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Study Data Specifications Study Data Specifications Revision History Date Version 2004-07 1.0 2005-03-18 1.1 2006-03-04 1.2 2006-11-27 1.3 2007-08-01 2009-11-03 1.4 1.5 Version 1.5 Summary of Changes

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What is study data specifications?

Study data specifications are guidelines and requirements for how data from a study should be collected, organized, and reported.

Who is required to file study data specifications?

The principal investigator or sponsor of a study is usually required to file study data specifications.

How to fill out study data specifications?

Study data specifications are typically filled out according to the guidelines provided by the regulatory body overseeing the study.

What is the purpose of study data specifications?

The purpose of study data specifications is to ensure that data from a study is collected and reported in a standardized and consistent manner.

What information must be reported on study data specifications?

Study data specifications typically include information on data collection methods, variables to be measured, and data analysis procedures.

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