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admiralvaccine 0.3.0

Updates related to CBER requirements for eDiary data

• Updated ADFACE template and vignette as per new SDTM mapping of Investigator assessment for eDiary data, as recommended by CBER. The collection of the Investigator assessment can happen when data reported by the participants was deemed incorrect or the participant did not complete the eDiary. In these two scenarios, the Investigator assessment is collected within the eDiary platform as a separate record from the original data reported by the participant (if this is allowed by eCOA system) or in the study eCRF. This leads to a change in Solicited Adverse Event SDTM structure (FACE and VS). Additional records coming from Investigator assessment are added, which can be identified through an evaluator variable (FAEVAL/VSEVAL). An update in ADFACE has been provided in order to reflect these changes in SDTM. (#243)

Breaking Changes

• Removed dataset_supp and dataset_suppex arguments from derive_vars_merged_vaccine() as we are not combining parental with supplementary domains inside the function, but can be optionally combined in the ADCE, ADFACE and ADIS templates using combine_supp() function from {metatools}. (#246)

• Included an argument filter_add in derive_diam_to_sev_records() to pass the subset condition to consider the particular diameter record for convert them to severity records. (#243)

Updates to Templates

• Included a step to derive ANL01FL in ADFACE template, to flag the records which would be considered for analysis purpose. (#243)

• Supplementary domains are now optionally combined with parental domains in ADFACE and ADIS templates. (#246)

Updates to Documentation

• Included a step to derive ANL01FL in ADFACE vignette, to flag the records which would be considered for analysis purpose. (#243)

• Supplementary domains are now optionally combined with parental domains n ADFACE and ADIS vignettes. (#246)

Various

• {metatools} was added to ‘Suggests’. (#246)

admiralvaccine 0.2.0

Updates to Templates

• Modified calls to derive_vars_joined() in ADCE, ADFACE and ADIS templates in line with the updates to this function in the new version of the {admiral} package. The join_type argument is now always specified and populated as 'all' (#229).

• Modified calls to derive_extreme_records() in ADFACE template in line with the updates to this function in the new version of the {admiral} package. The filter argument is now renamed to filter_add and the argument dataset_add is now always specified. (#229).

Updates to Documentation

• Modified calls to derive_vars_joined() in ADCE, ADFACE and ADIS vignettes in line with the updates to this function in the new version of the {admiral} package. The join_type argument is now always specified and populated as all (#229).

• Modified calls to derive_extreme_records() in ADFACE vignette in line with the updates to this function in the new version of the {admiral} package. The filter argument is now renamed to filter_add and the argument dataset_add is now always specified. (#229).

• All dummy SDTM data used in the package, have been replaced with data available in {pharmaversesdtm} package (#228).

Various

• Website now has button/links to Slack channel and GitHub Issues (#225).

• Lee Armishaw was added as a contributor (#225).

admiralvaccine 0.1.0

New Features

• Created SDTM dummy data IS, SUPPIS for ADIS (#31, #26)
• Created SDTM dummy data DM, CE, EX, FACE, VS for ADCE AND ADFACE.
• Developed new functionalities for ADFACE, ADIS and ADIS domain.
• Added metatools, metacore packages in staged_dependencies.yaml file.
• Created template for ADSL.

Documentation

• Created ADIS vignette.
• Created ADCE vignette.
• Created ADSL vignette.
• Created ADFACE vignette.

These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.