UAMS.EDU

Webinars

PRIM& R Webinar

“Reducing Noncompliance while Facilitating Research: Strategies for IACUCs”
Date: Tuesday, January 24, 2017
Time: 12:00 PM – 1:30 PM CST
Location: CI Strauss-McCaskill 10th Floor Room 1017

Speakers will review basic reporting requirements for various regulatory/accreditation bodies, provide strategies for improved training and focused communication with research and animal care staff, and discuss how institutions can utilize post-approval monitoring as a strategy to reduce noncompliance.

Overview

Noncompliance in animal research is defined as any action that does not adhere to federal regulations and policy, an institutional policy, or the approved protocol. Fostering a culture of compliance is essential to ensuring animal welfare, institutional credibility, and positive working relationships between researchers and the IACUC.

Through interactive scenarios and case studies, an attending veterinarian (AV) and an IACUC training and compliance manager will discuss ways to encourage a culture of compliance at your institution without impeding research. During this intermediate-level webinar, presenters will:

  • Review basic reporting requirements for regulatory/accreditation bodies including OLAW, USDA, and AAALAC, and discuss the gray area of when and how to report a noncompliance event, considering issues such as species, funding source, and institutional assurances and/or program descriptions
  • Clarify the differences among regulatory noncompliance, noncompliance with institutional policies, and noncompliance with approved protocols, and discuss differences in causes of noncompliance (i.e. lack of training vs. disregard for established policy)
  • Discuss when to suspend an individual, an animal activity, or a protocol and who has the authority to do this
  • Consider issues related to whistleblowers
  • Provide strategies for reducing noncompliance by researchers and animal care staff, including enhanced oversight of non-centralized animal care and use areas; use of sustained release analgesia; and focused communication, training, and education
  • Discuss how partnerships with other institutional departments (such as Environmental Health and Safety), and engagement with your Institutional Official, can contribute to reducing institutional noncompliance
  • Discuss how institutions can utilize post-approval monitoring (PAM) as a strategy to reduce noncompliance by improving the communication of policies, reducing protocol drift, and establishing a rapport between researchers and the IACUC

What will I learn?

After attending this webinar, attendees will be able to:

  • Understand the potential complexities of noncompliance, and when and how to report it to the appropriate regulatory and funding agencies and to AAALAC
  • Navigate complex situations such as whistleblower reporting and suspension of research activity
  • Employ strategies for fostering a culture of compliance without impeding research, including improved communication and training with investigators and animal care staff; interdepartmental partnership; and post-approval monitoring

Who should attend?

This intermediate-level webinar will benefit IACUC staff and members; institutional officials; attending veterinarians; and investigators and research staff that work with animals.

1.5 – Hours of CRS Credit

Click here to register via Training Tracker


ACRP Webinar

“How Does the Recent ICH-GCP E6 Update Affect You”
Date: Wednesday, January 25, 2017
Time: 11:00 AM – 12:00 PM CST
Location: College of Public Health Room G226

The Office of Research Compliance will be presenting Conditions Impacting Consent for Clinical Research, a one-hour webinar hosted by the Association of Clinical Research Professionals (ACRP). The speaker of this event is Sandra “Sam” Sather, BSN, M.S.Ed, an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions.

Recently, a long awaited new revision of the ICH E6 GCP Guideline was released as a response to the increase in scale, complexity, and cost of clinical trials. This new revision focuses on updating and clarifying standards for electronic records and essential documents, and investigator and sponsor oversight. As a result, new questions arise about how to best manage the operations and strategy of a trial to ensure that human subject protections are supported, data quality and integrity is maintained, and documentation is properly managed. This session will give you an action plan for how the new guidances affect your trials.

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

  • Review the updates to the ICH E6 GCP Guideline
  • Identify how the finalized ICH guideline affects running clinical trials
  • Identify how the finalized ICH guideline affects sponsor oversight of the clinical trial

1 – Hour of CRS Credit

Click here to register via Training Tracker


PRIM& R Webinar

“PRIM&R’s Primer on the Revised Common Rule”
Date: Thursday, January 26, 2017
Time: 1:30 PM – 3:00 PM CST
Location: Education II Building Room G137

Overview

On January 19, 2017, the Office of the Federal Register published a revised Federal Policy for the Protection of Human Subjects, marking the first significant changes to the Federal Policy for the Protection of Human Subjects, or “Common Rule,” since 1991. These changes will have important and wide-reaching implications for the human subjects research enterprise. However, the Rule arrives under a cloud of uncertainty: A new presidential administration takes over the reins of the federal government on January 20, and it is unclear whether they will use available avenues to overturn the new Rule. Whether or not the new Rule survives long enough to be implemented, the issues it addresses are important to the future of the research oversight community.
Free for PRIM&R members and available at a discounted rate of $30 and $60 for individual and group nonmembers, respectively, this webinar will provide an overview of the critical changes presented in the Rule as well as an explanation of the rulemaking process and the various possible outcomes.

Attendees will have the opportunity to participate in a virtual Q&A session with the presenters at the conclusion of the webinar, and all registrants will receive a recording of the webinar within one week of the broadcast.

What will I learn?

After attending this webinar, attendees will:

– Be familiar with the scope of changes found in the revised Common Rule
– Understand the process and research oversight concerns that brought us to this point in the effort to revise the Common Rule
– Understand the various possible fates of the revised Rule

Who should attend?

This webinar will benefit anybody who works in human subjects research.

1.5 – Hours of CRS Credit

Click here to register via Training Tracker


Barnett International Web Training

“Adverse Event Monitoring for CRAs”
Date: Thursday, February 9, 2017
Time: 11:00 AM – 12:30 PM CST
Location: Cancer Institute 10th Floor Strauss-McCaskill Rm 1017

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 – Hours of CRS Credit

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 – Hour of CRS Credit

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

Overview

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 – Hours of CRS Credit

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 – Hours of CRS Credit

Click here to register via Training Tracker