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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...

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. Protocol & SAP Analysis: Delving into study objectives and planned analysis.
2. Mapping Specification: Unraveling dataset structures and variable requirements.
3. Programming Initiation: Initiating ADSL dataset creation, with more to unfold...

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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...