Form 3 Certification to Delay Submission of Results Information

Attachment 6

21 Dec 2016

Attachment 6 - Certification to Delay Submission of Results Information (DRAFT)

A. From ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational
Studies (DRAFT), January 18, 2017:

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. 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
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Certify Initial Approval: Trial studies an FDA-regulated drug product (including a
biological product) or device product that was not approved, licensed or cleared by FDA
for any use before the Primary Completion Date of the trial, and the sponsor intends to
continue with product development and is either seeking, or may at a future date seek,
FDA approval, licensure, or clearance of the drug product (including a biological
product) or device product under study.
Certify New Use: Trial studies an FDA-regulated drug product (including a biological
product) or device product that previously has been approved, licensed, or cleared, for
which the manufacturer is the sponsor of the trial and for which an application or
premarket notification seeking approval, licensure, or clearance of the use being studied
(which is not included in the labeling of the approved, licensed, or cleared drug, product
(including a biologic product) or device product) has been filed or will be filed within
one year with FDA.
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)]
Intervention Name(s)
Definition: Provide the name of one or more drugs, biological products or devices to which the
certification applies. For drugs use generic name; for other types of interventions provide a brief

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descriptive name. The name(s) entered should match Intervention Name(s) provided in the
protocol section.
FDA Application Number(s)
Definition: Provide at least one FDA application number (for example, NDA, BLA, or PMA
number), if available, when Delay Results Type is "Certify Initial Approval" or "Certify New
Use."
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.

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B. From the PRS Test System:

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