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Closes #121 Update eSubmission details with Pilot 5 information #123

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Merged
rossfarrugia merged 5 commits into from
Dec 15, 2025
Merged

Closes #121 Update eSubmission details with Pilot 5 information #123

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fccf5cc
Update eSubmission details with Pilot 5 information
bms63 Dec 5, 2025
50cabf3
Clarify feedback status in eSubmission document
bms63 Dec 5, 2025
a7684a4
Update WORDLIST with additional terms
bms63 Dec 5, 2025
f450674
Update esub/esub.qmd
bms63 Dec 14, 2025
b74d5b2
Revise Pilot 5 submission details and Dataset-JSON section
bms63 Dec 14, 2025
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10 changes: 7 additions & 3 deletions esub/esub.qmd
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Expand Up @@ -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 `xpt` with `datasetjson` as a transport file to the FDA via
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/).

## Submission Contents

The areas of eSubmission that pharmaverse packages are most useful for would be
Expand Down Expand Up @@ -153,9 +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

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2 changes: 2 additions & 0 deletions inst/WORDLIST
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Expand Up @@ -303,6 +303,7 @@ dy
dylib
DYTPE
ec
eCTD
ECENDAT
ECSTDAT
ectd
Expand Down Expand Up @@ -350,6 +351,7 @@ fansi
FAS
FASFL
fastmap
FDA's
fileext
flextable
flx
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