From aac3f5e69c574212eb63ec076975c2883a526ac8 Mon Sep 17 00:00:00 2001 From: Alexander Peltzer Date: Tue, 29 Oct 2024 12:48:23 +0100 Subject: [PATCH] Delete sites/docs/src/content/docs/guidelines/regulatory/devs.md --- .../docs/guidelines/regulatory/devs.md | 36 ------------------- 1 file changed, 36 deletions(-) delete mode 100644 sites/docs/src/content/docs/guidelines/regulatory/devs.md diff --git a/sites/docs/src/content/docs/guidelines/regulatory/devs.md b/sites/docs/src/content/docs/guidelines/regulatory/devs.md deleted file mode 100644 index a4ec04ea34..0000000000 --- a/sites/docs/src/content/docs/guidelines/regulatory/devs.md +++ /dev/null @@ -1,36 +0,0 @@ ---- -title: User and developer aspects - regulatory -subtitle: Developer and user specific documentation for regulatory aspects in nf-core -weight: 1 ---- - -## Scope - -This document intends to provide further context for maintainers and developers. - -## Validation & integrative testing - -- Scope : - This part of the document provides information on which features should be included with each pipeline, which would facilitate regulatory approvals: -- Features to include: - Pipeline level: - - Integration testing: an analysis of the test in the production environment with real data - - Compare the performance of the test system in your dataset with those - specifications defined by the user. This includes the following performance - characteristics: - • Accuracy - • Precision - if applicable • Reportable range - if applicable • Reference intervals/range (normal values) for the laboratory’s patient population -- [if applicable] Controls to be included to unit tests: - • Positive control - • Negative control - • Additional controls (for example PCR reagent controls, amplification control gene, calibration curve,... ) -- Set of expected results for all controls. -- Set assay acceptance criteria -- Set rejection criteria. - - - Add automated quality checks that will be stopping points for the pipeline, if fail. - -- Store results to an automated report / stats file -- Automate risk management based on results stored in the stats file