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HRSO – 100.02 – 2023
Draft Standard
Draft Standard HRSO - 100.02 - 2023
Development of a Training Program for Human Research Protection
Thank you for contributing your expertise to this draft standard.
The Technical Requirements and associated Annexes of this draft standard are open for comments. You can expand and collapse sections by clicking on the section titles as you review the document. In order to provide comments, please choose "I would like to comment" at the end of the section in order to open a comment box.
If you are unable to review the draft standard in one session, please submit the comments that you have in this session, and complete your review in a new session. The public consultation for this draft standard is from February 1, 2023 to April 3, 2023.
Please be sure to submit your full name and a valid email address as the HRSO Technical Committee will respond to all comments that are relevant and appropriate to the draft standard subject matter.
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Table of Contents
Technical Committee Members
Introduction
1. Scope
2. Normative References
3. Terms and Definitions
4 Technical Requirements
4.1 The Importance of HRP Training
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4.2 Administration of the HRP Training Program
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4.3 Fundamental Principles of HRP
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4.4 Application of the Fundamental Principles of HRP to the Human Research Lifecycle
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4.5 Testing of Learners
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4.6 Evaluating the Performance of the HRP Training Program
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Informative Annexes
Annex A: Examples of the Various Roles Individuals Play in Human Research (Informative)
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Annex B: Examples of how the Fundamentals Principles of HRP Apply to the Activities in the Human Research Lifecycle (Informative)
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Annex C: Informative References
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General Comments
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