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Articles by Lesley J. Gordon
Cowardice and Combat in the American Civil War
by Lesley J. Gordon Cambridge and New York: Cambridge University Press, 2024. Pp. x, 317. Illus., maps, notes, biblio., index. $89.99.
Fall 2024 Archives
Skip to content Vol. 14, No. 3 Features Robert E. Lee’s Unwritten History Grant and Sherman did it. Hood and Longstreet and Johnston too. So why didn’t the Confederacy’s greatest general write a memoir of the war? By Stephen Cushman The Bloodiest Day How rank-and-file troops experienced the Battle of Antietam By D. Scott Hartwig The Zouave By 1861, Elmer Ellsworth had become a household name in much of America. How a friendship with Abraham Lincoln helped propel him to prominence. By Lesley J.
Dread Danger
Skip to main content Accessibility help Coming soon Publisher: Cambridge University Press Expected online publication date: June 2024 Print publication year: 2024 Online ISBN: 9781108679367 Subjects: Area Studies, American Studies, American History 1861-1900, Military History, History When confronted with the abject fear of going into battle, Civil War soldiers were expected to overcome the dread of the oncoming danger with feats of courage and victory on the battlefield.
CDISC standards in clinical research
The Clinical Data Interchange Standards Consortium (CDISC) is dedicated to the improvement of medical research through data standardization. CDISC has produced a suite of standards that should be used to standardize content from planning and data collection through to data analysis and reporting. The United States Food and Drug Administration (FDA) now requires studies to be submitted in this standardized format.
ODM standard for CRF design
Over the last few years, our industry has become familiar with CDISC standards. This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of submission standards such as SEND, SDTM, and ADaM. This post shines a spotlight on the lesser-known Operational Data Model (ODM) standard, which is often overlooked as it’s not required by any regulators. Why should you be interested in it?
An introduction to case report forms
Different types of CRFs A Case Report Form (CRF) is a printed, optical, or electronic document designed to record all information required to be reported to the sponsor on each trial subject. CRFs play a crucial role in helping to assess the safety and efficacy of clinical products. An electronic CRF (eCRF) is an electronic version of the traditional CRF stored in cloud-based systems such as clinical metadata repositories (CMDR) or Electronic Data Capture (EDC) systems.
4 Reasons Why You Shouldn't Ignore CDISC Data Standards
A quick recap: Who are CDISC and what do they do? The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that aims to maximise the impact of clinical research data by establishing and promoting the use of data standards. Basically, these standards make clinical data easier to understand and interpret.
What the Best Clinical Study Build Pros Do
Getting your clinical study designed and built ready for data collection takes A LOT of work and expertise… you’ve got to do all your CRF designs; keep up with protocol changes; add the annotations; make sure everything aligns with CDISC standards. And the list goes on, and on… But it doesn’t have to be this difficult… with the right technology you can be a clinical study pro and master clinical trial setup! So what do the best clinical study pros do?
The ryze-elluminate integration to maximise automation in clinical trials -
The integration of a Clinical Metadata Repository (CMDR) and a Clinical Data Repository (CDR) presents the opportunity to maximize automation across the end-to-end clinical trial lifecycle. It also affords the ability to leverage wider benefits that can’t be achieved through just one solution. But there’s no use in technology partnerships without tangible interoperability in place. There must be a live integration that’s ready for clients to use from day one.
Formedix launches Community Forum to support the clinical trial industry -
Glasgow, UK (24th November, 2021) – Formedix, a leading provider of clinical trial software solutions, announces the launch of the Formedix ryze Community, to provide their customers with a location to collaborate, expand their knowledge and share information. Through a range of tools, the ryze Community will support the pharmaceutical industry to streamline and enhance clinical trial set-up and build.
Formedix Partnered with CDISC to Give Free Access to CDASH-Compliant eCRFs -
Formedix and CDISC Join Forces to Provide Free Access to Ready-to-Use, CDASH-Compliant eCRFs for Accelerated Clinical Trial Set-Up Formedix, a leading provider of clinical trial software solutions, has collaborated with CDISC, the global clinical research data standards development organization, to create a novel portal providing free access to ready-to-use, CDASH-compliant, annotated electronic case report forms (eCRFs).
How the Formedix ryze Visual Define-XML Editor Gives You Faster Define -
Define-XML is the metadata that describes the content and formatting of submission datasets and the case report tabulation data. It’s needed to help reviewers understand the data they are reviewing. It’s based on the CDISC ODM standard and is a key requirement for electronic submissions to the FDA and PDMA. Creating a Define-XML requires a lot of programming expertise. It takes a lot of time. That’s why it’s so important to make the process as quick and easy as possible.
Is there a faster way to build clinical trials?
As you know, clinical trials can be complex. Industry standards are now required for clinical trial submission. This means even more associated costs, resources, time, and effort. The Formedix ryze clinical metadata repository (MDR) can help! So what can it do for you? In a nutshell, it can help you: How is this possible? Take studies and standards for example. Ideally, you want to manage them all in one place. Right? The Formedix clinical metadata repository lets you do just that.
