Page 333 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
• FDA: Expanded Access (Compassionate Use)
• FDA: For Patients - Learn About Expanded Access and Other Treatment Options
• FDA: Expanded Access for Medical Devices
L. How to Register an Applicable Clinical Trial?
1. Determine who is responsible for registering the clinical study and which Protocol Registration and Results System (PRS) account should be used.
2. ClinicalTrials.gov allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to:
− Any applicable human subject or ethics review regulations (or equivalent)
− Any applicable regulations of the national or regional health authority (or equivalent)
3. Completion of “Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) Under 42 CFR 11.22(b) for Clinical Trials Initiated on or After January 18, 2017” is required for each study under review for ClinicalTrials.gov registration.
4. Login to PRS
5. Enter the required and optional data elements
For basic help with using PRS, review the Quick Start Guide found in the Help section of the PRS main menu. More detailed instructions are available in the PRS User's Guide, also found on the PRS main menu.
6. Preview, inspect, and release (submit) the record
7. See the ClinicalTrials.gov Protocol Review Criteria (PDF – in resources
folder) for a description of items that should be addressed before releasing the record to ClinicalTrials.gov.
ClinicalTrials.gov Protocol Review Criteria Document is available in Resources Folder
8. Verify in PRS that the Record Status is released. The record will not be processed by ClinicalTrials.gov unless it is released. Only the Responsible Party or a PRS account administrator can release the record.
9. A ClinicalTrials.gov staff member will review the study record after it is released (submitted) and before it is published on ClinicalTrials.gov. This review will focus on apparent validity (when possible), meaningful entries, logic and internal consistency, and formatting. PRS administrator may be asked to clarify items or make corrections to the record before publication. Please note that the review process may take up to a few days. Ensuring that the record is consistent with the ClinicalTrials.gov Protocol Revie w Criteria (PDF) before releasing it will expedite publication on the site. The