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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.
Infection Control and Biosafety in Gene Therapy Research
Given the growth in gene therapy research, sponsors, CROs and sites have become increasingly curious about the requirements to be able to conduct such studies.
Integration Update: Leading Compliance Adherence
The Advarra team is proud to announce that all major integration activities are now complete.
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.
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 for IRB, IBC and global research quality and compliance consulting services.
Integration Update: Expanded FAQ for Advarra Merger Efforts
The following FAQ expands upon previous FAQs we’ve published and provides additional insight into the integration process.
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.
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 process and policies. We are committed to being transparent throughout this integration, so we've assembled the following FAQ to keep you updated.
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.
Schulman IRB and Chesapeake IRB Merger and Integration: What You Need to Know
Chesapeake IRB and Schulman IRB are merging under the new organizational name, Advarra. This FAQ addresses commonly asked questions about this merger.
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.