Which aspect is addressed by 21 CFR 54?

21 CFR 54 specifically focuses on financial disclosure by clinical investigators involved in the research of products intended for human use. This regulation sets forth the requirements for clinical investigators to disclose any financial interests or arrangements with the sponsors of a study. The goal is to minimize conflicts of interest that may bias the research results and ensure the integrity of the data collected during clinical trials.

By mandating this disclosure, the regulation aims to provide transparency to the public and regulatory authorities about the financial relationships that may influence an investigator’s judgment or the outcome of the study. This is crucial in maintaining the credibility of the clinical research process and safeguarding the integrity of findings that inform health decisions.

Other aspects such as data confidentiality, GCP training for researchers, and adverse event reporting are addressed in separate regulations or guidelines. Though these components are also vital to research involving human subjects, they fall outside the specific focus of 21 CFR 54.