Page 334 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
record, including its NCT Number, will be available on ClinicalTrials.gov within 2–5 business days.
M. RequiredRegistrationUpdate
Responsible Parties should update their records within 30 days of a change to any of the following:
− Individual Site Status and Overall Recruitment Status data elements on ClinicalTrials.gov
− Primary Completion Date data element on ClinicalTrials.gov on ClinicalTrials.gov.
As described in 42 CFR Part 11, additional information must also be updated within
15 or 30 days of a change. Other changes or updates to the record must be made at
least every 12 months. It is recommended that the Record Verification Date be
updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record.
N. Editing ClinicalTrials.Gov Study Record
At any time, Responsible Parties can make updates and edits to a record published on ClinicalTrials.gov by logging into the Login to ClinicalTrials.gov PRS and clicking
on Edit Record under the Protocol Records heading on the PRS main menu. After
making changes, Responsible Parties will need to release (submit) the record to ClinicalTrials.gov for review and processing. See the ClinicalTrials.gov Protocol
Review Criteria (PDF) for a description of items that should be addressed before
releasing the record to ClinicalTrials.gov. See the ClinicalTrials.gov Protocol Information Review Process for more information.
O. Submission of Results
This final rule addresses the statutory requirement for the submission of summary results information for applicable clinical trials of drug products (including biological products) and device products that are approved, licensed, or cleared by FDA. It also
extends the requirement for results information submission to applicable clinical trials of drug products (including biological products) and device products that are not approved, licensed, or cleared by FDA. The rule requires the submission of data in a tabular format summarizing participant flow; demographic and baseline characteristics; primary and secondary outcomes, as well as results of any
scientifically appropriate statistical tests; and adverse event information. In addition, the rule requires the submission of the full protocol and statistical analysis plan (if a separate document).
In general, this rule requires the submission of results information not later than 1 year after the completion date (referred to as the “primary completion date”) of the clinical trial, which is defined as the date of final data collection for the primary outcome measure. Results information submission could be delayed for up to 2
additional years from the date of submission of a certification that either an unapproved, unlicensed, or uncleared product studied in the trial is still under development by the manufacturer or that approval will be sought within 1 year after