The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. Clinical research in pediatric populations must follow the same regulations that adult clinical research follows, yet there are additional safeguards for children in clinical research, challenges associated with consent and study management for families and nuances in these populations that we don’t experience in the adult clinical research community. When you engage a child for participation in a clinical research program, you are engaging the entire family. Parents have a different risk/benefit profile for their child than they do for themselves. Navigating this complex environment with compassion, integrity and processes that embed compliance into every interaction are critical to protecting this vulnerable population and ensuring we can bring the best treatments forward as quickly as possible. Whether you're just getting started in pediatric clinical research or you have decades of experience, this program is designed to elevate your understanding and application across the regulatory environment, informed consent and assent, recruitment and retention, feasibility, budgeting, contracting and financial management with compliance tips and tricks along the way. 

LEARNING OBJECTIVES

• Discuss ethical considerations when conducting clinical research in the pediatric population
• Discuss guidelines to writing research informed consent and assent documents
• Discuss how to adequately review the protocol and source documents, list the documentation needed, discuss how to identify obstacles that may occur and the importance of communication amongst the study teams during study start up
• Discuss special considerations for developing pediatric research study budgets including a review of "hidden costs"
• Discuss monitoring and auditing issues specific to pediatric research
• Discuss the compliance challenges associated with conducting clinical trials and one site’s strategy to address this challenge

Please contact us with any questions or concerns at education@socra.org

This learning module is intended to encourage the reader to maintain an understanding of current activities involved in the conduct of research involving human subjects. The module offers one SOCRA continuing education credit to those who complete the review and correctly answer 9 of the 10 questions. There is one bonus question at the end. 

The module is offered at no cost as a public service.

This recertification module focuses on recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products.

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Upon completion of this course, the attendee should be able to discuss recent issues, changes, and/or updates in the regulatory environment.

SOCRA's Education Committee

SOCRA's Education Committee has created this module to help clinical research professionals stay updated on recent changes in the regulatory environment.

Ms. O’Kelly Phillips will discuss how data collection and management were structured in a large CMS demonstration project involving multiple data sources, including direct input from 40 partnered nursing facilities. Lessons learned throughout the project with attention to best practices for approaching managing projects with complex data structure in investigator-initiated grants and trials will be highlighted. (.75 CE)

OBJECTIVE: Discuss best practices and potential approaches to managing projects involving complex data collection structures.

Start Date: 12/22/23

Termination Date: 12/22/26

The FDA allows for charging for investigational products used in clinical research under certain circumstances. The federal regulations also state that participants should be informed of any additional costs that may result from participation in research. Recent “research studies” are using this guidance as a loophole to charge participants for studies that may not create generalizable knowledge. Ms. Oeser will review the ethical issues involved in recent pay-to-participate “research studies” and how these may violate the pillars of respect of persons, beneficence, and justice.

OBJECTIVE: Discuss concrete tactics that can be used to prevent "firefighting" when project-managing clinical trials.

Start Date: 12/22/23

Termination Date: 12/22/26

You may happen to work with a colleague or a direct report who is difficult to please. They may have a special opinion and never want to compromise or they may think they are always right and everyone else is wrong. They want to do things their own way and poor you if you obey. Being snappy and arguing can be their norm, at the same time they still can perform very well. The speakers will share approaches and methods to manage difficult employees, including corrective and preventive measures, supported by real-life examples.

OBJECTIVE: Discuss types of difficult employees and how to feel more comfortable working with or managing difficult members of the team.

Start Date: 12/22/23

Termination Date: 12/22/26

Ms. Rugloski will provide tips and examples for creating and implementing a Project Team Member Transition/Training strategy to ensure effective and efficient project team member transitions. The session will end with an activity comprised of an interactive mind-mapping (‘brainstorming’) exercise with audience participation.

OBJECTIVE: Discuss key elements for inclusion within a project team member transition/training plan.

Start Date: 12/22/23

Termination Date: 12/22/26

A study’s protocol must be followed in order to maintain compliance. In order to demonstrate compliance, the study team should implement dynamic documentation that clearly and concisely tells a subject's story of participation in the clinical study. By prioritizing adherence to the protocol and documentation of the subject's experience, the study team will successfully demonstrate compliance and mitigate risk. 

OBJECTIVE: Discuss document creation and maintenance to support procedures described in the IRB-approved protocol.

Start Date: 12/22/23

Termination Date: 12/22/26

According to Paulo Coelho, “the secret to life is to fall down seven times and to get up eight times”. Resilience, from the Latin “to leap back”, is the process and experience of being disrupted by change, opportunities, stressors and adversity and accessing gifts and strengths to grow stronger. This session examines diverse aspects of resilience or “bounce-back ability” in the workplace including the importance, components and development of resilience. The session also includes a brief assessment of personal resilience as well as how to design a resilience development plan.

OBJECTIVE: Discuss diverse aspects of resilience or “bounce-back ability” in the workplace and how to design a resilience development plan.

Start Date: 12/22/23

Termination Date: 12/22/26

Identifying common oncology research queries and trends can provide added efficiency in addressing them. Understanding the rationale for these common queries can provide insight into methods by which they can be prevented. Finally, understanding how to successfully resolve queries is a critical skill for the clinical research professional.

OBJECTIVE: Discuss the challenges unique to the “experienced patient” with cancer relapse who is being asked to consider enrolling in a clinical trial.

Start Date: 12/22/23

Termination Date: 12/22/26

The value of implementing preventive quality assurance measures is essential to ensuring research compliance. Significant findings during an inspection or audit can results in damaged reputations, loss of existing or future funding, and impact the confidence of the research team. For a research team to be successful, it is vital they proactively identify risks and implement measures to ensure patient safety and the integrity of the research. This proactive approach provides opportunities for coaching, mentoring, and training in a supportive non-punitive way. Preventive measures can provide confidence within the research team, preventing the crisis mode mentality that often precedes an audit or inspection. 

OBJECTIVE: Understand the value of prevention and how to implement preventive measures.

Start Date: 12/22/2023 

Termination Date: 12/22/2026