ### Can I generate a define.xml for SEND? {#send} **Q:** I am working on an animal study, and need to generate a define.xml for SEND. Can **defineR** do that? **A:** Not at this time. If you desire this feature, please submit a request to the GitHub [issue list](https://github.com/dbosak01/defineR/issues). [top](#top) ****** ### Can I use my XPT files to generate a metadata file? {#xpt} **Q:** I have some XPT files already. Can I use them to generate metadata? **A:** Yes. Use the `write_metadata()` function, and supply the `src_dir` parameter with the directory that contains your XPT files. Like this: ```{r eval=FALSE, echo=TRUE} # Get temporary directory tmp <- tempdir() # Create metadata template write_metadata(tmp, type = "", src_dir = "") ``` [top](#top) ****** ### Can I use other files to generate a metadata file? {#other} **Q:** What if I don't have XPT files? Can I generate metadata from Excel files or SAS datasets? **A:** Not in the current release. If you desire this feature, please submit a request to the GitHub [issue list](https://github.com/dbosak01/defineR/issues), and we can up the priority. [top](#top) ****** ### Does the package support define 2.1? {#version} **Q:** Our organization is getting ready for define version 2.1. Does the **defineR** package support it? **A:** Not yet. Define version 2.1 will be coming in a future release. [top](#top) ****** ### What if I want to use a different XSLT style sheet? {#styles} **Q:** I have a custom style sheet, and want to use it with **defineR**. Can I do that? **A:** Yes. There is a global option to specify a custom style sheet. The option is called "defineR.xslt", and you can set it as follows: ```{r eval=FALSE, echo=TRUE} options("defineR.xslt" = "") ``` [top](#top) ****** ### Can it read in an existing define.xml? {#existing} **Q:** I have a define.xml alread and want to create a metadata template from it. Can this package do it? **A:** Not at this time. If there is sufficient interest in this feature, we can add it. [top](#top) ****** ### Is this the same template as the SAS® toolkit? {#sas} **Q:** This template looks similar to the template in the SAS® Clinical Standards Toolkit. Are they the same? **A:** No. The metadata template for the **defineR** package was taken from the book "Implementing CDISC Using SAS: An End-to-End Guide" by Chris Holland and Jack Shostak. This book was published by SAS Institute®, but the metadata format is different than what was used for the SAS® Clinical Standards Toolkit. [top](#top) ******