1. ClinicalTrials.gov: An introduction
Presented by: Tracy Gatlin, B.S., CT.gov Administrator
Date: September 20, 2017

2. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
Terms to know:
ACT-Applicable Clinical Trial.
ICMJE-International Committee of Medical Journal Editors.
CMS-Center for Medicare and Medicaid Services
NIH-National Institute of Health.
FDAMA-Food and Drug Administration Modernization Act of 1997
FDAAA-Food and Drug Administration Amendments Act of 2007 2

3. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
CT.gov: Historical Timeline
1997: Congress Passes Law (FDAMA) Requiring Trial Registration
2000: NIH Releases ClinicalTrials.gov Web Site
2005: International Committee of Medical Journal Editors Requires Trial Registration
2006: World Health Organization Establishes Trial Registration Policy
2007: Congress Passes Law (FDAAA) Expanding ClinicalTrials.gov Submission Requirements
2015: CMS requires NCT # for all billable research claims
2016: Final Rule for FDAAA 801 Issued
2016: Final NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information Issued 3

4. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
Why do I have to register?
It is the law.
Your ability to publish could be affected.
Your funding as an investigator and for the institution could be affected.
Civil monetary penalties up to $11, for all violations in a single proceeding.
$11,569.00/day after 30 day period that the violation is uncorrected.
HHS may withhold remaining or future grants
NIH may post notices of non-compliance and issue penalties. 4

5. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
Agencies Requiring Registration:
FDA/NIH-Applicable Clinical Trials (ACTs)
NIH-2016 Policy
ICMJE-Publication
CMS-Billing Medicaid
Note: All 4 agencies have the ability to affect funding and publication for noncompliance. 5

6. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
Determining A Trial For Registration:
CLARA submission
Is the study investigator initiated vs industry or cooperative group?
What is the study phase?
Is UAMS the main site?
What is the funding source?
Would this be an ACT?
Is the study already registered? 6

7. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
Determining A Trial For Registration (Cont):
Determination is made
Not Applicable
Required under the law
Required under NIH policy
Not required but recommended for publication purposes (ICMJE)
Pending review of other committees
Investigator receives notification thru the CLARA system once a final determination has been made. 7

8. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
CT.gov Database Modules:
Protocol Section
Study Status
Oversight
Study Description
Study Design
Outcome Measures
Results
Participant Flow
Baseline Characteristics
Outcome Measures and Statistical Analysis
Adverse Events 8

9. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
Investigator Responsibilities:
Contact Administrator if assistance is needed:
New User Account
CT.gov Training
Register study prior to the first subject being enrolled, unless request placed for Administrator help with registration.
Keep study updated a minimum of every six months or as requested by the Administrator
Enter in results within one year of the Primary Completion Date 9

10. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
CT.gov Administrator Responsibility:
Make determination for registration requirements in CLARA and notify the PI.
Assign new user accounts
Assist PI as requested
Send reminders via /telephone
Review and release studies. 10

11. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
Is my study an Applicable Clinical Trial?
Generally:
Study type: Interventional
Study Phase/Primary Purpose: Other than Phase 1/other than feasibility
Studies a U.S. FDA-regulated drug/device product
One or more of the following
At least one facility location with the U.S./U.S. territory
Clinical trial has an IND or IDE
A drug/device produyct under investigation is a product manufactured and exported from the U.S 11

12. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
Is my study a clinical trial under the NIH policy?
Does the study involve human participants?
Are the participants prospectively assigned to an intervention?
Is the study designed to evaluate the effect of the intervention on the participants?
Is the effect being evaluated a health-related biomedical or behavioral outcome?
If the answer to ALL 4 questions is yes then the study would be considered a clinical trial according to the NIH definition. 12

13. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
ClinicalTrials.gov: What’s New?
Individual Participant Sharing Statement
Plan to Share Data and Plan Description have been added to the Protocol Section.
This section is optional under the law but is required under ICMJE
Documents Section
Allows for upload of study documents into CT.gov.
The study protocol and the Statistical Analysis Plan are required to be uploaded as part of the results information submission for all studies labeled as ACTs or that fall under the NIH policy with a Primary Completion Date on or after January 18, 2017.
Study documents must be in PDF/A format. 13

14. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
ORRA CT.gov Available Services:
Review for possible registration
Individual trial registration
Assistance with CT.gov conference call
Trial maintenance assistance
Contact Tracy at for assistance 14

15. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
Tips!
Know your study
Acronyms and misspellings
Outcome measures
Primary outcome must be specific and measurable
Primary outcome must be one thing
Use the Description fields for detail, leave detail out everywhere else
No verbs and pronouns
Make it easy on yourself and copy/paste where you can
Ask for help. 15

16. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
Resources:
Information on registering clinical trials:
Revised FAQ section
The International Committee of Medical Journal Editors policy on trial registration:
NIH Policy on the Dissemination of Clinical Trial Information 16

17. ORRA Tracy L. Gatlin, B.S. UAMS ClinicalTrials.gov Administrator
Contact Information:
Tracy Gatlin, UAMS ClinicalTrials.gov Administrator
Office of Research Regulatory Support, Slot 813
Phone: 17