Category: Clinical Trial

ADSL

ADaM Day 1 In clinical trials, ADSL(Subject-Level Analysis Dataset) is the foundation of all ADaM analysis dataset, it is one record per subjects; it captures subjects’ population flag 🚩, treatment-related info, vital sign info♂, baseline disease info, and other info respect to different study designs.

Basic Oncology 101

  Today I will share some Basic Oncology Knowledge I found in my old notebook:  RECIST 1.1: Complete Response (CR): Disappearance of all non-nodal target lesion Partial Response (PR) : At least 30% decrease in the sum of diameters of target lesions compared with the baseline sum diameters.

ISS & ISE Info

  Background Story:       Once my friend said her team members cried during a meeting, i thought it was funny then. However, when I started to work in their team, I wanted to cry, too. What was the challenge? It was ISS/ ISE related work!  

SDTM.VS

SDTM day 6: Vital Sign Introduction: the Vital Sign domain captures all the measurements of body’s most basic functions, such as height, weight, blood pressure, heart rate… VS is a critical dataset in Drug Safety Analysis.

SDTM.EX

SDTM Day 5: SDTM.EX   Introduction: Exposure dataset contains the details of subjects’ study treatment information, it is one of the key safety datasets, and it is critical to efficacy analysis. The EX domain is intended for “protocol-specified study treatments” including placebo dosing. The EX dataset would present a complete and accurate of subjects’ exposure in one record per constant dosing to the reviewers.

SDTM.AE

SDTM Day 4 : SDTM.AE Adverse Event is an event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient, thus AE Dataset is very important to Safety analysis for drug testing. It captures Adverse Event dates and various Adverse Event information for each patient. The…

SDTM LB2

SDTM Day 3 : LB, Laboratory Dataset   Last Time we introduced SDTM.LB for laboratory Test Results in Finding General Observation Class and Showed an example of how to merge with SV(Subject Visit) to get Epoch. SDTM.LB is one of the most crucial datasets for Drug Safety Analysis, it could be challenging due to the vast amount of records. This…

SDTM QS

SDTM Day 2: QS Background: As the novice treatments for Cancer therapy have been developed, not only we care about prolonging the lives of patients, scientists also put their endeavor to improve the life qualities. SDTM.QS is designed for capturing the patients’ questions info. Definition: QS domain is a questionaries domain that contains a variety of patient information about different questionnaires. Such…

SDTM LAB1

  SDTM Day 1: SDTM stands for Study Data Tabulation Model. It is a standard structure for human clinical trial data submitted as a part of CDISC for FDA reviews. LB: Laboratory Test Results is one of Findings General Observation Classes. LB includes information such as, Laboratory Test Category(LBCAT), Laboratory Test Code(LBTESTCD), Lab Test Name (LBTEST), Unit, Lab Test Result, VISIT, Laboratory…

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