1. ClinicalTrials.gov Protocol Registration and Results System (PRS) for Research Coordinators
IRB Compliance Program
PRS Administrator, Brian Brotzman
Human Subjects Office/Institutional Review Board

2. Overview Purpose Rules and Regulations PRS and IRB Registration
Creating a Record
Record Owner vs Responsible Party
Record Owner Responsibilities
Questions

3. Purpose

4. IT’S THE LAW!! Rules and Regulations
FDAMA - Food and Drug Administration Modernization Act of 1997
FDAAA Section 801 – Food and Drug Administration Amendment Act of 2007
Final Rule (2017)
IT’S THE LAW!!
Penalties –
Fines of up to $11,383/day
Withholding of funding to the PI and the institution
Potential criminal penalties

5. Protocol Registration and Results System (PRS) and IRB
register.clinicaltrails.gov
Online system for entering data to be published on the public site
PRS training
IRB reviews PRS records and considers them in its approval
hso.research.uiowa.edu

6. Creating a Record
PRS administer to create an account
Login
Organization: uiowa
Username: hawkid
Password: you set, but PRS admin can reset, if needed
Help and User Guides
Flow – enrollment numbers and movement through study; Baseline – age and gender required, other variables desired.

7. Registration AKA ‘Protocol’ section Applicable Clinical Trial (ACT)
Unique Protocol ID = HawkIRB ID
Responsible Party = Sponsor-investigator
Interventional vs. Observational
Oversight: What is and is not an FDA regulated intervention?
University of Iowa IRB 01,
Outcome measures
Study ID – IRB#; Status – anticipated or actual; sponsor – S-I and name PI; Description – brief vs detailed; Conditions – what is being studied; Design – Interventional vs observational, phase designation; Arms – transfers to results so be sure accurate; contacts – your info.

8. Outcome Measure Example 1

9. Outcome Measure Example 2

10. Record Owner vs Responsible Party
Record Owner – Person responsible for entering data in record
Not legally responsible for record or content, but accountable for the data being entered
Responsible Party – Sponsor initiating the clinical trial and responsible for the contents of the ClinicalTrials.gov record
Is required by law to create, maintain, and monitor from beginning to end
Significant penalties if found in non-compliance
Access List

11. Record Owner Responsibilities
Assure institutional policy is adhered to
Assure information is entered accurately and consistently
Assure HawkIRB and ClinicalTrials.gov records compliment each other

12. Institutional Policies To Remember
The ‘Unique Protocol ID’ must list the HawkIRB number (digits only)
The Sponsor/Collaborators section must list ‘Sponsor-Investigator’ as the responsible party type, and the PI’s name should be selected from the drop down menu
Contacts should list research investigators, not IRB or administrative contacts unrelated to the trial

13. What Else Do We Need to Know
Results
Training
Departmental liaisons
hso.research.uiowa.edu

14. Questions?