Top 10 Educational Resources of 2021
The year 2021 brought many advancements in the clinical research industry. We’ve pushed for more diversity and inclusion in clinical trials, decentralized clinical trials have gained attention, among many more improvements. As the end of the year draws near, let’s take a look back at popular blog posts and webinars garnering the most interest from research community members like you.
Top Blog Posts
Q&A – Regulatory Fine Points: Exploring 21 CFR Part 11 Validation
James Riddle, Shannon Roznoski, and Stuart Cotter of Advarra presented Regulatory Fine Points: Exploring 21 CFR Part 11 Validation, reviewing how the partnerships between software vendors, research institutions, and other stakeholders work to support regulatory guidelines. They discussed in detail which parts each party is responsible for when building, implementing, and maintaining clinical trials software in a government-regulated process.
Defining Decentralized Clinical Trials and Understanding Their Nuances
It’s important to understand decentralized clinical trials are not one-size fits-all, and oftentimes, a hybrid approach is necessary. This blog offers considerations when rolling out decentralized clinical trials across multiple jurisdictions where laws, technological uptake, and populations will vary.
Informed Consent: When, Why, and How It’s Obtained
Aside from being a regulatory and ethical requirement, informed consent is a good way to ensure participant knowledge and develop a foundation of trust between the researcher and participant. This blog outlines the informed content process.
FDA Inspection Readiness: Preparing for an Inspection
A Food and Drug Administration (FDA) inspection of an investigational site can occur at any time, and preparation is critical to an efficient inspection. By understanding what the FDA typically looks for in its inspections, sites can make sure all documentation is ready for review and all staff are properly trained to interact with the inspector.
DMC vs IRB: What’s the Difference?
In this blog, we will take a look at the specific role data monitoring committees (DMCs) play in overseeing research, and how institutional review boards (IRBs) rely on the independent DMC’s oversight of interim trial data to ensure an adequate safety monitoring plan is in place.
Budgeting and Billing Compliance in Study Activation
Wrongfully billing items and services to a participant’s insurance is an ever-growing risk in clinical research. Advarra’s Senior Business Operations Services Manager Jake Meyer discusses common strategies sites take to protect themselves from such financial risks. From making do with a tight budget to taking less conventional approaches, learn how you can ensure reliable and maintained timelines, even amid fluctuations in demand.
Leveraging Data to Lead and Manage the Research Mission: Data-Driven Decision Making at all Levels of the Organization
With data all around us and easier than ever to capture, we should use it at all levels of our organizations to drive strategy and manage operations. In this webinar, Teri Grieb, Associate Dean for Research Strategy and Senior Director for Research Administration, and Kate Huffman, Associate Director of Operations for the Clinical Trial Support Units at Michigan Medicine discuss how their organization uses data at all levels to lead and drive the research enterprise and day-to-day research operations.
Diversity and Inclusion: Who is Responsible – Site, CRO or Sponsor?
Attaining a diverse trial patient population is crucial to the success of any clinical trial. But who is truly responsible for maintaining a diverse and inclusive participant database? In this webinar, Judy Galindo, Monica Cuitiva, Ashley Margo, Dan Sfera, and Chris Sauber, the Co-Founders of Latinos in Clinical Research, outline why it’s important to recruit diverse patients of all backgrounds and why protocols should be more inclusive.
Do You Have Appropriate Oversight? Understanding the Role of DSMBs
Clinical trials are complex. Independent DMCs or data safety monitoring boards (DSMBs) provide necessary support to sponsors and contract research organizations (CROs) in the conduct of clinical trials. In this webinar James Riddle, Advarra Vice President of Research Services & Strategic Consulting, and Barbara Schneider, Advarra Executive Director of Biostatistical Services, take a look at the role and function of independent DMCs from charter creation through interim data analysis.
FWAs Part 2: Managing a Federalwide Assurance and IRB Registration
Join Advarra’s regulatory experts Lisa Rooney, Managing Director, Institutional Research Center of Excellence, and Lauren Hartsmith, Director of Regulatory Affairs, in another discussion of institutional responsibilities, digging deeper into the federalwide assurance (FWA) topic and adding IRB responsibilities to the mix. They answer questions such as:
- How to obtain an FWA
- When to update one
- When an institution has to register an IRB
- How an IRB registration fits in with the FWA process
- What to do if an IRB no longer reviews research
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