federal_register: E8-28387

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E8-28387 Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials." This guidance clarifies FDA's position that it is critical that data be retained from trial participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, as applicable, or who were discontinued from participation by the clinical investigator. The guidance will be of interest especially to sponsors, clinical investigators, and members of investigational review boards (IRBs). 2008-12-01 2008 12 https://www.federalregister.gov/documents/2008/12/01/E8-28387/guidance-for-sponsors-clinical-investigators-and-irbs-data-retention-when-subjects-withdraw-from https://www.govinfo.gov/content/pkg/FR-2008-12-01/pdf/E8-28387.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials." This guidance clarifies FDA's position that it is critical that data be retained...

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