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…

SAS INTNX Function for Missing Date

Background Story: Missing dates are something the pharmaceutical industry deals with on a daily basis.  There are some common methods. Completely missing year, month, and day then no imputation. Set a certain number( ex.Jan01) for missing month and day Compare with treatment start date, and manipulate accordingly. If the AE start date and the treatment start date have the same…

窗边的小豆豆

Book 2 NJ, April 2021 很多年前展览管开书市的时候我买了这本书,粉色封面的。但是我翻了几页就没有读过了。 今年读完,这哪里是儿童读物?这明明就是人生箴言啊。日本的这些儿童读物真的是哀伤,明亮又温暖。 书里有要我们好好吃饭的山的味道,海的味道。有做事的习惯,用完就放回去。要锻炼身体的韵律操。有学海无涯的多多读书。有友情,帮助明爬树。有朦胧的crush,明天还要给阿泰修铅笔. 有对梦想承诺的一言为定。有对自己热爱的事情的不妥协,我不想用我的提琴奏军曲。有关键对话的,可不可麻烦你不要带蝴蝶结来上学,因为美代会要。有洛基和明的离别,那是求而不得没有办法的事。有懂得欣赏别人,也回来爱自己的天鹅舞虽然好,但也可以试着喜欢自己创造的舞蹈!还有小林校长包涵了一颗原子弹的温柔,小豆豆,你真的是个好孩子!

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