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PLEASE DO NOT MESSAGE ME IF YOU DON'T KNOW ANYTHING ABOUT HTML5 CODING OR BUILDING A WEBSITE.. THIS IS NOT A PAPER!!!!!!!

my website is about learning clinicaltrials.gov.  I have started on the paper part but there are some things that need to be completed. 

 

Overview of Project

Audience and Purpose (suggested completion date: end of week 3)

As you are introduced to your final project, you should begin envisioning your target audience and educational purpose for your website, using that information to consider the best layout for the site. For your final project, you should write a description of your educational purpose (at least 150 words) and target audience (at least 200 words). Read pages 204-205 in the Felke-Morris text for a brief introduction to designing for an audience.

Design (suggested completion date: end of week 3)

When planning for your website, it is important that you begin considering the visual design of your site. While we will discuss this in much more depth in EDTC 5555, you should begin initial planning now. As part of your final project, you should include two elements of design:

  1. Explanation of how you’ll create a unified structure and style – This should be at least 100 words, with specific techniques. Consider the guidelines in Felke-Morris chapter 5.
  2. Projected Color Scheme – 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).

Site Map (suggested completion date: end of week 5)

A site map provides a diagram of the organization of your website. Sitemaps can be created with any diagramming tool, including Microsoft Word. Before you begin designing your sitemap and wireframes, it's important to consider your site's purpose, audience, and the navigation structure that would be most appropriate to both. Read pages 205-206 in the Felke-Morris text for a review different approaches to organization, including hierarchical, linear, and random. The minimum number of pages in your final site should be:  a home page, and 5-6 other pages, linked together somehow.

Wireframes (suggested completion date: two at end of week 5, the rest by end of week 7)

Wireframes offer an actual physical mock-up of the pages in your website. Read pages 225-226 in the Felke-Morris text for an overview of wireframes. Wireframes could be created in anything, including Word. There are also some tools available online to help you create them: http://www.creativebloq.com/wireframes/top-wireframing-tools-1112130 (Links to an external site.) . Just be sure that, whichever tool you use, you could export all content to one document for your final project. For a specific overview of the design and purpose of wireframes, view the following video:
http://youtu.be/vXLDqaH9vkE (Links to an external site.)

The details for EACH page on the wireframes should include such things as:

  • the text you’ll include
  • any images
  • the navigation links on each page
  • any html elements (e.g. using tables to layout the page, using an ordered list etc.)

When you actually create this site by coding it next term in EDTC 5555, you will be asked to include certain elements. If you'd like to include them in your planning at this point, they are listed below; however, it is not required that you have all of these elements at this point. You are only required to have the elements included in the checklist below.

The required HTML elements next term will be:

  • A navigation bar on each page that allows me to get to all pages. This could be in the form of a list of links at the top or left of the page, buttons, etc.
  • Tables (at least two)
  • Graphics, appropriate for education and consistent throughout site (at least three)
  • Hyperlinks to appropriate educational web sites AND to other file formats, such as Word documents, PowerPoint Presentations, PDFs, etc. (at least twelve total, four to other web sites, four to other files, and four of your choice)
  • Lists – ordered, unordered, description (at least two of the three)
  • Date last updated (on the main page)
  • Comments, using comment tag (on each page, giving at least your name and date created)
  • Forms, including at least four different elements (at least two forms)
  • Style sheet (at least one external style sheet, formatting a few required elements)
  • An interactive, web 2.0 element (we will cover more of what this means in the second term)

Completion and Submission

Checklist of Requirements

  • an explanation of the EDUCATIONAL purpose of your site (at least 150 words)
  • an explanation of the target audience of your site (at least 200 words) 
  • a visual organization (site map) of your site (Example:  Felke-Morris, pgs 205-206)
  • an explanation of how you will create a unified structure and style for the site as a whole (at least 100 words, with specific techniques)
  • an overview of your color scheme for your site, including:
    • the type of color scheme
    • visual samples
    • hexadecimal codes
  • wireframes from each of six pages in your web site, including the elements you would include on each of those pages  (Example:  Felke-Morris, pgs 225-226).  The total number of pages should be:  a home page, and 5-6 other pages, linked together somehow
  • details for EACH page on the wireframes should include such things as:
    • the text you’ll include
    • any images
    • the navigation links on each page
    • any html elements (e.g. using tables to layout the page, using an ordered list etc.)

Submission

  • The project should be submitted as ONE document, in PDF format. Use any necessary tools to merge files of different formats into one document.
  • Upload your final project document to the drop box on WorldClassRoom by the end of week seven.

Gibbs 1

EDTC 5550 Final Project

Tawana Gibbs

Mrs. Angela Astuto

EDTC 5550

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)

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

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.)

https://lh4.googleusercontent.com/wr5_ZMT428aeDbhKIsdoM7sS0raz6BJToIVA8NdXv0OagtuUbz2tUq-D4PLUIJs_l2sHG4kayCU8MX03WA5p7xfIVIlhrrNdBfOQBbjdR2MoBZCCrMOdXtQ0mY7uXSPMjGwuF094

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

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ClinicalTrials.gov: An Introduction

Presented by: Tawana Gibbs, MA, CRS

CT.gov Administrator

Date: February 20, 2019

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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

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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.

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https://clinicaltrials.gov/ct2/about-site/background#WhatIsClinicalTrials

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  • 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
  • 2017: Final rule implementing major revisions to the Common Rule

https://clinicaltrials.gov/ct2/about-site/history

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CT.gov: Historical Timeline

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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

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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.

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Agencies that Require Registration

  • FDA
  • NIH
  • ICMJE
  • CMS

Note: All 4 agencies have the ability to affect funding and publication for noncompliance.

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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

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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 product under investigation is a product manufactured and exported from the U.S

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https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf

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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?

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.

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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.

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Study is an Applicable Clinical Trial

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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

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

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FYI: The CT.gov administrator is notified when changes have been made to the record

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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

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Tips on ClinicalTrials.gov

  • Know your study
  • Acronyms and misspellings
  • Outcome measures

Primary outcome must be single, specific, and have a measurable outcome

  • Use the modules for detail, leave detail out everywhere else
  • No verbs and pronouns
  • Make it easy on yourself copy/paste where you can
  • Ask for help!

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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

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Contact Information

Tawana Gibbs,

UAMS ClinicalTrials.gov Administrator

Office of Research Regulatory Affairs

Slot 813

Phone: 501-686-5190

Email: [email protected]

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