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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October 12th, 2022

SCOOPS: Sharing Data and Biological Samples with Third Parties

RAES: Research Autopsy: Postmortem Principles: The Ethics and Legality of Autopsy Specimens for ResearchPresented through ACC CRU ORA Regulatory Affairs Educational Webinar Series via ZoomSession Overview:Rapid autopsy (RA) has been shown to be a powerful tool for advancing research at essentially no risk and with no distress to the contributing patient. Academic and health centers with a substantial investment in cancer research should consider using this emerging research support modality.  Rapid autopsy is a unique methodology that can overcome the necessary limitations of tissue sampling in living patients and has contributed substantially to the understanding of metastatic spread of cancer. Rapid autopsies are post-mortem examinations performed on an urgent basis (measured in hours) after the death of the patient. Sampling tissues during a rapid autopsy from patients with advanced malignancies provides unique research opportunities.

There are currently a relatively small number of RA programs in the United States with an additional few existing in Canada, Australia, and very recently in Europe as well. Some of these programs are focused just on one tumor type (like prostatic cancer), while others accept more wide varieties of patients. These programs may be directed by pathologists (usual), oncologists (frequent), or other researchers (occasional), though pathologist involvement is always important to a properly executed autopsy procedure as well as for selection of best quality tissue for sampling.   Patients can be either be referred by clinicians or nurses/social workers, usually when the they are admitted in a hospice care or during the enrollment in a clinical trial, but sometimes they may even self-refer. The consenting process in which the patient or the legal next of kin signs and gives consent to collect and use tissues for future research is very important. Autopsy consenting is usually separate from a study consent and, in some states, may only be completed by the legal next of kin after the patient’s death.

This session will include description of methodologies for postmortem research autopsy and associated ethical issues imposed.  Focus will be placed on the practical issues surrounding informed consent and state law associated with the conduct of the research autopsy.   Relevant background article attached.

For the presentation slides Click HERE

For the presentation recording Click HERE

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November 9th, 2022

SCOOPS: Protocol Noncompliance: Determination of Reportability and Submission

RE: SCRCM SCOOPS: Protocol Noncompliance: Determination of Reportability

Presented through SCRCM Educational Webinar Series via Zoom

Session Overview:

Clinical trial protocols are expected to be followed at all times and in call cases.  However, our investigators leading these protocols are academic clinicians; physicians, who by definition are unwaveringly passionate about delivering optimal patient care. At the same time, our investigators are researchers , who by definition are exceedingly enthusiastic to pursue scientific interests pushing forward novel potential therapeutic options for our patients.  What happens when the protocol does not provide for options as desired by the investigator in his/her role as a clinician?  How does the IRB and FDA view deviations from the protocol when they are rooted in delivering optimal patient care?  And what rises to the level of IRB reporting?

 

Attendees will be provided with guidance pertaining a review of IRB reportable noncompliance requirements (prospective and retrospective), tips and tricks on how to approach building a comprehensive deviation report and include best practice guidance on considering corrective/preventative actions.  This session will also include discussion of alternatives to continuing a participant on trial in order to provide optimal therapy and expectations in documentation associated.

Learning Objectives:

After completing this session, attendees will be able to:

  • Knowledge
    • Obtain understanding of types of protocol noncompliance and which types of noncompliance rises to the level of reporting
  • Skill
    • Navigate clinical trial protocols to understand options which can be leveraged to avoid situations of noncompliance
  • Behavior
    • Adopt best practices for identifying and reporting noncompliance in realtime

For the Presentation Slides Click HERE

For the Presentation Recording Click HERE

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November 16th, 2022

RAES: Prospective Deviations: IRB & FDA Consideration Differences

Session Overview:

Clinical trial protocols are expected to be followed at all times and in call cases.  However, our investigators leading these protocols are academic clinicians; physicians, who by definition are unwaveringly passionate about delivering optimal patient care. At the same time, our investigators are researchers , who by definition are exceedingly enthusiastic to pursue scientific interests pushing forward novel potential therapeutic options for our patients. 

 

On one hand, we are charged with facilitating the clinical trials, on behalf of the investigators, in the pursuit of science and development of exciting new therapies which are ultimately offered to patients as research subjects; on the other hand, we are charged with protecting our investigators and institution from risks inherent to the means by which these trials are often conducted.  Sometimes these roles become juxtaposed. What happens when the protocol does not provide for options as desired by the investigator in his/her role as a clinician? Are there steps to take, in advance, of protocol noncompliance which mitigate/minimize the risk to the study, site, and subject? 

