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.
Reporting to the IRB: Serious Adverse Events (SAEs) in Drug Studies
Learn what the regulations say about IRB reporting requirements for serious adverse events and how undefined “gray areas” can be addressed.
Ethics and Research with Children (2nd Ed): Social Media and Pediatric Research Recruitment
Luke Gelinas contributed to the essay Social Media and Pediatric Research Recruitment in the volume Ethics and Research with Children: A Case-Based Approach (2nd ed.).
Advarra IRB Chairperson Featured in PRIM&R Blog About Patient Centered Outcome Research
Advarra IRB Chairperson Luke Gelinas was recently featured in the PRIM&R blog post Recommendations for Oversight of Patient-Centered Outcomes Research
Integration Update: Leading Compliance Adherence
The Advarra team is proud to announce that all major integration activities are now complete.
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.
Making a List, Checking It Twice… The Revised Common Rule Is Coming to Town!
Judith Carrithers and discuss a checklist of action items to consider and complete prior to the revised Common Rule compliance date.
Oversight Challenges with Patient Centered Outcomes Research
In this webinar, Luke Gelinas, PhD, IRB Chair at Advarra, lays out some of the oversight challenges raised by PCOR.
IRB Services: Canadian Review
Advarra’s Canadian review service combines local, expert oversight with streamlined processes and the most extensive site reach in Canada.
What’s the Difference Between Right to Try and Expanded Access?
Let’s take a look at the basics of what each program does and does not do for patients seeking to access investigational therapies.