SCRCM

Society for Clinical Research Coordination and Management

Society Scoops!

June 8th, 2022

SCRCM SCOOPS: Informed Consent: Who, What, Where, When, How

Session Overview:

Informed consent is an ongoing active process though which a researcher communicates key aspects surrounding research participation to a subject and a subject voluntarily communicates willingness to participate.  Informed consent starts at the time of the first research related interaction and continues through to the completion of subject’s participation. Navigating the ongoing consent communications throughout the course of a research study can be challenging for both the research staff and the research subject.

 

This session will provide a review of fundamental informed consent requirements, as well as, discussion of best practice and key stakeholder perspectives surrounding the conduct of the consent process over time.  Aspects of consent including patient facing education on the concept of clinical research and building patient trust in the research enterprise will be included. Clinical situations involving varying approaches to supporting effective and efficient informed consent will be presented.  Practical implications involved with when and how to approach subjects for ‘re-consent’ will be included.  Elements of consent pertaining to expectations for return of research results will be considered.    

 

Learning Objectives:

After completing this session, attendees will be able to:

  • Knowledge
    • Define ‘informed consent,’ the key stakeholders involved, and associated ‘process’ as related to human subject research with accuracy
    • Identify key federal regulatory code which sets forth informed consent requirements including in text references
    • Identify complex clinical situations which necessitate alteration to the standard informed consent process including at least two examples
    • Identify the time points at which timely re-consent is required and methods for updating participants with accuracy
  • Skill
    • Navigate to University of Pennsylvania resources governing expectations for informed consent
    • Describe what it means to participate in clinical research using patient-oriented lay terms
  • Behavior
    • Integrate concepts related to trust-building into research consent process
    • Adjust current practice to meet minimum regulatory and institutional expectation

For the presentation slides, Click HERE

For the presentation recording, Click HERE

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July 13th 2022

SCRCM SCOOPS: Compassionate Use: Streamlining FDA & IRB Submissions

Session Overview:

Single Patient Treatment (Compassionate) Use protocols are not research studies; rather, these activities are an extension of clinical care. Under FDA regulations (21 CFR 312.300), single patient ‘expanded access’ pathways allows for the treatment use of unapproved product outside of a clinical trial for a specific type of patient with ‘serious diseases or conditions’ only when ‘there is no satisfactory alternative therapy’ to treat the patient’s disease or condition. The primary purpose is to diagnose, monitor or treat a patient’s disease or condition. These extensions of clinical care, however, fall under the same compliance requirements and documentation obligations as FDA-regulated clinical trials given the manufacturer/sponsor of the product to be used as treatment has not yet received FDA authorization for commercial marketing in the United States.  Use of a product for clinical treatment prior to formal market authorization remains an ‘experimental’ use.  What is the process for requesting a treatment use of an unapproved product?  How long does the process take?

 

This session will provide a review of fundamental regulatory and operational concepts for physicians/administrative teams interested in pursuing treatment use of an unapproved product for their patient.  Experience based suggestions for timely and effective communication with manufacturers and internal stakeholders will be provided.  Best practice for streamlining submission through the IRB and FDA will be discussed.  The lifecycle of the treatment plan with associated minimum documentation and reporting expectations will be described. 

 

Learning Objectives:

After completing this session, attendees will be able to:

  • Knowledge
    • Define ‘single patient treatment use,’ and the key stakeholders involved with accuracy
    • Compare/contrast obligations for providing clinical care involving approved products and unapproved products
    • Describe the submission processes for obtaining IRB & FDA approval for a treatment use of an unapproved product in detail
  • Skill
    • Develop a baseline understanding of the timeline for providing care with an unapproved product
    • Align expectations in the communications provided to patients regarding unapproved treatment plans for improved clinical interactions
  • Behavior
    • Advocate for best care including unapproved options with confidence
    • Adjust current practice to meet minimum regulatory and institutional expectations

For the presentation slides, Click HERE

For the presentation recoding, Click HERE

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July 19th, 2022

RAES: Paying Patients to Participate in Clinical Trials: Undue, Unjust, or Understudied?

Session Overview:

For decades, providing patients with financial incentives for research participation has been controversial and variably regulated due to uncertainty regarding whether financial incentives serve as undue inducements by blunting peoples’ sensitivity to research risks, or unjust inducements by preferentially increasing enrollment among disadvantaged persons. Emerging normative analyses and a small number of empirical studies of how hypothetical offers of payments influence trial enrollment decisions have increasingly suggested that concerns with incentivizing research may be overblown. But without evidence of how real incentives influence participation in real trials, investigators, research sponsors, and regulatory bodies have rarely modified their practices or norms.

 

This talk will briefly overview of those early studies and conceptual points, and then describe the methods and results of two randomized trials of real incentives for participating in two real parent trials that were published in 2021.

Learning Objectives:

After completing this session, attendees will be able to:

  • Knowledge
    • Understand the designs and results of the only trials of real financial incentives in real clinical trials
    • Interpret these findings in the context of prior knowledge and theory
    • Identify the remaining unanswered questions

For the Presentation Slides Click, HERE

For the Presentation Video Click, HERE

 

 

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August 10th, 2022

SCRCM SCOOPS: How to Read the Clinical Trial Protocol

Session Overview:

The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial functions,) and ensures the safety of the trial subjects and integrity of the data collected. Often, this document can be 100+ pages in length and include complex figures and/or tables. What are the best practices for reading for comprehension? Are there approaches/strategies to use while reading a protocol to achieve operational success? This session will provide best practice for reading/interpreting clinical trial protocols aimed at ensuring site compliance with protocol requirements.

 

Learning Objectives:

After completing this session, attendees will be able to:

  • Knowledge
    • Describe best practices for approaching comprehensive reading of the clinical trial protocol
  • Skill
    • Develop a personal plan for reading for application of operational success
  • Behavior
    • Apply approaches discussed to current practice for efficiently/effectively reading clinical trial protocols.

For the presentation slides, Click HERE

For the presentation recording, Click HERE

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September 14th, 2020

SCOOPS: Online applications for Participant Contact and Recruitment

RE: SCRCM SCOOPS: Technology Applications for Participant Contact & Recruitment

Presented through SCRCM Educational Webinar Series via Zoom

 

Session Overview:

This session will provide an overview of technology platforms that are permitted for use under Penn Medicine/University of Pennsylvania; to support contacting and recruiting participants for clinical research studies. A brief description of the specific technology / method and considerations for research teams will also be described.  Participant outreach, recruitment resources at Penn Medicine for diverse strategies such as: online, prints ads, mixed media, in-person recruitment, EMR (electronic medical record), patient portal, social media, mobile apps will be reviewed.  

 

Learning Objectives:

After completing this session, attendees will be able to:

  • Knowledge
    • Appreciate the various methods their clinical research team can leverage to conduct recruitment to meet enrollment needs.
  • Skill
    • Navigate to key resources, guidance documents and tools to start using and exploring these methods of recruitment
  • Behavior
    • Adopt listed, learned methods to enhance or supplement recruitment strategies for ongoing clinical research studies.
    • Incorporate thinking through these strategies early during study start-up, ideally during study feasibility.

For the Presentation Slides Click HERE

For the Presentation Recording, Click HERE

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