Sites May Retain, Analyze Data After Subjects Leave a Trial

If a trial subject withdraws from a research study or is terminated by the investigator, sites may retain and analyze data already collected from the subject, even if the data include identifiable private information, according to a new guidance issued by HHS’ Office of Human Research Protections (OHRP). The guidance is intended to harmonize OHRP’s data retention requirements with those of the FDA for sites conducting HHS-supported research that also is regulated by the FDA.
Clinical Trials Advisor