Author: fangya

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. 

ADSPM: Second Primary Malignancy Dataset

Background Story: One day, I need to validate a SPM related files and ADSPM in a hematology study, I communicated with an experienced colleague many times and finally got the work done. Since each study has different data structure, there is  no standard SPM process  available for all. I will share my experience with SPM work, hopefully it is helpful…

ADLB avisitn

Background Story: In ADLB avisitn means analysis visit number sequence, most of the time it is a standard variable, such that each Visit or Visname maps to a corresponding number. However we had a study with convoluted raw data, in which multiple visits were recorded on the same day or many additional visit.  Today we will go over a basic…

AESI: Adverse Event of Special Interest Mapping

Background Story: One day, I validated an AESI(adverse event of Special Interest) data, I found a discrepancy between two output datasets. After I notified my boss, she suggested checking the AESI excel sheet, and it turns out both versions are partially correct. Because the Prefered term Hepatic Failure belongs to both Hepatic Disorder and Hepatic Failure EOI in a particular…

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