Good Clinical Practice (GCP) Practice Exam

The purpose of confidentiality in clinical trials is primarily to prevent the disclosure of a sponsor's proprietary information and a subject's identity. This is critical for maintaining trust between participants and researchers, as individuals participating in clinical trials must feel secure that their personal information will not be disclosed without their consent. Confidentiality protects sensitive data that may be unique to the sponsor, such as specific methodologies or trade secrets that could impact competitive advantage in the market. Maintaining confidentiality is also a regulatory requirement, with guidelines established by organizations such as the FDA and the Declaration of Helsinki. Protecting participant identity ensures adherence to ethical standards by minimizing risks of stigmatization or discrimination based on the health data that could emerge from trial participation. Confidentiality contributes to the overall integrity of the research process, as participants are more likely to provide honest and complete information if they know their identities and sensitive data are safeguarded. This in turn leads to more reliable and valid study results.