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Webinars

Association for Clinical Research Professionals

“Return of Research Results to Participants: Ethical & Operational Challenges”
Date: Wednesday, May 24, 2017
Time: 11:00 AM – 12:00 PM
Location: College of Public Health G228

Overview

Sharing research results has been universally accepted as a need and duty toward research participants. Current regulatory trends will soon make it routine for our industry. This session will provide an update on the current regulations, guidance and international effort toward sharing research results with participants. Each member of the research team will be called upon to anticipate how their role will evolve to accommodate this important step in the research process with practical ways to implement the sharing of research results with the most important member of the research team – volunteer participants.

Speaker, Robert Romanchuk, is currently Vice-Chair at Schulman IRB and has 2 decades of experience in research operations and human subjects protections. His achievements include building and managing a central research operation for a large community health system, and numerous roles in the human subjects protections arena. He holds a BSHS in Clinical Research Administration from the George Washington University and CIP, CRCC, and CHRC credentials.

During this presentation, you will learn:

  • Recount the purpose and regulatory foundation for reporting research results
  • Analyze the impact and implications of sharing research results on the clinical trial process and stakeholders
  • Devise practical and effective ways to incorporate the sharing of research results in the clinical trial life cycle

1 CRS credit hour

Click here to register via My Compass


Audio Educator

“FDA Enforcement of 21 CFR 11 Compliance”
Date: Thursday, May 25, 2017
Time: 12:00 PM – 1:30 PM
Location: College of Public Health G226

Overview

Understand FDA’s View of Enforcement Under Part 11 and How You Can Prepare Your Company for an Upcoming Inspection.

Through its Part 11 inspection and enforcement program, the FDA has continued with its enforcement action. 30 warning letters were issued by the FDA related to Part 11 violations in the last three years alone. Most of the citations were related to security, integrity and availability of electronic records while some were related to software and computer systems validation.

However, typically, citations are against the predicate rules, not part 11 itself. This is very confusing and makes it difficult to determine what FDA assesses in these inspections.

To get a better insight, join expert speaker Angela Bazigos in this live webinar as she helps you get a better understanding of what 21 CFR 11 means and why and how it was implemented. She will also discuss FDA’s view of what is enforced under Part 11 inspections, and how you can prepare your company for the upcoming Part 11 inspection.

Session Highlights:

  • 21 CFR 11 then and now: a brief history of 21 CFR 11 and what it looks like today
  • Part 11 Basics
  • FDA’s view of 21 CFR 11 Compliance
    • FDA acceptance of data: Electronic and paper
    • Computerized systems and eData
    • Basis for Part 11 compliance and purpose of protection and validation
    • Diverse nature of “source” and how to protect and preserve it
    • Purpose and goal of 21 CFR 11 BIMO inspection
    • Inspection of electronic records – BIMO
  • The 10 deadly sins that break compliance
  • Examples of 21 CFR 11 citations
  • Preparing your company for a successful part 11 inspection

1.5 CRS credit hours

Click here to register via My Compass


FDANews

“ICH GCP E6 Revisions: The New Standard
Date: Tuesday, May 30, 2017
Time: 11:00 AM – 12:30 PM
Location: College of Public Health G228

Overview

Every clinical trial operator will feel the impact of the major revision of the ICH E6.

The revision, known as ICH E6 (R2) GCP, will impose new requirements to use state-of-the-art technology … force changes in trial design, conduct, oversight, recording and reporting … and all the while, continue insisting on highest standards of human protection and data integrity.

And that’s just for openers. Also slated for updating: Standards regarding electronic records and essential documents to boost trial quality.

As with all such documents, the requirements are complex and technical. Yet failure to understand and comply risks the wrath of regulators from the U.S. FDA to the Japanese Ministry of Health, Labor, and Welfare (MHLW).

FDAnews has retained the services of an expert to help you understand, and comply with, this major change to clinical trial conduct.

During this 90-minute session, Dr. Susan Leister will help you master:

  • Major changes set forth under ICH E6 (R2) GCP
  • Potential challenges to compliance
  • Impact of compliance changes on your organization
  • How to implement the changes most efficiently and with least disruption
  • Unification of multiple countries — including EU member nations, Japan, Canada and Switzerland — for approval

1.5 CRS credit hours

Click here to register via My Compass


PRIM&R

“Focus on the Revised Common Rule: Informed Consent”
Date: Thursday, June 1, 2017
Time: 12:00 PM – 1:30 PM
Location: College of Public Health G228

Overview

  • This webinar will discuss new elements of the Rule impacting informed consent, including:

