Creating a metadata profile for clinical trial protocols

Avril Palmeri; Rebecca Leary; Anando Sen; Ronald Cornet; Danielle Welter; Philippe Rocca-Serra

Creating a metadata profile for clinical trial protocols

Avril Palmeri, Rebecca Leary, Anando Sen, Ronald Cornet, Danielle Welter, Philippe Rocca-Serra

Research output: Other contribution

Abstract

The purpose of this recipe is to describe the process to define and standardize study and protocol-level (meta)data commonly collected in paediatric clinical trials, with the aim of making trial data more Findable through a common Interoperable metadata profile. The recipe details how to: - Collect & refine a list of representative variables - Represent protocol-level additional (meta)data in a complementary data model - Define extraction processes for populating variables of interest

Original language	English
Publisher	Elixir FAIR Cookbook
Number of pages	12
Place of Publication	Genève, Switzerland
Publication status	Published - 2023
Externally published	Yes

Access to Document

https://faircookbook.elixir-europe.org/content/recipes/interoperability/c4c-clinical-trials.html#Licence: CC BY

Cite this

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title = "Creating a metadata profile for clinical trial protocols",

abstract = "The purpose of this recipe is to describe the process to define and standardize study and protocol-level (meta)data commonly collected in paediatric clinical trials, with the aim of making trial data more Findable through a common Interoperable metadata profile. The recipe details how to: - Collect & refine a list of representative variables - Represent protocol-level additional (meta)data in a complementary data model - Define extraction processes for populating variables of interest",

author = "Avril Palmeri and Rebecca Leary and Anando Sen and Ronald Cornet and Danielle Welter and Philippe Rocca-Serra",

year = "2023",

language = "English",

publisher = "Elixir FAIR Cookbook",

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T1 - Creating a metadata profile for clinical trial protocols

AU - Palmeri, Avril

AU - Leary, Rebecca

AU - Sen, Anando

AU - Cornet, Ronald

AU - Welter, Danielle

AU - Rocca-Serra, Philippe

PY - 2023

Y1 - 2023

N2 - The purpose of this recipe is to describe the process to define and standardize study and protocol-level (meta)data commonly collected in paediatric clinical trials, with the aim of making trial data more Findable through a common Interoperable metadata profile. The recipe details how to: - Collect & refine a list of representative variables - Represent protocol-level additional (meta)data in a complementary data model - Define extraction processes for populating variables of interest

AB - The purpose of this recipe is to describe the process to define and standardize study and protocol-level (meta)data commonly collected in paediatric clinical trials, with the aim of making trial data more Findable through a common Interoperable metadata profile. The recipe details how to: - Collect & refine a list of representative variables - Represent protocol-level additional (meta)data in a complementary data model - Define extraction processes for populating variables of interest

M3 - Other contribution

PB - Elixir FAIR Cookbook

CY - Genève, Switzerland

ER -