Reporting Requirements
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 trust between researcher and participant.
Surprise! “Checking the Box” Is Still an Option on the Federalwide Assurance (FWA)
Checking the box is still an option on the FWA. At this time, institutions must carefully consider whether it makes sense to check the box.
Beginner’s Guide to Investigator-Initiated Trials
In investigator-initiated trials, an investigator takes on the clinical study as both the sponsor and investigator. Learn more about IITs impact on the clinical research industry.
Q&A – The Must-Haves of FDA and Common Rule Reporting Requirements
Find out more about what to report to whom--and when--in the Q&A blog follow-up to our recent webinar. Read the answers to popular audience questions:
Community Consultation in the Time of COVID-19
COVID-19 complicates traditional models of community consultation. How should sites conducting planned emergency research approach community consultation?
Vendor Qualification vs Requalification Audits: What’s the Difference?
Audits to support your vendor qualification and management program should be conducted using a risk-based approach. Read more:
Human Research Protection Program Services
Download our info sheet to learn how Advarra can revitalize your human research protection program (HRPP) with customized consulting support
Part 11/Annex 11 Independent Audit and Compliance Assessment
Learn how the Advarra Consulting team deployed a proprietary Part 11 / Annex 11 assessment and mock inspection program.
Special Considerations for Pediatric Trials
In this white paper, get to know the key considerations for researchers conducting pediatric clinical trials.
UW Carbone Cancer Center Gains Visibility into Site Accrual with Insights
Monitoring accrual is a key responsibility for a cancer center administrator. From answering questions for leadership to preparing for a grant submission, knowing the ins and outs of a site’s accrual metrics can ensure greater operational efficiencies center-wide.
What Level of Review Does Your Study Need?
In this infographic, we share useful information for investigators to know which level of IRB review likely applies to their study.
The Challenge of Unproven Regenerative Stem Cell Therapies
Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.
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