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Page 1/2 HE 01/05/2016 V2.1 Customer Consent Document (CCD) HDFC Bank Avoid Policy Rejection. Fill out this form carefully. ADDENDUM TO ELECTRONIC PROPOSAL FORM Application Number SPECIFIED PERSON.
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Cient FAQ
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A document with important information about a medical procedure or treatment, a clinical trial, or genetic testing. It also includes information on possible risks and benefits. If a person chooses to take part in the treatment, procedure, trial, or testing, he or she signs the form to give official consent.
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Considerations in preparing the informed consent document: Elements of consent present. Complete explanations. Lay language. Protection of confidentiality. No unproven claims of effectiveness. Device studies include a statement that the study includes an evaluation of the safety of the test article.
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A copy of the consent document must be provided to the subject and the original signed consent document should be retained in the study records. Note that the FDA regulations do not require the subject's copy to be a signed copy, although a photocopy with signature(s) is preferred.
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A consent form should normally be used to record the consent process and a participant's agreement to take part in your study. A signature on a consent form alone does not constitute legal or ethical consent, for more guidance please visit our section on 'Principles'.
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If you prefer to write your own consent document, you may do so, but be sure to include all required elements of informed consent.
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Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks.
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The purpose of a consent form is to inform clients, patients, or subjects of what information you're obtaining, what rights they're waiving, and other pertinent details. They ensure that the lines of communication remain open among the parties and afford people the right to be informed.
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