ClinicalTrials.gov: An Introduction Presented by: Tawana Gibbs, MA, CRS CT.gov Administrator Date: February 20, 2019 * Important 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 HHS- Department of Health and Human Services FDA- Food and Drug Administration NCT- National Clinical Trial * * What is ClinicalTrials.gov? Web-based resource that provides patients, their family members, healthcare professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. * https://clinicaltrials.gov/ct2/about-site/background#WhatIsClinicalTrials * 1997: Congress Passes Law (FDAMA) Requiring Trial Registration2000: 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 Requirements2015: CMS requires NCT # for all billable research claims2016: Final Rule for FDAAA 801 Issued2016: Final NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information Issued2017: Final rule implementing major revisions to the Common Rule https://clinicaltrials.gov/ct2/about-site/history * CT.gov: Historical Timeline * Registry and Results Database Purpose Registry purpose: Fulfill ethical obligations to participants and the research community Provide information to potential participants and referring clinicians Reduce publication bias Help editors and others understand the context of study result Promote more efficient allocation of research funds Helps institutional review boards (IRBs) determine the appropriateness of a research study Results Database Purpose: Provide a public record of basic study results in a standardized format Promote the fulfillment of ethical obligations to participants and the overall contribution of research results to medical knowledge Reduce publication and outcome reporting biases Facilitate systematic reviews and other analyses of the research literature * * Why Registration is Required 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 $10,000 for all violations in a single proceeding. $10,000/day after 30 day period that the violation is uncorrected. HHS may withhold remaining or future grants funds NIH may post public notices of non-compliance and issue penalties. * * Agencies that Require Registration FDANIHICMJECMS Note: All 4 agencies have the ability to affect funding a ...

1. ClinicalTrials.gov: An Introduction
Presented by: Tawana Gibbs, MA, CRS
CT.gov Administrator
Date: February 20, 2019
*
Important 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
HHS- Department of Health and Human Services
FDA- Food and Drug Administration
NCT- National Clinical Trial
*
*

2. What is ClinicalTrials.gov?
Web-based resource that provides patients, their family
members, healthcare professionals, researchers, and the public
with easy access to information on publicly and privately
supported clinical studies on a wide range of diseases and
conditions.
*
https://clinicaltrials.gov/ct2/about-
site/background#WhatIsClinicalTrials
*
1997: Congress Passes Law (FDAMA) Requiring Trial
Registration2000: 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
Requirements2015: CMS requires NCT # for all billable
research claims2016: Final Rule for FDAAA 801 Issued2016:
Final NIH Policy on the Dissemination of NIH-Funded Clinical
Trial Information Issued2017: Final rule implementing major
revisions to the Common Rule
https://clinicaltrials.gov/ct2/about-site/history
*
CT.gov: Historical Timeline
*
Registry and Results Database Purpose
Registry purpose:

3. Fulfill ethical obligations to participants and the research
community
Provide information to potential participants and referring
clinicians
Reduce publication bias
Help editors and others understand the context of study result
Promote more efficient allocation of research funds
Helps institutional review boards (IRBs) determine the
appropriateness of a research study
Results Database Purpose:
Provide a public record of basic study results in a standardized
format
Promote the fulfillment of ethical obligations to participants
and the overall contribution of research results to medical
knowledge
Reduce publication and outcome reporting biases
Facilitate systematic reviews and other analyses of the research
literature
*
*

4. Why Registration is Required
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 $10,000 for all violations in a
single proceeding.
$10,000/day after 30 day period that the violation is
uncorrected.
HHS may withhold remaining or future grants funds
NIH may post public notices of non-compliance and issue
penalties.
*
*
Agencies that Require Registration
FDANIHICMJECMS
Note: All 4 agencies have the ability to affect funding and
publication for noncompliance.
*
*
ClinicalTrials.gov Registration Timeframe for Agencies
FDA/NIH- study is required to be registered no later than 21
days after 1st subject is enrolled
CMS/ICMJE- study must be registered prior to first subject
being enrolled
*
*

5. Is My Study an Applicable Clinical Trial
Generally:Study type: InterventionalStudy Phase/Primary
Purpose: Other than Phase 1/other than feasibilityStudies a
U.S. FDA-regulated drug/device productOne or more of the
followingAt least one facility location with the U.S./U.S.
territoryClinical trial has an IND or IDEA drug/device product
under investigation is a product manufactured and exported
from the U.S
*
https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
*
*
Decision Tree for NIH Clinical Trial Definition
NO
YES
NO
NO
NO
YES
YES
YES
Does the study involve human participant research?
Are participants prospectively assigned to an intervention?

6. 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?
This study is a clinical trial.
The study is NOT a clinical trial.
*
If UAMS is Lead site:
Clinical Trials.gov administrator in ORRA will notate
determination in CLARA
Notify PI of the determination and create new record once IRB
approval is obtained.
Administrator will work with PI to have record approved by
CT.gov, who will then provide the NCT number.
*
Study is an Applicable Clinical Trial
*
CT.gov Administrator and
PI Responsibilities
CT.gov Administrator Responsibilities:
Review for possible registration
Create and maintain Ct.gov record
Provide a notification for Ct.gov update to PI, as needed
Assistance with CT.gov conference call

7. Principal Investigator Responsibilities:
Input all clinical trial information in appropriate section of
modules
Update information when changes have been made or at the
request of the administrator
*
FYI: The CT.gov administrator is notified when changes have
been made to the record
*
*
CT.gov Database ModulesProtocol Section
Study Status
Oversight
Study Description
Study Design
Outcome MeasuresResults
Participant Flow
Baseline Characteristics
Outcome Measures and Statistical Analysis
Adverse Events
*
*
Tips on ClinicalTrials.gov
Know your studyAcronyms and misspellingsOutcome measures

8. Primary outcome must be single, specific, and have a
measurable outcomeUse the modules for detail, leave detail out
everywhere elseNo verbs and pronounsMake it easy on yourself
copy/paste where you canAsk for help!
*
*
*
*
What’s New: Clinical trials.gov
https://clinicaltrials.gov/ct2/about-site/new
INFORMATION ON REGISTERING CLINICAL TRIALS:
http://prsinfo.clinicaltrials.gov
Revised FAQ section
https://clinicaltrials.gov/ct2/manage-recs/faq#act
The International Committee of Medical Journal Editors policy
on trial registration:
http://www.icmje.org/clin_trialup.htm
NIH Policy on the Dissemination of Clinical Trial Information
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-
149.html
History of Clinicaltrials.
https://clinicaltrials.gov/ct2/about-site/history
Source: Zarin DA, Keselman A. Registering a clinical trial in
ClinicalTrials.gov. Chest. 2007;131(3):909-12. [Full Text]
Source: Tse T, Williams RJ, Zarin DA. Reporting "basic
results" in ClinicalTrials.gov. Chest. 2009;136(1):295-303.
[Full Text]
RESOURCES

9. *
*
Contact Information
Tawana Gibbs,
UAMS ClinicalTrials.gov Administrator
Office of Research Regulatory Affairs
Slot 813
Phone: 501-686-5190
Email: [email protected]
*
Gibbs 1
EDTC 5550 Final Project
Tawana Gibbs
Mrs. Angela Astuto
EDTC 5550

10. 12 October 2019
Educational Purpose
When research first began, there wasn’t a way to track all the
clinical trials, so over the years there were laws developed in
order to put this database in place. The database was created in
order to be able to keep track of all the trials and to provide the
public with access. The educational purpose of this training is
to inform new Private investigators and their staff on the
importance of registering their clinical trials with
Clinicaltrials.gov. This class will provide you with resources
on the historical information of Clinicaltrials.gov, it will
provide information on how to determine if the clinical trial
needs to be registered, why it needs to be registered, how to
register the trial in Clinicaltrials.gov, and how to enter results
in to Clinicaltrials.gov. Please feel free to click on the links
that will take you to learning some of the background
information of Clinicaltrials.gov, because this training class is a
3 day course.
Target Audience
At the University of Arkansas for Medical Sciences, it is
important that the new research professionals that are being
hired understand the purpose for registering the clinical trials
into Clinicaltrials.gov. The research professionals include
Private Investigators, Sub- Private Investigators, Clinical
Researchers, the Research support staff, and Regulatory Affairs
specialist. The individuals that were named above tend to
maintain the clinical trials information for their study, so it is
extremely important that they understand what is expected of
them when maintaining the site
Site Map (needs to be completed)

11. Creating a Unified Structure and Style
Each page will consist of UAMS Clinicalstrials.gov heading in
the upper right-hand corner in red and the background color will
be gray. On the home page, it will consist of a research
photograph as the banner, giving a brief introduction of what
the website contains. The font size will be
f at least 100 words explaining how you will give your site a
unified structure and style. Be specific about the techniques
you’ll use (e.g. navigation bar on each page, same colors for all
H1 headings, etc). Review chapter 5 in the Felke-Morris text for
some ideas.
Color Scheme( needs to be completed)
In this space, indicate the type of color scheme (e.g.
complementary, triadic, etc.). Include visual samples of all
major colors your plan to use, along with their hexadecimal
code. Read pages 213-218 of the Felke-Morris text and Chapter
7 in the Williams text for guidelines on color. Your visual
samples could look similar to what is given at the top of page
214 of the Felke-Morris text (including hexadecimal codes).
See below for a sample of what you might include. (Note that
this is a sample only, and not necessarily attractive choices for
a website.)
Complementary Monochromatic Color Scheme
Background Color:
Headings:
Body Text:
Link Text:
Hexadecimal Code:
#B3B3B3

12. Hexadecimal Code:
#210E5B
Hexadecimal Code:
#301D68
Hexadecimal Code:
#846f06
Wireframes (for at least 6 pages total)(needs to be completed)
This section should include wireframe sketches for at least six
pages total. (See samples below for examples– these are small
versions; yours should be much larger, nearly filling the page.)
Home page
What is Clinicaltrials.gov
How to Register Trial in Clinical Trials.gov
Entering results
Resource Links
Contact Page
Questions on how to make the determination