Category: E

Exclusion Criteria

A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study. Source:

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The number of participants in a clinical study. The “estimated” enrollment is the target number of participants that the researchers need for the study. Source:

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Principal indicator(s) used for assessing the primary question (i.e., hypothesis) of a clinical trial. A variable that pertains to the efficacy or safety evaluations of

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Any ingredient intentionally added to a drug or biologic that is not intended to have a therapeutic effect but may improve product delivery. Examples of

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Structured information part of the eCTD module 1 specific to the product and the application information (full name, applicant, regulatory activity, type of application, procedure

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Electronic Signature

[FDA] Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be the

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Efficacy Supplement

[FDA] A supplement to an approved application proposing to make one or more related changes from among the following changes to product labeling: Add or

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eCTD Validation Criteria

Criteria published by various Health Authorities that define technical criteria for accepting an eCTD submission. Validation criteria may apply to XML backbones, files, folder structures

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eCTD Backbone

The Submission XML Table of Contents file which provides an interface for industry-to-agency transfer of regulatory information that takes into consideration the facilitation of the

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An electronic version of a medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. For

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