Background Story :

One day, my friend 99 discussed with me if a patient is randomized but not treated has some lab results besides screening, how should we classify the EPOCH variable for him/her in the SE domain? …

Background :

We finally we over the 5 study design trials, TA, TE, TI, TV, TS. As we mentioned last time, TS acts like the outline of the puzzle, how can we fit the puzzles together? What are the relations between these five datasets?

Rather than focusing on individual datasets, today we…

Background Story:

Recently my friend 77 told me they checked Trial Summary dataset for multiple rounds and fixed many miscellaneous issues. I wasn’t aware of the importance of the Trial Summary dataset until my colleague Jun told me FDA had a meeting emphasized on Trial Summary dataset on May.21.2021. So…


Today we will go over Trial Inclusion/exclusion dataset. The TI datasets contain all the inclusion and exclusion criteria for the trial, such as subject age, lab or other findings, or maybe medical history. We can fetch the info from IE(inclusion/exclusion) dataset specifications or protocol.

Note: TI is NOT subject-oriented.

Sample Spec:

Background Story:

So today we will go over the essentials of the Trial Visit dataset, which includes the planned visit in a trial in the structure of One record per planned Visit per Arm. It will have effects on SV (study visit) domain.

Key variables :

ARMCD: if visits are NOT the same…


Last time we went over TA, Today we will go over Trial Element dataset. The trial Element domain contains all the info regarding the Elements included in the study, therefore the administration of planned trials uses Element as the basic building block to describe the time periods without any…

Background :

Trial Design Datasets include TA (Trial Arms), TE (Trial Elements), TV (Trial Visits), TI (Trial Inclusion/Exclusion Criteria) , TS (Trial Summary) . These 5 Trial Design domains provided clear description of overall plan and design of the study. Today we will go over the basics for Trial Arms…

Background Story:

Once, we need to check a define file, one of my colleagues found many miscellaneous issues, such as punctuation, typos in algorithms, and variable is not on the correct CRF pages. I was surprised by how meticulous he worked. Define file is the critical document while filing an…

Background Story:

One day, my friend 77 asked me which one is more important ADRG (Analysis Data Reviewer’s Guide) or define.xml? I think define.xml focuses more on the ADaM dataset level, whereas ADRG provides an overview storyline for the study or additional info besides Define.xml.

I decided to summarize the…

Miss Discontinuity

Borderline mathematician

Get the Medium app

A button that says 'Download on the App Store', and if clicked it will lead you to the iOS App store
A button that says 'Get it on, Google Play', and if clicked it will lead you to the Google Play store