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Procedure Name: Informed Consent Procedure Subject: Clinical Research Linked Policy: Clinical Research Operations & Compliance PolicyNumber: SOP 13 v3.0 Effective Date: July 01,2004 Revised Date:

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How to fill out informed consent procedure

01

Explain the purpose of the study to the participant.

02

Provide all necessary information about the study including risks, benefits, and procedures involved.

03

Ensure the participant understands the information provided by allowing them to ask questions.

04

Have the participant sign the consent form indicating their voluntary agreement to participate.

Who needs informed consent procedure?

01

Informed consent procedure is needed for any research study involving human participants. This ensures that participants are fully informed about the study and voluntarily agree to participate.

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What is informed consent procedure?

Informed consent procedure is a process where individuals are given all relevant information about a particular treatment or research study, so they can make an informed decision about whether to participate.

Who is required to file informed consent procedure?

Researchers, healthcare providers, and organizations conducting studies or providing treatments that require informed consent are required to file informed consent procedure.

How to fill out informed consent procedure?

Informed consent procedure can be filled out by providing detailed information about the study or treatment, risks and benefits involved, and obtaining signatures from participants or their legal guardians.

What is the purpose of informed consent procedure?

The purpose of informed consent procedure is to ensure that individuals have all the necessary information to make an informed decision about participating in a study or treatment.

What information must be reported on informed consent procedure?

Information such as study objectives, procedures involved, potential risks and benefits, confidentiality agreements, and participant rights must be reported on informed consent procedure.

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