a form signed prior to surgery by the parent(s) or legal guardian(s) of a child under age 18, or by a patient 18 years of age and older, which explains everything involved in the surgery, including the possible risks.
a document prepared by the sponsor and the investigator for potential subjects; explains the clinical trial, including procedures and risks, to potential subjects
The document that describes the Clinical Trial in sufficient detail to help the potential Participant decide whether or not to Participate in a Clinical Trial.
a form signed by the patient prior to surgery which explains everything involved in the surgery, including its risks.
is a document which should disclose the risks, benefits and alternatives to a procedure (surgery).
A document created by the drug manufacturer (with the FDA's guidance) that outlines a patient's rights during participation in a clinical trial. It also discusses the potential risks and benefits associated with participation, including all available data on previous studies. An Informed Consent form must be signed by the patient or authorized caregiver before entrance into a study.
a document disclosing the risks, benefits, and alternatives
Form prepared for patients explaining risks involved in the surgery.
The complete and open discussion of all procedures, benefits, risks, and expectations of a clinical trial between clinical investigators and potential participants. The FDA requires all participants to sign an informed consent form before participating in a trial.