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The regulations at 42 CFR 11.28 address which registration information requirements apply to which studies. The "Applicability of Requirements in 42 CFR Part 11" table may be used to evaluate whether the registration information requirements in 42 CFR Part 11 or section 402(j) of the Public Health Service (PHS) Act apply to specific studies. (81 FR 65121)
As outlined in the table, required registration information is determined by the study initiation date. The initiation date is the date on which the trial is initiated (i.e., the actual Study Start Date as defined in 42 CFR 11.10(b)(16). (81 FR 65120)
  • Study Start Date on or before September 27, 2007, and ongoing on December 26, 2007: Follow requirements in section 402(j)(2)(A)(ii) of the PHS Act.
  • Study Start Date after September 27, 2007 but before January 18, 2017: Follow requirements in section 402(j)(2)(A)(ii) of the PHS Act.
  • Study Start Date on or after January 18, 2017: Follow requirements specified in 42 CFR 11.28 of the final rule.