Good Clinical Practice Q&As

摘要

In the FDA’s Information Sheet titled, “Recruiting Clinical Subjects,” the agency states that, “the first contact prospective study subjects make is often with a receptionist who follows a script to determine basic eligibility for the specific study. The IRB should assure the procedures followed adequately protect the rights and welfare of the prospective subjects. In some cases, personal and sensitive information is gathered about the individual. The IRB should have assurance that the information will be appropriately handled. A simple statement such as ‘confidentiality will be maintained’ does not adequately inform the IRB of the procedures that will be used.” “Examples of issues that are appropriate for IRB review: What happens to personal information if the caller ends the interview or simply hangs up? Does a marketing company gather the data? If so, are names, etc., sold to others? Are names of non-eligible subjects maintained in case they would qualify for another study? Are paper copies of records shredded or are readable copies put out as trash? The acceptability of the procedures would depend on the sensitivity of the data gathered, including personal, medical and financial.”