Page 322 - 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
managed by a not-for-profit organization, have a mechanism to ensure the validity of the registration data, and are electronically searchable.
Links
Updates and Editorials - http://www.icmje.org/news-and-editorials/
Frequently Asked Questions - http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/ ICMJE Guidance - http://www.icmje.org/journals-following-the-icmje-recommendations/
6. KEY CLINICAL TRIAL REPORTING REQUIREMENTS
Reporting Requirements
ICMJE Policy (Effective in 2005)
FDAA Final Rule (Issued in 2016)
Final NIH Policy (Issued in 2016)
Scope
Registration
Registration & Results Reporting
Registration & Results Reporting
Phase
All
Not Phase I
All
Intervention Type
All
Drug, Biologics, & Device Products regulated by the FDA
All (r.g., including behavioral interventions)
Funding Source
Any
Any
NIH
Enforcement
Refual to Publish
Criminal proceedings and civial penalties (up to $10,000/day); loss of HHS funding
Loss of NIH funding
7. SCOPE
This SOP applies to all clinical trials that are being conducted at Children’s Health – regardless of funding source – where the Principle Investigator (PI) is a Children’s Health Employee.
8. RESPONSIBILITIES
Researcher Administration Responsibilities
Creation of PRS Account for Children’s Health with ClinicalTrials.Gov
1. The Director of Research Administration (or a designee) will assist with requesting ClinicalTrials.Gov with a Protocol Registration and Results System (PRS) for the purpose of ClinicalTrials.Gov registration for applicable clinical trials (ACT). Steps as outlined in “Frequently Asked Questions” section, Question C, will be followed to create PRS account for Children’s Health. A general e-mail address account titled
SOP No. 24, 07-14-2020, 05-31-2022