Table 3 - Patient Screening and Enrollment, Trials A and B
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huanlugwu commented
Table 3 provides an example of how screening and enrollment data should be displayed.
Reference: FDA-2022-N-1961-0002_attachment_1 on page 14.
Description
Patient Screening and Enrollment, Trials A and B
Analysis Datasets
ADSL
When using data from the scda
package, please use datasets with archive_name
set to "rcd_2022_10_13"
.
Analysis Filtering
The populations should be defined as follows:
- Screened population: All patients screened for entry into the trial
- Enrolled population: All patients who signed a consent form for participation in the trial
- Randomized population: All patients randomized to a treatment arm; often referred to as the intention-to-treat population
- If screening failure data are available, provide reasons for screen failure, such as “patient noncompliance,” “consent withdrawn,” “inclusion/exclusion criteria not met,” “other.” Request breakdown of “inclusion/exclusion criteria not met” and “other,” because understanding reasons for screen failure can be informative to assess the generalizability of the trial.
Column Variable
ARM
Additional Notes
N/A
huanlugwu commented
- Table Function: Create
R/fda-table_03.R
file with your table-generating function. - Roxygen Documentation: title,
@details
, document all parameters,@return
,@examples
,@export
. - Tests: Create
tests/testthat/test-table_XX.R
file with tests for the table function and then run these tests. - Quarto Template: Create
quarto/table-templates/template-table_03.qmd
file your table template. - Screenshot: Add table screenshot as
table_03.png
to thequarto/assets/images/screenshots
folder. - _quarto.yml: Add template to the "Template Library" section of the
_quarto.yml
file. - Template Index: Run
quarto/assets/generate-template_index.R
script to update the template index. - NEWS: Update
NEWS.md
.