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PROTOCOL REGISTRATION MANUALOffice for Policy in Clinical Research Operations Division of AIRCRAFT Version 3.2
January 20181Contents
I.
Introduction ...........................................................................................................
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What is protocol registration manual?
Protocol registration manual is a document that outlines the detailed procedures and requirements for the registration of a protocol.
Who is required to file protocol registration manual?
Researchers and organizations conducting studies or experiments that involve human subjects are required to file a protocol registration manual.
How to fill out protocol registration manual?
Protocol registration manual can be filled out by following the guidelines and instructions provided in the manual.
What is the purpose of protocol registration manual?
The purpose of protocol registration manual is to ensure transparency, accountability, and compliance in research involving human subjects.
What information must be reported on protocol registration manual?
Information such as study objectives, study design, subject eligibility criteria, study procedures, and safeguards to protect human subjects must be reported on protocol registration manual.
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