Category: Clinical Trial

SDTM: SE Subject Element Domain

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 SE domain? So today we will go over a basic example for SE domain: Subject Element. Purpose: The SE stores treatment data linked together with…

Trial Design 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 will connect the 5 trial design datasets together…

TS: SDTM Trial Summary Domain

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 the basics for Trial Summary…

TI: SDTM Trial Inclusion/Exclusion Dataset

Background: Today we will go over Trial Inclusion/exclusion dataset. The TI datasets contains 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. 

TV: SDTM Trial Visit Dataset

Background Story: So today we will go over the essentials of the Trial Visit dataset, which include 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.

TE: SDTM Trial Element Dataset

Background: Last time we went over TA , Today we will go over Trial Element dataset. Trial Element domain contains all the info regarding the Elements included in the study, therefore administration of planned trials use Element as the basic building block to describe the time periods without any gaps.(Screening, Treatment, Followup). Each planned Element will have a corresponding beginning…

TA: Trial Arm dataset

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, it has the structure of one record per planned element…

ADRG: Analysis Data Reviewer’s Guide

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 general format for the ADRG document.

ADPSATA: Prior Systemic Anti-Cancer Therapy Dataset

Background: Systemic Anti-Cancer therapy is a collective to describe the treatment of cancer in conjunction with different categories therapies such as: Surgical Therapies, Radiation Therapy, Stem Cell Transplants, Other Anti-Cancer Therapy.  The ADPSATA: Prior systemic Anti-cancer Therapy dataset presented a key overview of patients’ prior systemic therapy treatments, which may lead to different efficacy endpoint for patients’ current treatments. 

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