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r4subprofile

Regulatory Submission Profiles for Clinical Submission Readiness

v0.1.0 · Mar 3, 2026 · MIT + file LICENSE

Description

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.

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CRAN Check Status

2 NOTE
12 OK
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Flavor Status
r-devel-linux-x86_64-debian-clang OK
r-devel-linux-x86_64-debian-gcc OK
r-devel-linux-x86_64-fedora-clang OK
r-devel-linux-x86_64-fedora-gcc OK
r-devel-macos-arm64 OK
r-devel-windows-x86_64 OK
r-oldrel-macos-arm64 NOTE
r-oldrel-macos-x86_64 NOTE
r-oldrel-windows-x86_64 OK
r-patched-linux-x86_64 OK
r-release-linux-x86_64 OK
r-release-macos-arm64 OK
r-release-macos-x86_64 OK
r-release-windows-x86_64 OK
Check details (14 non-OK)
OK r-devel-linux-x86_64-debian-clang

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OK r-devel-linux-x86_64-debian-gcc

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OK r-devel-linux-x86_64-fedora-clang

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OK r-devel-linux-x86_64-fedora-gcc

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OK r-devel-macos-arm64

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OK r-devel-windows-x86_64

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NOTE r-oldrel-macos-arm64

package dependencies

Packages suggested but not available for checking:
  'r4subscore', 'r4subrisk'
NOTE r-oldrel-macos-x86_64

package dependencies

Packages suggested but not available for checking:
  'r4subscore', 'r4subrisk'
OK r-oldrel-windows-x86_64

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OK r-patched-linux-x86_64

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OK r-release-linux-x86_64

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OK r-release-macos-arm64

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OK r-release-macos-x86_64

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OK r-release-windows-x86_64

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Check History

NOTE 12 OK · 2 NOTE · 0 WARNING · 0 ERROR · 0 FAILURE Mar 9, 2026
NOTE r-oldrel-macos-arm64

package dependencies

Packages suggested but not available for checking:
  'r4subscore', 'r4subrisk'
NOTE r-oldrel-macos-x86_64

package dependencies

Packages suggested but not available for checking:
  'r4subscore', 'r4subrisk'

Dependency Network

Dependencies Reverse dependencies cli r4subcore rlang tibble r4subprofile

Version History

new 0.1.0 Mar 9, 2026