From fccf5cc3c1354e3ea87f43588654b0f943a5cb03 Mon Sep 17 00:00:00 2001 From: Ben Straub Date: Fri, 5 Dec 2025 15:00:57 -0500 Subject: [PATCH 1/5] Update eSubmission details with Pilot 5 information Added information about Pilot 5 and its outcomes. --- esub/esub.qmd | 6 ++++++ 1 file changed, 6 insertions(+) diff --git a/esub/esub.qmd b/esub/esub.qmd index a1b0e442..b6d9908f 100644 --- a/esub/esub.qmd +++ b/esub/esub.qmd @@ -39,6 +39,12 @@ Since these pilots laid the foundation, several major pharma companies have submitted primarily using R to health authorities across the world, so this article includes a mix of learnings from the pilots and real submissions. +In early 2025, the R Submissions WG [launched Pilot 5](https://r-consortium.org/posts/submissions-wg-pilot5-pilot6-and-more/) +to explore replacing `xpts` with `datasetjson` as a transport file to the FDA via +the eCTD portal. The group successfully submitted the data package in early Fall of 2025 +and has received positive feedback. Stay tuned for updates on the +[Pilot 5 Website](https://rconsortium.github.io/submissions-pilot5-website/). + ## Submission Contents The areas of eSubmission that pharmaverse packages are most useful for would be From 50cabf3f6e5ac1920c6d199e261b19a5a5463e5d Mon Sep 17 00:00:00 2001 From: Ben Straub Date: Fri, 5 Dec 2025 15:02:49 -0500 Subject: [PATCH 2/5] Clarify feedback status in eSubmission document Updated text to include the FDA's final response in the eSubmission document. --- esub/esub.qmd | 4 ++-- 1 file changed, 2 insertions(+), 2 deletions(-) diff --git a/esub/esub.qmd b/esub/esub.qmd index b6d9908f..e790879e 100644 --- a/esub/esub.qmd +++ b/esub/esub.qmd @@ -42,8 +42,8 @@ article includes a mix of learnings from the pilots and real submissions. In early 2025, the R Submissions WG [launched Pilot 5](https://r-consortium.org/posts/submissions-wg-pilot5-pilot6-and-more/) to explore replacing `xpts` with `datasetjson` as a transport file to the FDA via the eCTD portal. The group successfully submitted the data package in early Fall of 2025 -and has received positive feedback. Stay tuned for updates on the -[Pilot 5 Website](https://rconsortium.github.io/submissions-pilot5-website/). +and has received positive feedback. Stay tuned for updates and the FDA's +final response - [Pilot 5 Website](https://rconsortium.github.io/submissions-pilot5-website/). ## Submission Contents From a7684a4b16dac68ea3c0a9493d500ed508d70523 Mon Sep 17 00:00:00 2001 From: Ben Straub Date: Fri, 5 Dec 2025 15:09:00 -0500 Subject: [PATCH 3/5] Update WORDLIST with additional terms Added new entries to the WORDLIST. --- inst/WORDLIST | 2 ++ 1 file changed, 2 insertions(+) diff --git a/inst/WORDLIST b/inst/WORDLIST index 7b81871a..a57298a7 100644 --- a/inst/WORDLIST +++ b/inst/WORDLIST @@ -303,6 +303,7 @@ dy dylib DYTPE ec +eCTD ECENDAT ECSTDAT ectd @@ -350,6 +351,7 @@ fansi FAS FASFL fastmap +FDA's fileext flextable flx From f4506746d8def03c5db269441a61dabe3e74da71 Mon Sep 17 00:00:00 2001 From: Ben Straub Date: Sun, 14 Dec 2025 15:35:12 -0500 Subject: [PATCH 4/5] Update esub/esub.qmd Co-authored-by: Ross Farrugia <82581364+rossfarrugia@users.noreply.github.com> --- esub/esub.qmd | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/esub/esub.qmd b/esub/esub.qmd index e790879e..781b3a00 100644 --- a/esub/esub.qmd +++ b/esub/esub.qmd @@ -40,7 +40,7 @@ submitted primarily using R to health authorities across the world, so this article includes a mix of learnings from the pilots and real submissions. In early 2025, the R Submissions WG [launched Pilot 5](https://r-consortium.org/posts/submissions-wg-pilot5-pilot6-and-more/) -to explore replacing `xpts` with `datasetjson` as a transport file to the FDA via +to explore replacing `xpt` with `datasetjson` as a transport file to the FDA via the eCTD portal. The group successfully submitted the data package in early Fall of 2025 and has received positive feedback. Stay tuned for updates and the FDA's final response - [Pilot 5 Website](https://rconsortium.github.io/submissions-pilot5-website/). From b74d5b27bd8a50b27a4e4f2df3831337a835c590 Mon Sep 17 00:00:00 2001 From: Ben Straub Date: Sun, 14 Dec 2025 15:37:24 -0500 Subject: [PATCH 5/5] Revise Pilot 5 submission details and Dataset-JSON section Updated timeline for Pilot 5 submission and clarified Dataset-JSON usage. --- esub/esub.qmd | 6 ++---- 1 file changed, 2 insertions(+), 4 deletions(-) diff --git a/esub/esub.qmd b/esub/esub.qmd index 781b3a00..776b7517 100644 --- a/esub/esub.qmd +++ b/esub/esub.qmd @@ -41,7 +41,7 @@ article includes a mix of learnings from the pilots and real submissions. In early 2025, the R Submissions WG [launched Pilot 5](https://r-consortium.org/posts/submissions-wg-pilot5-pilot6-and-more/) to explore replacing `xpt` with `datasetjson` as a transport file to the FDA via -the eCTD portal. The group successfully submitted the data package in early Fall of 2025 +the eCTD portal. The group successfully submitted the data package in early Q3 2025 and has received positive feedback. Stay tuned for updates and the FDA's final response - [Pilot 5 Website](https://rconsortium.github.io/submissions-pilot5-website/). @@ -159,9 +159,7 @@ As an alternative to xpt, we also have `{datasetjson}` which enables the emerging new submission data exchange standard Dataset-JSON detailed [here](https://www.cdisc.org/standards/data-exchange/dataset-json). As this package is still experimental, we don't include code examples here but over time -and as momentum grows we can add extra examples to this article. -See R Submissions WG [pilot 5](https://rconsortium.github.io/submissions-pilot5-website/) -for a pilot submission using Dataset-JSON. +and as momentum grows we can add extra examples to this article. ### Readable Code