Zdrowie i gospodarka · 01/12/2008

FDA Releases Guidance on Data Retention for Clinical Trial Participants Who Withdraw

The Food and Drug Administration (FDA) has released a guidance document titled "Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials," which outlines the agency's stance on data retention for participants who withdraw from clinical trials. The guidance aims to clarify FDA's position on this critical issue, particularly for sponsors, clinical investigators, and members of investigational review boards (IRBs).