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Why do a 3rd of Regulatory Submissions fail the Technical Rejection Criteria?
by Clinical Programming Team
publish date icon August 6, 2018

Why do a 3rd of Regulatory Submissions fail the Technical Rejection Criteria?

This blog post looks at the FDA's Technical Rejection Criteria for Study Data and despite demographic dataset (DM for SDTM submissions), define.xml, the Subject-Level Analysis Dataset (ADSL for ADaM submissions) and Trial summary (TS) being...

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First Steps in Laboratory Dataset in SAS
by Clinical Programming Team
publish date icon June 27, 2018

First Steps in Laboratory Dataset in SAS

The laboratory dataset is one of the core safety datasets and, at first glance, it could appear intimidating. This article will illustrate checks that are worth applying at the very beginning of programming work – these could be in addition...

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Exploring CDISC Analysis Data Model (ADaM) Datasets
by Clinical Programming Team
publish date icon March 30, 2016

Exploring CDISC Analysis Data Model (ADaM) Datasets

A Quanticate blog post exploring Analysis Data Model and ADaM Datasets, and how it is widely used in the submission of clinical trial information.

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