Page 325 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
Research Administration SOP No: Q021
SOP Title: FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
G. What is a clinical trial?
H. What is an applicable clinical trial (ACT)?
I. What is the definition of a drug, biological, or device product under
investigation being "manufactured" in the United States?
J. Which trials need to be registered and results reported in
ClinicalTrials.Gov?
K. Whenmusttrialsberegistered?
L. When must results be submitted?
M. Registering Observational Studies
N. Registering Expanded Access Records
O. How to Register an Applicable Clinical Trial?
P. Required Registration Update
Q. Editing ClinicalTrials.Gov Study Record
R. SubmissionofResults
S. Adverse Event Reporting
T. Updates and Other Required Information
10. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q021
08/01/2022
• Removal of Victoria Brown
Q021
SOP No. 24, 07-14-2020, 05-31-2022