Research Compliance
Can Ethics Review Catch Up to the CBD Craze?
CBD, a non-psychoactive cannabinoid, is experiencing a massive surge in popularity, but clinical research lags behind in verifying effective uses.
After the Compliance Date: Revised Common Rule FAQs (Or: Why We Cancelled Our February Webinar)
We have cancelled our webinar “After the Compliance Date: Revised Common Rule FAQs,” which was originally scheduled for February 28.
Informed Consent Changes in the Revised Common Rule
If your research must comply with the revised Common Rule, you’ll need to update the way you write ICFs to meet the new requirements.
Do I Need to Comply With the Revised Common Rule?
While many US researchers are aware of the coming Common Rule changes, not everyone is sure whether they will need to comply with the revised regulations.
ICH-GCP Guidelines and Research Conducted in the US
Learn the basics of how ICH-GCP Guidelines can impact the study ICF and how we at Advarra came to our updated policy on the topic.
IRB Services for Institutional Sites
Advarra serves as your external support and compliance partner for everything from single investigational sites to multisite research consortia and therapeutic networks.
The GDPR and Its Impact on the Clinical Research Community (Including Non-EU Researchers)
Please note that this material is provided for informational purposes only and not for the purpose of providing legal advice.
International Research and Research Ethics Review
Clinical research continues to grow throughout the world, with researchers looking outside the US for new and diverse subject populations to help develop and improve investigational therapies. Lauri Carlile, VP of Operations at Advarra, discusses the basics of ex-US research ethics review for US-based researchers.
Data Collection in Clinical Trials: 4 Steps for Creating an SOP
Learn the necessary steps to create an effective SOP for data collection in clinical trials when using an electronic data capture (EDC) system.
Changes to NIH Policy for Issuing Certificates of Confidentiality: What You Need to Know
NIH’s policy for certificates of confidentiality changed so that CoCs are automatically issued for all NIH-funded research that uses sensitive information.
Informed Consent in Research and Individuals with Impaired Decision-Making Capacity
This blog outlines the principle of equitable selection and the requirement for additional safeguards for certain vulnerable groups.
Non-English Speaking Research Subjects: What’s in the Regs?
Recently, the clinical research community has been making efforts to include more diverse subject populations in clinical studies.