ACRP Webinar

“Building a Successful Patient Recruitment Plan & Budget”
Date: Wednesday, February 15, 2016
Time: 11:00 AM – 12:00 PM CST
Location: College of Public Health Room 3/202

The Translation Research Institute (TRI) will be presenting Building a Successful Patient Recruitment Plan & Budget , a one-hour webinar hosted by the Association for Clinical Research Professionals (ACRP). The speaker of the hour is Chris Trizna, President of CSSi, the only company in the global patient recruitment sector whose focus is on increasing site performance and optimizing patient enrollment.

During this workshop the audience will learn how to efficiently plan and budget for successful patient recruitment. Targeting the correct audience is a key component of the recruitment process, and we will explore the steps on how to effectively develop a marketing strategy to do so. Understanding how to best research, identify and reach your patients through a multi-platform strategy can help expedite the recruitment process.

Upon completion of this Webinar, attendees should be able to:

  • Explore the necessary steps for building an effective patient recruitment plan
  • Learn how to successfully develop an advertising strategy using traditional, online, and social recruitment tools
  • Understand the pros and cons of using traditional advertising vs social media, and the most effective ways for setting up each technique
  • Adopt Best Practices in Patient Recruitment

1 CRS credit hour

Click here to register via Training Tracker

Barnett International Web Training

“Adverse Event Monitoring for CRAs”
Date: Thursday, February 16, 2017
Time: 11:00 AM – 12:30 PM CST
Location: Education II Building G104A/B

During monitoring visits, one of the most important and impacting activities that a Clinical Research Associate (CRA) performs is the source document verification of Adverse Events (AEs). The CRA serves as the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of AEs can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post-marketing labeling. The safety, regulatory, and ICH definitions will be reviewed and applied to the monitoring process in this web seminar. This includes Causality, Expectedness/Unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning.

Learning Objectives:

  • Define safety concepts and reporting requirements
  • Recognize the importance of verifying the subject baseline history
  • Determine when to start and stop monitoring AEs
  • Apply a detailed presentation of the source document verification process of AEs
  • Manage challenges in monitoring AEs
  • Verify appropriate credentialing for site AE evaluation of event relationship
  • Appreciate the impact of monitoring on future product labeling
  • Discuss reporting trends

Who Should Attend:

  • Device and Drug Study Clinical Research Associates
  • Contract Clinical Research Associates
  • Clinical Research Associate Managers
  • Project Managers

1.5 CRS credit hours

Click here to register via Training Tracker

Quorum Review Webinar

“How eConsent Optimizes Research for Sponsors and CROs”
Date: Tuesday, February 21, 2017
Time: 12:00 PM – 1:00 PM CST
Location: College of Public Health Room 2/280

Electronic informed consent, or eConsent, is an exciting potential tool for clinical researchers. But why should they adopt it? Will it positively impact timelines? Will it complicate research? Discover how the right eConsent tool will pay dividends by delivering real-world efficiency and improved compliance. Plus, get tips for choosing an eConsent vendor that will help you successfully transition away from paper.

Those who attend this 60-minute webinar will:

  • Find out how to streamline study startup time with the right eConsent tool and vendor
  • Discover ways eConsent can prevent consenting errors the first time
  • Learn how the right eConsent tool directly connects to participant engagement and retention

1 CRS credit hour

Click here to register via Training Tracker

PRIM& R Webinar

“Social Media as a Research Recruitment Tool: Ethical Considerations and Guidelines for IRB”
Date: Thursday, February 23, 2017
Time: 12:00 PM – 1:30 PM CST
Location: College of Public Health Room 2/280


The use of social media as a recruitment tool for research with human subjects has shown signs of effectiveness. The use of this recruitment method is likely to increase due to social media’s convenience, affordability, and ubiquity. For example, researchers recently leveraged social media to locate individuals with a rare heart condition and meet enrollment targets in one week for a study they were conducting on the condition (Tweet et al)1. Social media has also shown effectiveness at reaching other populations that have historically been considered hard to access, such as pediatric cancer survivors (Gorman et al.)2 and gay Latino couples3. To date, however, there has been no specific regulatory guidance on social media recruitment. In order to ensure that these potentially invaluable recruitment methods are utilized in ways that safeguard the rights and interests of possible subjects and social media users, IRBs need the right tools to evaluate their ethical and regulatory acceptability.

Using case studies from biomedical and social and behavioral research, this webinar will highlight pertinent ethical and practical considerations when evaluating the use of social media to recruit study subjects. Topics for discussion will include:

  • Federal regulations pertaining to subject recruitment and their applicability to social media contexts
  • Methods, tools, and processes for use by investigators and IRBs when developing social media recruitment techniques and evaluating them from an ethical perspective
  • Key ethical principles of subject privacy and investigator transparency
  • Novel ethical aspects of social media recruitment, including compliance with website “terms of use,” recruiting from online networks of research subjects, and ethical implications of online communication from and among study subjects

What will I learn?
After attending this webinar, attendees will be able to:

  • Apply relevant federal regulations to the context of social media recruitment
  • Utilize the appropriate methodology for assessing social media recruitment techniques when reviewing protocols
  • Understand the norms of respect for privacy and investigator transparency, as well as potentially unfamiliar ethical aspects of social media recruitment techniques that may apply in the social media context

Who should attend?
This intermediate-level webinar will benefit IRB staff and members, compliance personnel, institutional officials, researchers, and research staff who work in either biomedical or social and behavioral research that uses social media for study recruitment.

1.5 CRS credit hours

Click here to register via Training Tracker

Barnett International Web Training (Host)

“Writing Clinical Study Protocols”
Date: Monday, March 6, 2017
Time: 10:00 AM – 12:30 PM CST
Location: College of Public Health 3/202

The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and market approval.

Over the course of a development plan, new protocols, amendments, and concept sheets will be needed. Protocols for Phases 1, 2, 3 and 4 require different writing approaches and you must know what the agency expects at every development milestone to avoid the trial being put on clinical hold. Moreover, amendments, however unwelcome, are a necessary part of the development process.

Learning Objectives

  • Describe the overall structure of a protocol and regulatory requirements
  • Describe the requirements for a protocol, including:
  • Establishing the indication(s)
  • Types of studies
  • Design (single blind, double blind, randomized, etc.)
  • Establishing the hypothesis
  • What is safety and efficacy and how do you establish either or both
  • Determining inclusion/exclusion criteria
  • Determining the Schedule of Events
  • Adverse and Serious Adverse Event reporting

Who Should Attend   

  • Medical Directors
  • Medical Writers
  • Clinical Research Associates
  • Regulatory Affairs Professionals
  • Research and Development Personnel

2.5 CRS credit hours

Click here to register via Training Tracker