Delayed Submission of Results

Under 42 U.S.C. 282(j)(3)(E)(i) & (ii), a responsible party is required to submit "basic results" information not later than one (1) year after the earlier of the estimated or actual completion date (Primary Completion Date) of the trial. Results are to be submitted for applicable clinical trials that are required to be registered under 42 U.S.C 282(j)(2)(C) and that include drugs that are approved under section 505 of the Federal, Food Drug and Cosmetic Act (FDCA) or licensed under section 351 of the Public Health Service (PHS) Act or devices that are cleared under section 510(k) of the FDCA or approved under section 515 or 520(m) of such Act.

42 U.S.C. 282(j)(3)(E)(iii)-(v) allows for delayed submission of results information with certification.* A responsible party may submit a certification for delayed submission of results information for an applicable clinical trial that is:

• completed before the drug or device is initially approved, licensed, or cleared by the FDA ("seeking initial approval") or
• studying a new use of an FDA-approved drug or device (i.e., a use not included in the labeling) for which the manufacturer of a drug or device is the sponsor of the trial and has filed or will file within a year an application to the FDA for approval or clearance of that use ("seeking approval for a new use")

42 U.S.C. 282(j)(3)(E)(vi) allows the Director of NIH to provide an extension of the deadline for submission of results information for an applicable clinical trial if the responsible party submits a written request that demonstrates good cause for the extension and provides an estimate of the date on which the results information will be submitted. Pending publication is not considered a good cause for an extension.

It is expected that for any applicable clinical trial that is required to be registered with ClinicalTrials.gov under 42 U.S.C.282(j)(2)(C) the responsible party will submit basic results information, a certification, or a request for extension not later than one (1) year after the earlier of the estimated or actual completion date (Primary Completion Date) of the trial.

Certifications or Requests for Extensions are submitted via the Protocol Registration System (PRS). A study must have a valid protocol registration with an assigned ClinicalTrials.gov Identifier (NCT number) prior to submission of delayed results information. Information regarding Certifications and Requests for Extension may be displayed publicly as part of the protocol record.

* Note that if a manufacturer makes a certification under 42 U.S.C(j)(3)(E)(iii) ("seeking initial approval" or "seeking approval of a new use"), the manufacturer shall make such a certification with respect to each applicable clinical trial that is required to be submitted in an application or report for licensure, approval, or clearance of the use studied in the clinical trial.