Supported authorities | Submission types per authority | Creating a submission profile | Comparing authority weights | Profile summary | Validating evidence against a profile | Study phase
Package: r4subprofile 0.1.1
Pawan Rama Mali
r4subprofile: Regulatory Submission Profiles for Clinical Submission Readiness
Defines submission profiles per regulatory authority with authority-specific pillar weights, decision thresholds, indicator requirements, and risk configuration. Supports the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Therapeutic Goods Administration (TGA), and Medicines and Healthcare products Regulatory Agency (MHRA). Integrates with 'r4subscore' and 'r4subrisk' configuration systems.
Authors:
r4subprofile_0.1.1.tar.gz
r4subprofile_0.1.1.zip(r-4.7)r4subprofile_0.1.1.zip(r-4.6)r4subprofile_0.1.1.zip(r-4.5)
r4subprofile_0.1.1.tgz(r-4.6-any)r4subprofile_0.1.1.tgz(r-4.5-any)
r4subprofile_0.1.1.tar.gz(r-4.7-any)r4subprofile_0.1.1.tar.gz(r-4.6-any)
r4subprofile_0.1.1.tgz(r-4.6-emscripten)
manual.pdf |manual.html✨
DESCRIPTION |NEWS
card.svg |card.png
r4subprofile/json (API)
| # Install 'r4subprofile' in R: |
| install.packages('r4subprofile', repos = c('https://r4sub.r-universe.dev', 'https://cloud.r-project.org')) |
Bug tracker:https://github.com/r4sub/r4subprofile/issues
Pkgdown/docs site:https://r4sub.github.io
Last updated from:bf904baba3. Checks:9 OK. Indexed: yes.
| Target | Result | Time | Files | Syslog |
|---|---|---|---|---|
| linux-devel-x86_64 | OK | 121 | ||
| source / vignettes | OK | 175 | ||
| linux-release-x86_64 | OK | 124 | ||
| macos-release-arm64 | OK | 93 | ||
| macos-oldrel-arm64 | OK | 74 | ||
| windows-devel | OK | 74 | ||
| windows-release | OK | 81 | ||
| windows-oldrel | OK | 72 | ||
| wasm-release | OK | 104 |
Exports:list_authoritieslist_submission_typesprofile_required_indicatorsprofile_risk_configprofile_sci_configprofile_summarysubmission_profilevalidate_against_profile
Dependencies:cligluejsonlitelifecyclemagrittrpillarpkgconfigr4subcorerlangtibbleutf8vctrsxml2
Readme and manuals
Help Manual
| Help page | Topics |
|---|---|
| List Supported Regulatory Authorities | list_authorities |
| List Submission Types for an Authority | list_submission_types |
| Print Profile Validation Result | print.profile_validation |
| Print Submission Profile | print.submission_profile |
| Get Required Indicators for a Profile | profile_required_indicators |
| Extract Risk Configuration from a Profile | profile_risk_config |
| Extract SCI Configuration from a Profile | profile_sci_config |
| Summarize a Submission Profile | profile_summary |
| Create a Submission Profile | submission_profile |
| Validate Evidence Against a Submission Profile | validate_against_profile |
