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DOCUMENTATION OF INFORMED CONSENT FOR INTERVENTIONAL CLINICAL TRIALS (21 C.F.R. 812.14, 812.20 and 312.62)Subject Name: DOB: Enrolling Investigator: IRB#: Protocol Version: ICF Version 1. The Informed
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How to fill out documentation of informed consent

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Step 1: Begin by clearly explaining the purpose of the documentation of informed consent to the participant.
02
Step 2: Provide the participant with all relevant information pertaining to the study or procedure, including risks, benefits, and alternatives.
03
Step 3: Ensure that the participant comprehends the information provided by encouraging them to ask questions and clarifying any doubts.
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Step 4: Allow the participant sufficient time to review the documentation and consult with others if desired.
05
Step 5: Once the participant has understood the information and voluntarily consents to participate, have them sign and date the consent form.
06
Step 6: Ensure that a knowledgeable witness also signs the documentation, confirming that the participant provided informed consent.
07
Step 7: Provide a copy of the signed documentation to the participant for their records.
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Step 8: Store the original documentation of informed consent securely and confidentially.

Who needs documentation of informed consent?

01
Documentation of informed consent is needed for any research study or medical procedure involving human participants.
02
It is essential for ensuring ethical and legal compliance as it demonstrates that the participant willingly agreed to participate after understanding the associated risks and benefits.
03
Researchers, medical professionals, and institutions conducting studies or procedures involving human participants must obtain informed consent.
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Documentation of informed consent is a written acknowledgment that a person has been informed about the risks and benefits of a medical treatment or research study, and has voluntarily agreed to participate.
Both the researcher conducting the study and the participant involved in the study are required to file documentation of informed consent.
Documentation of informed consent is typically filled out by the researcher or healthcare provider explaining the study or treatment, and signed by the participant indicating their understanding and agreement.
The purpose of documentation of informed consent is to ensure that participants are fully informed about the risks and benefits of a study or treatment, and that they have voluntarily agreed to participate.
Documentation of informed consent should include details about the study or treatment, potential risks and benefits, confidentiality, and the participant's right to withdraw at any time.
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