Create submission package for analysis
Copies scripts, datasets or NLME models with related datasets into folder structure as required by FDA for submission. Define files are copied or created if possible, and a reviewer's guides is prepared in terms of rmd/docx file.
createSubmissionPack( specification, analysisname, pathroot = ".", logfile = "logfile.txt" )
Named vector with path(s) to folder(s) containing analysis scripts or NLME project
Name of the analysis folder
Path where submission package is created
File with notes on manual postprocessing information.
None. Datasets and programs are copied to the submission package folder structure and a log file with postprocessing information written.
For NLME models, the NONMEM control and output file or mlxtran, Monolix model file and output file will be copied to programs and the modeling dataset to datasets. Per default the modeling dataset given in the control file will be used, however, the user can also provide the path (datafiles). For scripts, it will be attempted to parse the description of the file from the file header if not given by the user. The structure of the created package is 'm5/datasets/analysisname/analysis/legacy' with subfolders 'programs' and 'datasets'. The reviewer's guide needs to be manually opened, adjusted, and stored as PDF. A logfile is giving an overview on files that were copied and potential actions that need to be done.
Other Output & Compliance: