CALL US +44 (0)1462 440 084 | +1 919-882-2016 | Contact | Submit RFI

Creating Custom or Non-Standard CDISC SDTM Domains

Clinical Programming Team

Within the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), standard domains are split into four main types: special purpose, relationships, trial design and general observation classes. General observation classes cover the majority of observations collected during a study and can be divided among three general classes:

Read More
Topics: Statistical Programming, CDISC Guidelines, CDISC SDTM, SDTM Domains, CDISC, Standardization, Clinical Programming

The Creation of ADaM Datasets for Pharmacokinetic (PK) Analysis [Video]

Clinical Programming Team

In this recorded presentation a member of the Quanticate's Statistical Programming Team explores the creation of two ADaM datasets; ADPC and ADPP for Pharmacokinetic (PK) Analysis.

 

Read More
Topics: Pharmacokinetics and Pharmacodynamic, CDISC Guidelines, CDISC SDTM, SDTM Domains, CDISC, Clinical Programming, SDTM, CDISC Standards, PK Analysis, ADaM Datasets

Using CDISC SDTM to Improve Cost and Quality in Integrated Summaries

Clinical Programming Team

 

 

Following on from our previous blog posts on Integrated Summary tips, another aspect that can be considered is the cost and quality of producing integrated summaries and how CDISC and CDASH can aid in reducing costs and improving quality for ISS ISE submissions.

Read More
Topics: Regulatory Requirements, CDISC Guidelines, CDISC SDTM, SDTM Domains, CDISC, ISS/ISE, FDA, Integrated Summaries, Integrated Summary of Safety, Integrated Summary of Efficacy, Standardization

CDISC SDTM v3.1.2 Theory and Application

Clinical Programming Team

A member of the Clinical Programming Team writes about their experience at the CDISC interchange in Brussels held on 11th-12th April 2011.

Read More
Topics: Statistical Programming, CDISC Guidelines, CDISC SDTM, SDTM Domains, CDISC, Standardization, Clinical Programming, SAS Programming, CDISC Interchange

Welcome to The Quanticate Blog

We aim to provide information and support written by our experienced staff. We want to share our knowledge and create an archive of information that you will be able to engage with, share and comment on.

Subscribe to Email Updates

Blog Suggestions

Posts by Topic

Expand all