diff --git a/README.md b/README.md index e5dfe87..f66c74a 100644 --- a/README.md +++ b/README.md @@ -2,7 +2,7 @@ The objectives of the **R Consortium R Submission Pilot 3** Project are: -1. Deliver a **publicly accessible** R-based Submission through the [eTCD portal](https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd) +1. Deliver a **publicly accessible** R-based Submission through the [eCTD portal](https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd) 1. Expand on the work done in [Submission Pilot 1](https://rconsortium.github.io/submissions-pilot1/), by now utilizing R to generate ADaM datasets. @@ -19,7 +19,10 @@ The website is divide into 4 sections that will walk you through our efforts: 1. **Project Background/Setup** - Scope of work, what we used and how we used it. 1. **Deliverables** - What was sent to the FDA - Cover Letter, TLFs, Datasets, ADRG. 1. **Conferences** - Proceedings from different conferences on Pilot Submissions -1. **WG Minutes and Regulatory Feedback** - Provides a menu of links in two sections. **Section 1**: Provides links to the monthly WG Meeting Minutes, and **Section2**: Provides a link to the Pilot3 Team Compilation of the Regulatory Review including the Pilot3 Team Interpretation(s) of the Regulatory Feedback as the Review Process continues. +1. **WG Minutes and Regulatory Feedback** - Provides a menu of links in two sections. + - **Section 1**: Provides links to the monthly WG Meeting Minutes + - **Section 2**: Provides a link to the Pilot3 Team Compilation of the Regulatory Review + - Pilot3 Team *Interpretation(s)* of the Regulatory Feedback (FDA Review Continues) ## Latest News diff --git a/inst/WORDLIST b/inst/WORDLIST index 64eb86d..79c1bb8 100644 --- a/inst/WORDLIST +++ b/inst/WORDLIST @@ -36,6 +36,6 @@ TLFs USUBJID WG adam -eTCD +eCTD pharmaverse px