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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

The Problems (and solutions) of Real World Data in the Pharma Industry

Clinical Programming Team

Our job as Real World Data programmers is to put the whole patient data, usually spread across multiple tables, into one coherent history. This might lead to some surprising discoveries such as: patients with records before birth/after death, patients changing sexes multiple times, and finding non-valid codes. Such discrepancies are usually pretty easy to classify as data issues and are easy to handle. On the other hand we might encounter real world data events that cannot be as easily classified and need special approaches such as; patient receiving multiple Rx’s for the same drug on one day, or receiving a new Rx’s before the previous runs out, patients visiting the Doctor’s office / Emergency Room during their hospital stays, patients changing wards/level of care multiple times during one hospital visit, and finding valid but non-billable codes in insurance claims data. In this post we share some commonly encountered problems (and our solutions) related to Real World Data analysis.

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Topics: Clinical Programming, Outcomes Research, Real World Data, Observational longitudinal databases

The Logic of a Clinical Research Organization Programmer

Clinical Programming Team

As a statistical programmer at a leading data focused Clinical Research Organization (CRO), we are requested to become involved with many programming activities on a daily basis, centred around dataset or display generation and quality control (QC). Having the opportunity to develop a process/system which can be used by others is rare. To build any system, a lot of in depth thought is required before any programming begins. We take the requirements and build a robust system to address each potential scenario that may arise, including some which should not.

Within this blog we will explain how statistical programmers can work through a simple request to build a robust system using logic, SAS, UNIX and experience. It will provide a flavour of how robust systems are built and other considerations. 

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Topics: Clinical Programming, SAS Programming, Quality Control, SAS Macros, Quality Process Improvement, SAS

The INTO Statement in PROC SQL to Create Macro Variables

Clinical Programming Team

A member of the Quanticate Programming team writes about their opinions of the INTO statement in PROC SQL.

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Topics: Clinical Programming, SAS Programming, Large Datasets, SAS Macros, PROC SQL

A Review of the Annual PhUSE 2016 Conference

Clinical Programming Team

A number of team members were able to represent Quanticate at the PhUSE 2016 annual conference in Barcelona. The PhUSE annual conference is an opportunity for programmers and statisticians to both learn from and share cutting edge knowledge with the pharmaceutical industry. This year, Quanticate presented on producing high quality SAS graphics using the advanced Graphical Template Language (GTL) to bring individual plots together to aid analysis without sacrificing any aesthetical properties in the process. Conference attendees were spoilt for choice with approximately 5 simultaneous presentations every half-hour across 15 streams in total. Here are some interesting presentations which the team enjoyed over the conference duration.

 

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Topics: Programming R, Clinical Programming, SAS Programming, Visualization, Conferences, SAS Graph

Creating High Quality Graphics in Clinical SAS Programming

Statistical Consultancy Team

Utilizing the newer SAS graphical procedures such as SGPLOT and SGPANEL rather than the original SAS Graph procedures is becoming more and more popular in statistical programming through their many user friendly utilities, such as overlaying multiple graphics and adding reference lines with ease. However, as with its predecessor, SAS Graph, any requirement for restructure of the graphical elements still proves to be relatively rigid when sticking to these core graphical procedures. This usually results in creating bespoke program code for each figure which undoubtedly takes time and also runs the risk of inconsistencies across figures.

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Topics: Clinical Programming, SAS Programming, SAS Graph, PROC Template

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

Celebrating Women in Science, Medicine and Mathematics

Marketing Quanticate

Happy International Women's Day! On this day, we wanted to celebrate the success of women within science, mathematics and medicine, and how they have helped shape the pharmaceutical industry in which we work. Without the hard work and success of these individuals, we may not be providing the level of healthcare currently available. Today, half of medical graduates are female, as well as doctors and top researchers, it is reported that the number of statisticians equals the number of men. Please read on to learn about some of the most influential women to celebrate international women’s day.

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Topics: Statistical Programming, Medical Writing, Clinical Programming, Drug Development, Nobel Prize, Women in Science

Outcomes Research Programming vs Traditional Clinical Trial Programming

Clinical Programming Team

Outcomes research aka health outcomes research, is the study of the end results of particular health care practices and interventions, in other words it is the study of what happens in the real world to patients when they are given a certain treatment or a certain method of care. Outcomes research studies are used to improve the quality and value of healthcare for patients.

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Topics: Statistical Programming, Clinical Study Design, Clinical Programming, Accessible Data, Big Data, Outcomes Research, Real World Data, Teradata SQL, Observation Longitudinal Database

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

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