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Exploring CDISC Analysis Data Model (ADaM) Datasets

Clinical Programming Team

Clinical Data Interchange Standards Consortium (CDISC) defines and manages industry level data standards that are widely used during the analysis, reporting and submission of clinical data. For instance, the Study Data Tabulation Model (SDTM) is the submission data standard into which raw study data are mapped and collated. ADaM is a companion standard for use with analysis data and it is best practice to use SDTM data as the source for these datasets. Doing this allows for the easy documentation of any data processing with Define-XML, the CDISC standard for data definition files.

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Topics: Traceability, CDISC SDTM, CDISC, Standardization, Adverse Events (AEs), Clinical Trial Documentation, Clinical Programming, SDTM, CDISC Standards, ADaM Datasets, Analysis Data Model, ADSL

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:

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

Efficient Data Reviews and Quality in Clinical Trials [Video]

Statistical Consultancy Team

This video is presented by Kelci Miclaus from SAS JMP who was a speaker at Clinical Data Live 2013. Her presentation was is titled: 'Efficient Data Reviews and Quality in Clinical Trials'.

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Topics: Bayesian Statistics, CDISC, FDA, Standardization, Remote Monitoring, Remote Data Capture, Source Data Verification (SDV), Randomization, SAS Programming, On-Site Monitoring, Serious Adverse Events (SAEs), Quality Control, Visualization, Additional Monitoring, Efficient Data Review, Fraud Detection, Patient Safety

14 Advantages of Data Centralization and Standardization in Clinical Trials

Clinical Programming Team

The most crucial element of all research and development in clinical trials is the data.  It is the end product of every experimental and clinical study and supports the label of every product on the market.  It is required for internal decision making, the achievement of regulatory approval, and for monitoring and ensuring the safety of any clinical drug or device in the market. 

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Topics: Clinical Trials, CDISC, Standardization, SDTM, Centralization

How a Centralized Approach to Data Impacts Clinical Study Design

Statistical Consultancy Team

 

In today’s environment, one of the keys to accelerating drug development decisions comes from ready access to historical data. The introduction of the Centralized Service Provision (CSP) enables data across study phases and programmes to be accessed as easily as within the same study, due to the commonality of structure.

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Topics: Standardization, Clinical Study Design, Centralization, Biostatistics Consulting, Visualization

CDISC SDTM Therapeutic Area Domains - a Rapidly Evolving Standard?

Clinical Programming Team

The CDISC SDTM model is considered the most stable of the CDISC standards: version 3.1.1 of the Implementation Guide (IG) was published in August 2005; 3.1.2 in November 2008 which has remained the accepted standard. However, in this year’s European Interchange, CDISC revealed an aggressive timeline of therapeutic area (TA) SDTM domain development. From slides 17 and 18 of the presentation you can see that 14 new TA domains are intended to be developed in 2012 alone. The overall goal is to standardise efficacy data elements from 57 TAs in 7 years.

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Topics: CDISC SDTM, SDTM Domains, CDISC, Standardization, Clinical Programming, Biomarkers, SDTM, CDISC Standards, Therapeutic Areas

CDISC European Interchange, Stockholm, April 2012 – a Summary

Clinical Programming Team

A member of the Clinical Programming Team writes about their experience at the CDISC European interchange in Stockholm held on 18th-19th April 2012.

As part of the CDISC European Interchange meeting, I contributed a presentation on how Quanticate have used the CDASH standards to facilitate data capture and transformation to the SDTM standard.

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Topics: CDISC SDTM, SDTM Domains, CDISC, Standardization, ADaM Datasets, CDISC CDASH, CDASH, CDISC Interchange, CDISC ODM

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.

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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.

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

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