ADaM Mapping Specification for ADRS | Deriving Best Overall Response (BOR PARAMCD) Step-by-Step
Автор: SAS 2 R Programming
Загружено: 2025-12-16
Просмотров: 86
Описание:
In this video, I explain how to create an ADaM mapping specification for the ADRS domain specifically for Best Overall Response (BOR – PARAMCD) in oncology clinical trials.
You will learn how to derive BOR by systematically using:
aCRF annotations
Raw source datasets
SDTM datasets (TR, RS, TU, etc.)
SAP / Protocol rules
This video walks through the end-to-end thought process required to document a clear, reviewer-ready ADaM mapping specification, which is essential for regulatory submissions and interviews.
🔍 Topics covered:
What is ADRS and where BOR fits in ADaM
Understanding BOR definition from the SAP
Identifying source data from aCRF and raw datasets
Mapping BOR from SDTM response domains
Handling assessment windows and confirmation rules
Creating PARAM / PARAMCD for BOR
Writing derivation logic and traceability
Common mistakes and best practices in BOR mapping
This video is especially useful for:
Clinical SAS Programmers
ADaM Programmers
Oncology trial programmers
CDISC interview preparation
Anyone working on ADRS and efficacy endpoints
📌 If you are preparing for interviews or working on oncology ADaM datasets, this video will help you understand both the concept and documentation approach.
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