Research Compliance

Please note that this material is provided for informational purposes only and not for the purpose of providing legal advice.

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.

Learn the necessary steps to create an effective SOP for data collection in clinical trials when using an electronic data capture (EDC) system.

NIH’s policy for certificates of confidentiality changed so that CoCs are automatically issued for all NIH-funded research that uses sensitive information.

This blog outlines the principle of equitable selection and the requirement for additional safeguards for certain vulnerable groups.

Recently, the clinical research community has been making efforts to include more diverse subject populations in clinical studies.

eConsent technology can often better inform participants than just the traditional paper consent, which is great from an IRB perspective.

The completion of the human genome project and advances in genetic engineering have paved the way for clinical trials involving human gene transfer

A major element of any IRB review is the examination of potential benefits and risks to study participants.

Learn why the popularity of adaptive design in clinical research is continuing to grow!

Is there a difference between the terms sIRB and cIRB?

An Electronic Data Capture system stores patient data collected in clinical trials. Learn the basics & functionality of EDC systems.