Question is obtaining informed consent of an adult for a clinical study (any phase [ie, 1, 2, or 3]): When obtaining informed consent from a study participant, list 5 items which are required to be either documented in the informed consent form or during the actual process of obtaining consent (eg, when the study staff meets with a prospective study participant)

Question is obtaining informed consent of an adult for a clinical study (any phase [ie, 1, 2, or 3]): When obtaining informed consent from a study participant, list 5 items which are required to be either documented in the informed consent form or during the actual process of obtaining consent (eg, when the study staff meets with a prospective study participant). In addition, for each of the 5 items you identify, provide 2 justifications/reasons as to why those items are mandatory.

For every one of the 5 items you identify, each item of those 5 items must have 2 justifications.