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. A responsible party is required to submit results for applicable clinical trials that are required to be registered under 42 U.S.C 282(j)(2)(C) and 282(j)(3)(C) and 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.

FDAAA provision, 42 U.S.C. 282(j)(3)(E)(iii)-(vi), allows for delayed submission of results information with certification or an extension of the deadline for submission of results information with a written request. A certification for delayed submission of results information shall be completed if the responsible party is seeking initial approval or clearance of a drug or device or if the manufacturer of a drug or device has filed or will file within a year an application for approval or clearance of a new use (which is also the use studied in the clinical trial). An extension of the deadline for submission of results information may be provided if the responsible party submits a written request and demonstrates good cause for the extension and provides an estimate of the date on which the information will be submitted.

ClinicalTrials.gov is currently in the process of updating the data entry system to accommodate certifications and extensions as part of the Protocol Registration System (PRS). Until this feature is implemented, a responsible party must submit certification and extension information to register@clinicaltrials.gov. Additional details are provided below.

Temporary Instructions for Certification or Request for Extension

Electronic Submission Details: Please submit certification and extension information to register@clinicaltrials.gov with Subject line "Certification or Extension Request". The responsible party should include in the email the information below that is specific to either a certification or extension request. Any missing information may result in a delay in processing.

Certification

• ClinicalTrials.gov identifier of the applicable clinical trial to which the certification applies
• Unique Protocol ID
• Type of certification
  • Seeking initial approval of a drug or device
  • Seeking approval of a new use for the drug or device
• Name(s) of the drug (including biological products) or device for which approval ("initial" or "new use") is being sought
• If seeking approval for a new use, provide the existing approval number for the drug or device (e.g., NDA, BLA, or PMA number)
• Name and contact information of the responsible party

Extension

• ClinicalTrials.gov identifier of the applicable clinical trial to which the request for extension applies
• Unique Protocol ID
• Explanation that demonstrates good cause for the extension (Note: an example of a good cause may be that the blind is not yet broken and data are still being collected for other outcome measures)
• An estimated date on which results information will be submitted
• Name and contact information of the responsible party