Page 316 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
1. ACRONYMS
Research Administration SOP No: Q021
SOP Title: FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
ACT – Applicable Clinical Trial
FDA - Food and Drug Administration, HHS
FDAAA - Food and Drug Administration Amendments Act of 2007 HHS - Department of Health and Human Services
ICMJE - International Committee of Medical Journal Editors
IDE – Investigational Device Exemption
IND – Investigation New Drug application
NCT – National Clinical Trial
NIH - National Institutes of Health, HHS
2. DEFINITIONS
See Definitions Document for more information
A. ClinicalTrial
B. Applicable Clinical Trial
C. Applicable Device Clinical Trial
D. Applicable Drug Clinical Trial
E. Responsible Party
F. Sponsor
G. Sponsor Investigator
H. PrincipalInvestigator
I. Study Start Date
J. Enroll or Enrolled
K. PrimaryCompletionDate
3. SUMMARY
Based on requirements set in Section 801 of the Food and Drug Administration Amendments Act of 2007, known as FDAAA 801, The ClinicalTrials.gov Protocol Registration and Results System (PRS) was established as a web-based tool used to submit applicable clinical study information to ClinicalTrials.gov. Records submitted through the PRS are available to the public at ClinicalTrials.gov.
Title VIII of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA) expanded the legal mandate for sponsors and others responsible for certain clinical trials of FDA-regulated drug, biologic, and device products to register their studies and report summary results information to ClinicalTrials.gov, which is managed by the National Library of Medicine at the National Institutes of Health (NIH). The statute expanded registration requirements and provided a legally defined timeline with specific requirements for the systematic reporting of summary trial results. Although statutory components took effect before 2010, the FDAAA directed the Department of Health and
SOP No. 24, 07-14-2020, 05-31-2022