Page 291 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

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. RegisteringExpandedAccessRecords
O. How to Register an Applicable Clinical Trial?
P. RequiredRegistrationUpdate
Q. EditingClinicalTrials.GovStudyRecord
R. SubmissionofResults
S. AdverseEventReporting
T. UpdatesandOtherRequiredInformation
10. PROCESS MAP
11. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q021
04/01/2021
Updated FAQs, definitions and QRG
24
SOP No. 24, 07-14-2020