science

Standard for Exchange of Non-clinical Data

Standard for Exchange of Non-clinical Data is a science topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand Standard for Exchange of Non-clinical Data rather than just read about it. In short: The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development.

Key takeaways

Standard for Exchange of Non-clinical Data belongs to science; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect Standard for Exchange of Non-clinical Data to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of Standard for Exchange of Non-clinical Data from memory before moving on to harder problems.

Reference excerpt

The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development. Raw data of toxicology animal studies started after December 18, 2016 to support submission of new drugs to the US Food and Drug Administration will be submitted to the agency using SEND. Having a common model to which the industry can conform enables benefits such as the ability for vendors to develop tools, for inter-organizational data exchange that is consistent in format regardless of the parties involved, and so on. A SEND package consists of a few parts, but the main focus is on individual endpoint data. Endpoints typically map to domains (essentially, datasets), with a number of variables (a.k.a., columns or fields).

Implementation The SEND Implementation Guide (SENDIG) is a document that provides implementers with specifications for implementing SEND, including how to model various nonclinical endpoints, rules to doing so, and examples with sample data. This document is available on the CDISC SEND website. Supplementing the guide is the SEND Implementation Wiki hosted by PhUSE designed to assist with the implementation process and filling in some of the gaps, most notably containing:

SEND, CT, and Define.xml Fundamentals pages – providing more approachable descriptions of fundamental concepts in SEND Getting SEND-ready – to help new implementers get started FAQ – providing a large, evolving list of commonly asked questions Companion to the wiki is the SEND Implementation Forum, which allows implementers to ask questions and get responses from SEND experts. New implementers are encouraged to ask questions here.

History The work on this standard began in July 2002—subsequently, a U.S. Food and Drug Administration pilot project was initiated in July 2003 through a Cooperative Research and Development Agreement (CRADA). Feedback from this pilot and continuous efforts to more closely align this implementation with the SDTM for human clinical trials led to development of SEND 2.3, but without widespread adoption. In 2006, with renewed FDA interest, the industry met to revive SEND and work on a version that, with FDA backing, would cover regulatory submission as well as operational data transfer needs. By 2007, an FDA pilot was announced, during which time the SEND team worked on the SENDIG (implementation guide). SENDIG 3.0 was released to production in July 2011. This was soon followed by the FDA's statement of preference for SEND datasets. In December 2014, the FDA CDER and CBER divisions released guidance for industry enforcing the usage of SEND as part of Investigational New Drug (IND) and Biologic License Application (BLA) submission to the US Food and Drug Administration. All studies started after December 15, 2016 supporting IND and BLA submissions will need to be compliant with SEND. The Pharmaceuticals and Medical Devices Agency in Japan will enforce its use in the future, most probably in 2020. The European Medicines Agency also expressed interest and is recommending the use of SEND. SENDIG 3.1 was released in June 2016, extending the format with new data domains. SENDIG-DART 1.1 was released in December 2017. SENDIG-DART is a standard which extends the SENDIG 3.1 standard for use with Segment II Development and Reproductive Toxicology Studies. Consider the SENDIG and the PhUSE SEND Implementation Wiki pages for additional related information.

Illustrations

Worked examples

Example 1 — a first encounter with Standard for Exchange of Non-clinical Data

Start with the simplest possible case. Write down what Standard for Exchange of Non-clinical Data claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Standard for Exchange of Non-clinical Data before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Standard for Exchange of Non-clinical Data ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Standard for Exchange of Non-clinical Data

In research: Standard for Exchange of Non-clinical Data appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses Standard for Exchange of Non-clinical Data in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: Standard for Exchange of Non-clinical Data is common in secondary-school and first-year university syllabi. It links to neighbouring topics Clinical trials, Health standards, so understanding it makes those chapters shorter.
In everyday life: Look for Standard for Exchange of Non-clinical Data outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

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How to study Standard for Exchange of Non-clinical Data in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Standard for Exchange of Non-clinical Data means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain Standard for Exchange of Non-clinical Data out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Standard for Exchange of Non-clinical Data in simple terms?

Why does Standard for Exchange of Non-clinical Data matter?

Because it connects several science ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Standard for Exchange of Non-clinical Data?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Standard for Exchange of Non-clinical Data.