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
Reviews
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
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
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.
Clinical Research Acronyms and Abbreviations You Should Know
New to clinical research? Learn the meaning of common industry acronyms and abbreviations including eCRF, IIT, PI, TMF, and more.
Integration Update: Revised FAQ for Advarra Merger Efforts
Since November 2017, the Advarra team (formerly Chesapeake IRB and Schulman IRB) has been working to integrate our processes and