An overview of CDISC standards
Formedix has been strong advocates for the use of CDISC data standards in clinical and non-clinical research for decades, ever since we realized how it could transform our business by enabling the rapid design and build of clinical trials. We quickly focused our company around the use of CDISC standards, and are now industry leaders in CDISC software, professional services, and training.
How do CDISC standards fit into the drug development process?
Introduction The clinical trial process is a long, expensive, complicated one that often ends in failure. This means that to have a successful outcome, careful decision making and planning are absolutely essential. And so are data standards! The FDA requires clinical study data to be submitted in a standardized format. This allows the FDA to receive, process, review and archive submissions efficiently. It also lets them explore research options by putting together data from multiple studies.
The best military history books about the Civil War and the soldiers who fought
Home American Civil War books Lesley's list Who am I? I have been reading, researching, writing, and teaching Civil War military history for nearly thirty years. I first became interested in soldiers and their experiences as a teen, and went on to earn a PhD in American History at the University of Georgia. I’ve always been fascinated by the anti-hero, and the ways in which everyday people coped (or failed to cope) with this violent conflict.
Formedix Expedites Clinical Trial Build with New Cloud Clinical MDR Suite -
Glasgow, UK – (March 29, 2021) – Formedix, a leading provider of clinical trial software solutions, announces the launch of ryze, an innovative all-in-one cloud-based clinical metadata repository (MDR) and study automation platform. ryze has been specifically developed to accelerate and streamline the design, build and submission of clinical trials, in compliance with the Clinical Data Interchange Standards Consortium (CDISC) and NCI Controlled Terminology.
How clinical trial software can be used to optimize clinical trials
Clinical trial software facilitates clinical trials from conception to finish. For example protocol management, CRF design, metadata management, and the collection, analysis, and submission of compliant clinical study data to regulatory authorities. The aim is to get quality clinical products to the market faster. Traditionally spreadsheets have been used to record and manage all the various aspects of clinical trials.
3 things you should know about ADaM standards
One of the most important standards when it comes to clinical trial submission is the Analysis Data Model (ADaM). It outlines how to create analysis datasets and associated metadata. This in turn allows a statistical programmer to generate tables, listings, and figures (TLFs) more easily and ensures traceability. That means that reviewers can review and approve a submission more quickly.
Using Define-XML for Dataset Design
In the past, sponsors submitting to FDA were required to submit a PDF describing their submission datasets. As we all know PDF is great for viewing on-screen or printing, but the information inside can’t be interpreted by a computer. Enter CDISC’s Define-XML model. Define-XML standardizes how to describe datasets in a machine-readable manner. It can be used to define any tabular dataset structure, though it’s primarily used to describe SDTM, ADaM, and SEND datasets for regulatory submission.
How a clinical metadata repository can help with data quality
Metadata comes from multiple sources and can be stored in different places, systems, and networks. It’s hard to track it down. When files are updated, new versions are created. So how do you know if you’ve got the latest version? How do you know if the quality is good enough? The easiest way is to use a clinical metadata repository! The only way to keep track is to use a clinical metadata repository.
Using SDTM, ADaM, and SEND for Regulatory Submissions
It’s a safe bet that most people’s first introduction to CDISC standards is through the Study Data Tabulation Model (SDTM). This is a content standard that ensures clinical data is submitted in a consistent manner, helping to reduce review time and facilitating cross-study analysis. Another content standard, the Analysis Data Model (ADaM), aims to perform a similar function for analysis datasets.
Automating clinical trials: Why it’s essential for success
Many companies in the life sciences industry are slow to adopt new technologies. This is down to greater costs, greater operational burden, and uncertainty with meeting the complex regulatory requirements put in place. However, there has been a lot of advancement in new and emerging technologies in recent years. The FDA has recognized their benefits and is increasingly supportive of their use. Running clinical trials costs a lot of money! Despite that, there’s no guarantee of success.
Why switch to automated CRF annotations?
What is an annotated CRF? Annotated CRF’s document the location in a database of the data collected for each question on a form. In other words, it’s a mapping between each item on a form to its corresponding variable contained within the corresponding dataset. Annotated CRFs are part of the mandatory CDISC submission deliverables to the FDA. So they’re a must! Their purpose is to provide traceability. They help FDA reviewers find the origin of variables in the submitted datasets.
Important factors to consider when working with CRFs
What’s the background on CRFs? A traditional paper case report form is known as a CRF (or paper CRF). An electronic case report form (eCRF) is the same as a CRF, except that it’s electronic. Both abbreviations tend to be used interchangeably, and are also referred to as forms. CRFs and eCRFs are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical products.
The Union Army Regiment That Survived Andersonville
More than 40 years after the Civil War ended, machinist George Q. Whitney, formerly a private in the 16th Connecticut Volunteer Infantry, helped to dedicate a monument to his state’s prisoners of war. The statue, nicknamed “Andersonville Boy,” was a duplicate; the original had been erected at the site of the former Confederate prison in Andersonville, Georgia in October 1907.
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