Skip to main content

Posts

Showing posts from March, 2024

Featured Post

What is ADaM- Day:01 of Onco-ADaM project

ADaM, short for Analysis Data Model, transforms raw data into analysis-ready datasets, crucial for clinical research. While SDTM standardizes data, ADaM prepares it for analysis. Dive into the world of ADaM with me! Understanding its three key structures: 1. ADSL (Subject Level Analysis Dataset) ADSL: The backbone of analysis. 2. BDS (Basic Data Structure) ADLB, ADEX, ADEG, and ADVS: Building blocks for insightful analysis. 3. OCCDS (Occurrence Data Structure) ADCM, ADAE: Uncover critical occurrences for thorough analysis. To kickstart ADaM programming, essential documents include: 1. ADaM Implementation Guide ( ADaMIG ) 2. Protocol : The blueprint of study design and objectives. 3. CRF : Capturing crucial data points. 4. SAP : Guiding the analysis journey. 5. Mockup Shells : Visualizing dataset structures. 6. ADaM Specification : Navigating dataset creation. 7. Raw SDTM dataset : The foundation of analysis. In this project, armed with these documents, I started the journey by: 1. Prot...
Post a Comment
Read more

Creation of OCCDS-ADAE Dataset- Day 04 of Onco-ADaM Project

  Introduction This is a statistical analysis data structure that describes the general data structure and content typically found in occurrence analysis. For example like adverse events, concomitant medications, and medical history data structure. Some required variables for OCCDS are: Identifier Variables: STUDYID, USUBJID, — SEQ MedDRA Dictionary Coding Variables: — TERM Adverse Event Descriptive Variables: AESER(Serious Event) WHO Drug Dictionary Coding Variables: CMTRT ADAE stands for Adverse Events Analysis Dataset. The base datasets for ADAE is ADaM.ADSL, SDTM.AE, & SDTM.SUPPAE. Variables I am not including the general variables like USUBJID, SITEID, AGE, SEX, etc., and also not from ADSL. Note that the variables i mention is not limited to this. Adverse Event related variables AESPID AETERM AEDECOD ADECOD AEBODSYS AEBDSYCD AESTDTC AEENDTC AEACN AESHOSP AECONTRT AEREL AREL AEOUT AEENRF ASEV ASEVN AETOXGR AEDLTTOX AECMEDID Date ...
Post a Comment
Read more

Date & Time Imputation Variable

  Introduction In this post, I will elucidate the concept of Date and Time imputation. Date imputation involves the process of converting a partial date in ADCM, ADAE, and ADMH datasets to complete dates. This is necessary because the data are often collected based on subjects' memory, which can lead to incomplete entries. While in SDTM, the original data are retained, in ADaM, it becomes a critical step in data analysis. In dealing with Date and Time imputation, there exist numerous rules, particularly with regard to SAP requirements for date imputation in studies. Typically, the start and end dates and times are imputed. Furthermore, We always convert the character date into numeric when programming for ADaM. Before delving into this topic, I want to clarify that I haven't had exposure to time imputation yet. However, I assure you that I will provide insights on it as I gain exposure. Let's proceed with the discussion. For Start Date (—STDTC) If the day is missing ...
Post a Comment
Read more

Creation of OCCDS-ADCM Dataset - Day:03 of Onco-ADaM Project

Introduction This is a statistical analysis data structure that describes the general data structure and content typically found in occurrence analysis. For example like adverse events, concomitant medications, and medical history data structure. Some required variables for OCCDS are: Identifier Variables: STUDYID, USUBJID, — SEQ MedDRA Dictionary Coding Variables: — TERM Adverse Event Descriptive Variables: AESER(Serious Event) WHO Drug Dictionary Coding Variables: CMTRT ADCM stands for Concomitant Medications Analysis Dataset. The base datasets for this OCCDS is ADaM.ADSL and SDTM.CM. Variables I am not including the general variables like USUBJID, SITEID, AGE, SEX, etc., and also not from ADSL. Note that the variables i mention is not limited to this. Concomitant Med Related Variable CMTRT CMDECOD CMCAT CMSCAT CMINDC CMDOSE CMDOSU CMDOSFEQ CMROUTE CMSTDTC CMENDTC Analytical Therapeutical Chemical (ATC) code ATC1C ATC1T Date, Time & Impu...
Post a Comment
Read more

Creation of ADSL Dataset - Day:02 of Onco-ADaM Project

 Introduction Hey everyone, welcome to day 2 of the Onco-ADaM project! Today, I'll be working on creating the ADSL dataset, which is similar to DM for SDTM. Let's keep it short and simple. ADSL stands for Subject-Level Analysis Dataset, containing one record per subject regardless of the clinical trial design. The main dataset for creating ADSL is SDTM.DM. We won't include every variable, as that's not the purpose of ADSL. It's designed to include variables necessary for analysis only. ADSL includes demographic information, key date variables, randomization factors, planned and actual treatment variables, subject-level population flag, subgrouping variables, and baseline values. Variables in ADSL I am not including the general variables like USUBJID, SITEID, AGE, SEX, etc. Note that the variables I mention is not limited to this. a. Key Date variables RFICDT (Informed Consent Date) RANNDT (Randomization Date) TRTSDT (Treatment Start Date) TRTEDT (Treatment...
Post a Comment
Read more

What is ADaM- Day:01 of Onco-ADaM project

ADaM, short for Analysis Data Model, transforms raw data into analysis-ready datasets, crucial for clinical research. While SDTM standardizes data, ADaM prepares it for analysis. Dive into the world of ADaM with me! Understanding its three key structures: 1. ADSL (Subject Level Analysis Dataset) ADSL: The backbone of analysis. 2. BDS (Basic Data Structure) ADLB, ADEX, ADEG, and ADVS: Building blocks for insightful analysis. 3. OCCDS (Occurrence Data Structure) ADCM, ADAE: Uncover critical occurrences for thorough analysis. To kickstart ADaM programming, essential documents include: 1. ADaM Implementation Guide ( ADaMIG ) 2. Protocol : The blueprint of study design and objectives. 3. CRF : Capturing crucial data points. 4. SAP : Guiding the analysis journey. 5. Mockup Shells : Visualizing dataset structures. 6. ADaM Specification : Navigating dataset creation. 7. Raw SDTM dataset : The foundation of analysis. In this project, armed with these documents, I started the journey by: 1. Prot...
Post a Comment
Read more