1. Introduction

Crypto, a form of digital token or “coins” that exist on a distributed and decentralized ledger called a blockchain, is a popular investment nowadays.

A crypto is a collection of binary data which is designed to work as a medium of exchange. Individual coin ownership records are stored in a…

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?
So today we will go over a basic example for 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…

Background:

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…

Background:

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…

Miss Discontinuity

Borderline mathematician https://space.bilibili.com/394390651

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