    • Changes in the basic and additional elements of the informed consent
    • New requirement that consent documents begin with a concise presentation of key information, presented in a manner that facilitates the subject’s understanding
    • New broad consent option for the collection, storage, and secondary research use of biospecimens or identifiable private information
    • Changes in the criteria for waiver of informed consent related to screening/recruitment and research involving the use of identifiable biospecimens and/or data
    • Clarifications regarding the determination of who is a legally authorized representative
    • Increased clarity regarding requirements/methods for documentation of informed conse

1.5 CRS credit hours

Click here to register via My Compass


PRIM&R

“Focus on the Revised Common Rule: Exemption Categories and Select Types of Review”
Date: Thursday, June 8, 2017
Time: 12:00 PM – 1:30 PM
Location: College of Public Health G230

Overview

  • This webinar will examine and discuss key operational and administrative provisions in the new Rule, including:

    • Activities classified as “not research”
    • New exempt categories for low-risk studies
    • Limited IRB review
    • Changes related to expedited review
    • Circumstances under which continuing review is no longer required
    • Elimination of the option for FWA holders to check the box, and potential impacts on review

1.5 CRS credit hours

Click here to register via My Compass


Association for Clinical Research Professionals

“Sponsor Best Practices From a Study Coordinator Perspective: Changes Sponsors Should Make Today”
Date: Tuesday, June 13, 2017
Time: 11:00 AM – 12:00 PM
Location: College of Public Health G228

Overview

The Study Coordinator rarely has the opportunity to provide any type of feedback to study sponsors and their input is not often requested during study design. Through focus groups and survey administration, original research was conducted to determine actionable changes for sponsors to make to reshape clinical trial management with Study Coordinators in mind. Data will be presented as a case study to review research findings, the operational changes made based on findings and the tools used to facilitate changes. Tools and templates will be shared to support organizational changes, including: phone scripts, milestone surveys, mini protocols, and study checklists. Attendees will be armed with the knowledge needed to take the best practices back to their own organizations and assess the opportunity to implement change.

Speaker, Kristen Perkins, MS, CCRP, is a Clinical Research Associate within Trial Management at TESARO, an oncology-focused biopharmaceutical company within the Greater Boston area. Kristen has nearly 10 years of global clinical operations experience in multi-center Phase II-IV trials within a variety of therapeutic areas. Prior to joining TESARO, Kristen worked as a Site Manager, Clinical Trial Associate, Clinical Research Coordinator and Research Assistant. Her experience at top academic medical centers and a leading global CRO ignited her interest in project and site management.

During this presentation, you will learn:

  • Explain sponsor best practices for designing clinical trials with study coordinators in mind
  • Apply recommendations to clinical trial operations activities
  • Analyze opportunities for improvements at individual organizations

1 CRS credit hour

Click here to register via My Compass


PRIM&R

“Focus on the Revised Common Rule: Biospecimens & Identifiable Private Information”
Date: Thursday, June 15, 2017
Time: 12:00 PM – 1:30 PM
Location: College of Public Health G230

Overview

This webinar will discuss provisions specific to research with biospecimens and identifiable private information under the new Rule. Specific topics will include:

  • The expansion of exempt categories that allow:
    • Use and recording of identifiable information
    • Secondary use of identifiable biospecimens and information
    • Storage, maintenance and secondary research use of identifiable private information and biospecimens
  • New, limited IRB reviews for select exempt categories
  • The role of HIPAA
  • New elements in informed consent related to research with biospecimens and identifiable private information

1.5 CRS credit hours

Click here to register via My Compass


PRIM&R

“Focus on the Revised Common Rule: Implications for SBER (Social, Behavioral and Educational Research)”
Date: Thursday, June 22, 2017
Time: 12:00 PM – 1:30 PM
Location: College of Public Health G230

Overview

This webinar will discuss elements of the new Rule that will impact oversight of SBER, including:

  • New definitions of research to exclude scholarly and journalistic activities
  • The expansion of exempt categories that allow:
    • Use and recording of identifiable information
    • Storage, maintenance and secondary research use of identifiable private information
  • Broad consent for identifiable private information
  • Exemptions for research involving benign behavioral interventions

1.5 CRS credit hours

Click here to register via My Compass


Quorum Review Webinar

“Adopting eConsent in Research: Security, Privacy and Regulatory Considerations”
Date: Tuesday, Jun 27, 2017
Time: 12:00 PM – 1:00 PM
Location: College of Public Health G228

Overview

eConsent adoption is on the rise, and with that comes a heightened focus on the compliance of eConsent platforms and the protection of data. This webinar will walk through the security and privacy requirements related to eConsent, as well as other compliance considerations for sponsors, CROs, research sites, and IRBs. Specifically, attendees will learn the practical impact of:

  • 21 CFR Part 11 (Part 11)
  • The HIPAA Privacy and Security Rules
  • FDA Guidance on eConsent
  • Little-known other requirements related to eConsent

1 CRS credit hour

Click here to register via My Compass