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

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

Clinical Programming Team

At the July 25th PhUSE Webinar Wednesday, Ethan Chen (Director, Division of Data Management Services and Solutions Office of Business Informatics, FDA CDER) gave us a glimpse of the FDA’s view on Technical Rejection Criteria for Study Data. Those that were at the US Connect Conference earlier in the year may have seen this already.

Read More
Topics: Define.xml, ADaM Datasets, CDISC Standards, SDTM, SAS Programming, FDA, CDISC, SDTM Domains, CDISC SDTM, CDISC Guidelines

First Steps in Laboratory Dataset in SAS

Clinical Programming Team

The laboratory dataset is one of the core safety datasets and, at first glance, it could appear intimidating, with multiple tests and visits per patient. This article will illustrate checks that are worth applying at the very beginning of programming work – these could be in addition to the standardized process of domain validation.

Read More
Topics: Laboratory Datasets, Safety Dataset, Statistical Programming, SAS Programming, SAS, Clinical Programming, CDISC Standards, CDISC SDTM, SAS Macros, SAS Datasets, SDTM, Case Report Form (CRF), SDTM Domains, CDISC Guidelines, CDISC

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.

Read More
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:

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

Performing CDISC Compliant Pharmacokinetic Analyses

Statistical Consultancy Team

 

The Clinical Data Interchange Standards Consortium (CDISC) is a global not-for-profit organization that develops standards to support the acquisition, exchange, submission, and archive of data in clinical research. The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

Read More
Topics: Statistical Programming, Pharmacokinetics and Pharmacodynamic, CDISC SDTM, CDISC, SDTM, Bioequivalence, PK Analysis, ADaM Datasets

SAS Business Intelligence - A Perceptive Vision in Clinical Trials

Clinical Programming Team
Tables, listings and figures are part of day to day clinical submissions. Hence it would be useful if statisticians/clients could easily analyse the study data through different time points. This allows for better decisions because you are able to view outputs while the study is on going, this visualisation during a study can allow for great efficiencies as decisions can be made earlier in the clinical trial.
Read More
Topics: Statistical Programming, CDISC SDTM, SDTM Domains, CDISC, SAS Programming, SDTM, PK Analysis, Visualization, SAS BI, SAS Business Intelligence, SAS Web Report Studio

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.

Read More
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.

Read More
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.

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

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

Most Read

Posts by Topic

Expand all