 

Provisions for the conduct of human subjects research under Title 45 and Title 21 of the Code of Federal Regulations do not allow for alterations to the research plan (protocol) outside of the scope of a formal amendment prospectively approved by the applicable scientific and ethical oversight entities, except in the emergent case to remove a research subject from immediate risk or harm.  Yet we know and appreciate that there are time and in certain cases where this needs to happen. 

 

Attendees will be provided with guidance pertaining a how to proceed in consideration of intentional prospective protocol noncompliance.  Review of required correspondences (both internal and external to the study team/unit) as well as process for communications with essential and required review entities will be provided.  ACC CRU position and process will be described and regulatory processes illustrated.

 

Learning Objectives:

After completing this session, attendees will be able to:

  • Knowledge
    • Differentiate between the various types of intentional prospective protocol noncompliance
    • Describe the factors which contribute to determining if prospective protocol noncompliance is a ‘good idea’
  • Behavior
    • Understand the impact prospective protocol noncompliance
    • Implement process for communicating prospective protocol noncompliance with regulatory staff such that essential/required approval are obtained as applicable.

NOTE: RAES sessions are not recorded by the SCRCM and therefore we do not have access to publish a recording. 

 

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December 14, 2022

SCOOPS: Investigator Essentials: Delegation of Authority and 1572

Session Overview:

The PI of the study is responsible for maintaining and approving a list of appropriate and qualified staff members (Delegation of Authority log – DOA) for all aspects of the clinical research study.  In today’s reality, given our collaboration with the healthcare system and in a setting where the staff supporting the clinical research endeavor is numerous and ever changing, how is this accomplished?  What is the best format? And, how often or timely is this expected to be done? 

 

Additionally, the investigator is required to provide the sponsor (and by extension the FDA) with information about his/her qualifications and information about clinical site (including associated vendors) at which the clinical investigation is being conducted.  This information is provided on the FDA form 1572.  Additionally the form 1572 is the investigator’s commitment to follow pertinent FDA regulations—in sorts, a type of agreement between the investigator and sponsor for FDA regulated research.  What is required to be included on this form?  How specific does the investigator need to be with regard to the site staff and locations?  And, how often or timely are updates expected to be done? 

 

Given our mission to advance healthcare with the approval of novel agents and new treatment plans, the potential for our investigators to be inspected by FDA and other health authorities is ever increasing.  These documents are not simply an unnecessary administrative burden; by having these documents complete and compliant, you demonstrate and document oversight of your team and set the tone for appropriate PI oversight which increases the odds of a successful inspection. 

 

This session will be a review of the required forms, as well as, discussion of best practices for managing changes and corresponding supplemental source documentation.

 

Learning Objectives:

After completing this session, attendees will be able to:

  • Knowledge
    • Identify the key documentation requirements for the DOA and FDA Form 1572
  • Skill
    • Navigate the various supplemental source documents supporting the qualifications/licensure of staff and facilities listed on either/both documents
  • Behavior
    • Adopt best practices for creating and managing these documents over time

For the Presentation Slides Click HERE

For the Presentation Recording Click HERE

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January 11th, 2023

SCOOPS: The Role of Research Compliance within the Clinical Research Enterprise 

Session Overview:

This session will provide the research community with translational guidance tools to facilitate research compliance in their program and prepare them for regulatory inspections by the FDA or other external regulatory bodies. Experience based suggestions for effective preparation and communication with the FDA and relevant stakeholders will be provided. Best practices adopted by academic compliance offices to identify and mitigate the major areas of risk will be discussed.

 

Learning Objectives:

After completing this session, attendees will be able to:

  1. Knowledge
  • Define best practices for identifying and mitigating risk to clinical research
  • Identify the principles driving research team inspection readiness and best practices to prepare for and host an FDA inspection

 

  1. Skill
  • Navigate to key resources, and tools which can be leveraged to prepare research teams for inspection readiness.

 

  1. Behavior
  • Apply approaches discussed to current practices to develop a strategy for inspection readiness.

For the Presentation Slides Click HERE

For the Presentation Recording Click HERE

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