4 Extension Request DED & PRS Forms

Attachment 7

25 Oct 2022

Attachment 7 – Request for the Extension of the Results Information Submission Deadline

ClinicalTrials.gov Results Data Element Definitions
for Interventional and Observational Studies
February 1, 2021
8. Delayed Results (Optional)
A responsible party may delay the deadline for submitting results information if one of the two
certification conditions below applies to the clinical study and the certification is submitted prior to the
date of (i.e., the day before) the standard submission deadline for results information. The standard
submission deadline for results information is no later than 1 year after the ACT's primary completion
date. Alternatively, the responsible party may request an extension of the results submission deadline for
good cause. The extension must be granted by the NIH Director.
Delay Results Type [*] : Select one
•

Extension: Request, for good cause, an extension of the deadline for submitting results
information

Note: If a responsible party who is both the manufacturer of the drug product (including a biological
product) or device product studied in an applicable clinical trial and the sponsor of the applicable clinical
trial submits a certification under "Certify New Use," that responsible party must submit such a
certification for each applicable clinical trial that meets the following criteria: (1) the applicable clinical
trial is required to be submitted in an application or premarket notification seeking approval, licensure, or
clearance of a new use; (2) the applicable clinical trial studies the same drug product (including a
biological product) or device product for the same use as studied in the applicable clinical trial for which
the initial certification was submitted. [42 U.S.C. 282 (j)(3)(E)(v)(II) and 42 CFR 11.44(b)(3)]
Requested Submission Date [*] (Required when Delay Results Type is "Extension.")
Definition: Estimate of the date on which the clinical study results information will be submitted, if the
Delay Results Type is "Extension".
Explanation [*] (Required when Delay Results Type is "Extension.")
Definition: Description of the reason(s) why clinical study results information cannot be provided
according to the deadline, with sufficient detail to justify good cause for the extension and to allow for the
evaluation of the request. Note that "pending publication" and delays in data analysis for unspecified
causes are not considered good cause for an extension.
Limit: 999 characters.

1

Attachment 7

25 Oct 2022

OMB NO: 0925-0586
EXPIRATION DATE: 02/28/2023
Burden Statement
Public reporting burden for this collection of information is estimated to vary from 2.0 to 8.0
hours per response for registration, 10.0 to 45.0 hours per response for results information
submissions, and 15 minutes to 2 hours for other submissions including certifications for delay,
extension requests, and expanded access. These estimates include the time for reviewing
instructions, searching existing data sources, gathering the data needed, and completing and
reviewing the collection of information. An agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it displays a currently valid OMB
control number. Send comments regarding this burden estimate or any other aspect of this
collection of information, including suggestions for reducing this burden, to: NIH, Project
Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA
(0925-0586). Do not return the completed form to this address

2

Attachment 7

25 Oct 2022

3