Informed Consent Changes in the Revised Common Rule
Many of the revised Common Rule’s changes aim to make informed consent more meaningful, so that research subjects have the...
Do I Need to Comply With the Revised Common Rule?
Most requirements of the revised Common Rule go into effect January 21, 2019*. While many US researchers are aware of...
Reporting to the IRB: Serious Adverse Events (SAEs) in Drug Studies
At Advarra, we often get questions about exactly what events should be reported to the IRB. We understand that “reportable...
Infection Control and Biosafety in Gene Therapy Research
Gene therapy research has moved from the realm of science fiction to mainstream clinical research. The maturation of this field...
Integration Update: Leading Compliance Adherence
The Advarra team is proud to announce that all major integration activities are now complete. SOPs have been harmonized; staff...
ICH-GCP Guidelines and Research Conducted in the US
When research is being conducted in multiple countries, determining which regulations apply to which country’s sites can sometimes be complicated....
What’s the Difference Between Right to Try and Expanded Access?
The right to try movement and recent passage of the federal right to try law have renewed public interest in...
The GDPR and Its Impact on the Clinical Research Community (Including Non-EU Researchers)
The European Union’s General Data Protection Regulation (GDPR) goes into effect May 25, 2018, replacing the existing EU Data Protection...
Integration Update: Recent Milestones Completed
The Advarra team has worked to fully integrate our processes and policies to provide clients with unified capabilities and support...
Integration Update: Expanded FAQ for Advarra Merger Efforts
The Advarra team (formerly Chesapeake IRB and Schulman IRB) continues to integrate our processes and policies, leveraging mutual strengths in...