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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.

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

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.

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

Implementing Electronic Data Capture (EDC) systems in Clinical Trials

Clinical Data Management Team

Clinical Trial Management Systems (CTMS) are an important part of every clinical trial. Selecting the right CTMS helps address inefficiencies on the operational side of research, such as clinical trial planning, preparation, performance and reporting. As more and more pharma and biopharma sponsors start to recognize the potential opportunities that exist with EDC-CTMS integration, there is a growing need to address the complex process of electronic data capture (EDC) implementation.

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Topics: CDISC, Case Report Form (CRF), Electronic Data Capture, eCRF, Outsourcing Solutions, CDISC CDASH, Clinical Data Management, Paper-Based Studies

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

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.

 

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

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

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.

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

The Promise of Electronic Data Capture - How Soon is Now?

Clinical Data Management Team

Do you remember where you were when you heard the slogan, ‘Cleaner data faster’? That was the promise of Electronic Data Capture (EDC). A brave new world. Those of us at the forefront of EDC, or Remote Data Entry as it really was, may well remember the change resistance demonstrated by various stakeholders combined with the enthusiasm of early adopters.

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Topics: CDISC, Phase I Studies, Case Report Form (CRF), Remote Monitoring, Remote Data Capture, Tablets, Electronic Data Capture, ePRO, e-Clinical, eCRF, Electronic Medical Record (EMR), Source Data Verification (SDV)

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

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