"Responsible parties" (as defined in 42 CFR 11.10(a)) must comply with the applicable provisions of section 402(j) of the Public Health Service Act (PHS Act) and the applicable regulations in 42 CFR part 11. The statute and regulations set forth the requirements for responsible parties to submit registration and summary results information to the data bank for specified "applicable clinical trials" (ACTs) of drug products (including biological products) and device products.
ACTs are described in section 402(j)(1)(A) of the PHS Act and in 42 CFR 11.10(a). Any applicable clinical trial that (1) is initiated after September 27, 2007, or (2) was initiated on or before September 27, 2007, and was ongoing on December 26, 2007, must be registered with the data bank (see section 402(j)(2)(C) of the PHS Act and 42 CFR 11.22(a)). For ACTs that are required to be registered, 42 CFR 11.42 describes for which trials results information must be submitted (see 81 FR 65121 for summary table) and whether they must submit the results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the PHS Act or the results information specified in 42 CFR 11.48.
42 CFR 11.66 describes the potential legal consequences for responsible parties if they do not comply with the requirements to submit registration and results information on applicable clinical trials. Such potential legal consequences include civil or criminal judicial actions, civil monetary penalty actions, and grant funding actions.