Get Clearcorrect Informed Consent & Agreement 2014

The following are the required elements for documentation of the informed consent discussion: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3) reasonable alternatives, (4) risks and benefits of alternatives, and (5) assessment of the patient's understanding of elements 1 through 4.

There's FLEX, MINI, ONE, TWO, THREE and UNLIMITED. Availability of treatment options may be limited in some regions. Contact your ClearCorrect or Straumann representative to find out what is available in your area. The choice is yours.

A consent form is a legal document that ensures an ongoing communication process between you and your health care provider.

The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research.

There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency. Doctors will give you information about a particular treatment or test in order for you to decide whether or not you wish to undergo a treatment or test.

Elements of the Informed Consent Document 10 of the GCP guidance). They include the purpose, duration, risks, benefits, costs and additional expenses of the trial; a description of the trial procedures; alternative care options; and volunteers' rights.

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.