WebOct 24, 2024 · This website provides resources for understanding and complying with this NIH policy and the federal regulations in Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) as implemented by 42 CFR Part 11 (Final Rule). Steps for NIH Applicants & Grantees The responsible party for an applicable clinical trial (ACT) must register the trial and submit results information. The responsible party is defined as: 1. The sponsor of the clinical trial, as defined in 21 CFR 50.3; or 2. The principal investigator (PI) of such clinical trial if so designated by a sponsor, grantee, contractor, or … See more Registration is required for studies that meet the definition of an "applicable clinical trial" (ACT) and either were initiated after September 27, 2007, or initiated on or before … See more The responsible party (that is, the sponsor or designated PI) for an ACT must submit the required clinical trial information no later than 21 days after enrollment of the first participant. See more
Section 801 Rethinking Clinical Trials® - Duke University
WebSection 801 of the Food and Drug Amendments Act, known as FDAAA 801, requires registration and results reporting on the government web site called ClinicalTrials.gov for studies that meet the definition of “Applicable Clinical Trial”. Click here to evaluate whether your study is an Applicable Clinical Trial (ACT) under 42 CFR 11.22(b).. Under the … WebIdentifying an “Applicable Clinical Trial” under FDAAA • This flowchart presents basic guidance on determining if a trial is considered an “applicable clinical trial” under … orangemen\u0027s day newfoundland
Changes from Current Practice Described in the Final Rule …
WebAn FDA Amendments Act (FDAAA) [1] provision mandating public disclosure of agreements that restrict the PI’s ability to disclose results became effective on September 27, 2008. ... (FDAAA), Section 801 (Pub L No. 110-85); FDA Modernization Act of 1997 (FDAMA), Section 113 (Pub L No. 105-115). ... WebMar 24, 2024 · FDAAA, Section 801, and the Final Rule (42 CFR Part 11) Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) refers to a federal … WebSection 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) requires subjects the results information for applicable clinical trials (ACTs) that were initiated since September 27, 2007, or that were ongoing while of December 26, 2007, is the product studied in the ACT be approved, approved, or cleared according the Food ... iphonex sim卡突然无效