Research Compliance
Ethical and Practical Concerns About IRB Restrictions on the Use of Research Data
Judith Carrithers co-authored the article Ethical and Practical Concerns About IRB Restrictions on the Use of Research Data in Ethics & Human Research.
Q&A – Study Startup Success for the New Generation of Genetically Engineered Vaccines
Daniel Eisenman answers questions from his latest webinar Study Startup Success for the New Generation of Genetically Engineered Vaccines.
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.
Is GDPR Coming to the US? CCPA and Its Impact on Research
New California regulations apply to companies who have information about CA residents regardless of where the company is located. Read more:
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:
Getting “Engaged” in the Time of COVID
When using remote sites to perform clinical trial procedures, keep in mind things like whether remote sites are considered "engaged" in research. Read more:
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?
How Oncology Research Is Advancing Better Research
Innovations in oncology have sparked advancements in the clinical trial industry and empowered COVID-19 research. Read more:
IRB Review of Virtual Trial Technologies
What are some of the key issues IRBs face when reviewing research that includes virtual trial technology? Read more:
Accelerating the Recovery – Design and IRB Review of Safety Monitoring Plans During COVID-19
COVID-19 is rapidly changing the way research is conducted, namely how to conduct effective participant safety monitoring at a distance. Read more:
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:
The Opioid Crisis in America
Combating the opioid crisis requires urgent, evidence-based approaches that address clinical, research, and education issues. Read more:
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