19 Course B: ADaM and Outputs

Eight evenings, two hours each, one per week. You start from the SDTM datasets built in Course A and build the analysis layer, the tables and figures on top of it, and the documents a regulator actually receives.

Before Evening 1

Course B assumes Course A, or equivalent experience. Specifically, it assumes you can read data/sdtm/ and know why those datasets look the way they do.

If you did not take Course A, work through SDTM Concepts and The DM Domain first, and complete Before You Begin: Setup. The SDTM datasets are committed in the repository, so you do not have to rebuild them.

19.1 The schedule

Ev	Session	What you build	Homework after
1	ADaM Concepts	Why analysis datasets are not SDTM rearranged; the two structures; traceability	Read ADSL background
2	ADSL	`adsl`: one row per subject, population flags, treatment dates	Exercise 4
3	ADAE	`adae`: occurrence data, treatment emergence, incidence denominators	Exercise 5
4	ADLB	`adlb`: parameters, analysis values, and the baseline every change is measured from	Exercise 6
5	Tables, Listings and Figures	A demographics table, an AE table, an SAE listing, an HbA1c figure	Exercise 7
6	Define-XML from a Specification Workbook	`define.xml` generated the way a sponsor does it, from a spec workbook	Exercise 9
7	The Analysis Data Reviewer’s Guide	The ADRG’s data-driven tables, and the conformance summary	Exercise 10
8	Dataset-JSON	The same data as `.xpt` and as Dataset-JSON, and what each format destroys	Exercise 11

19.2 How an evening runs

Identical to Course A. Two hours with a ten-minute break.

Time	What
0:00	Homework review and warm-up
0:10	Code along, first block
0:45	Short challenge in small groups
0:55	Break
1:05	Code along, second block
1:40	Discussion
1:52	Wrap and homework brief

Evenings 5 and 6 are the dense ones

Tables, Listings and Figures and the specification workbook session both carry more worked examples than the others. Expect those two evenings to move faster, and expect me to cut a worked example rather than run over. The book has all of them, so nothing is lost, and the cut example is always flagged so you know what to read.

19.3 What is expected between evenings

Roughly 45 to 75 minutes. The Part 3 exercises are harder than Course A’s, and Exercises 6 and 9 are the longest in the course.

The homework exercise from the table above
Reading the Background section of the next session beforehand

Sessions are not recorded

As in Course A. Nothing is recorded. If you miss an evening, work the session yourself in the book before the next one and do the homework exercise as your check.

If you get stuck doing that, ask in GitHub Discussions rather than waiting for the next evening.

19.4 What you will have at the end

Three ADaM datasets built and defended: adsl, adae, adlb
A tables-and-figures workflow that produces submission-shaped output from analysis data
A define.xml generated from a specification workbook, and a clear view of what that production route decides on your behalf
The ADRG’s generated tables, including a conformance summary with real findings in it
The same datasets in both transport formats, and a demonstrated distinction that one of them destroys

19.5 A word about what this course does not teach

It does not teach submission strategy, agency interaction, or what a reviewer will look for. Those require experience of running a submission. Where a topic needs that, the sessions say so rather than inventing plausible prose. See the scope note in The Analysis Data Reviewer’s Guide.