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Presentation Overview Consent Process + Documentation Participants in Informed Consent Process Logistics of Informed Consent is not just a document. Informed consent is also a PROCESSPROCESS + DOCUMENTATION
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What is consent process documentation?
Consent process documentation is a record of the steps taken to ensure that individuals have given informed consent to participate in a study or project.
Who is required to file consent process documentation?
Researchers, organizations, or institutions conducting studies or projects involving human subjects are required to file consent process documentation.
How to fill out consent process documentation?
Consent process documentation should be filled out by detailing how participants were informed about the study, the risks involved, their rights, and how their data will be used.
What is the purpose of consent process documentation?
The purpose of consent process documentation is to demonstrate that individuals have willingly agreed to participate in a study or project after being fully informed.
What information must be reported on consent process documentation?
Consent process documentation must include details of the informed consent process, participant rights, risks and benefits, data handling procedures, and contact information.
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