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. […]
Research Compliance
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
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.
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.
Changes to NIH Policy for Issuing Certificates of Confidentiality: What You Need to Know
On October 1, 2017, NIH’s policy for certificates of confidentiality (CoCs) changed so that CoCs are now automatically issued for
Informed Consent in Research and Individuals with Impaired Decision-Making Capacity
Food and Drug Administration (FDA) regulations and the Common Rule require that the selection of participants in research is equitable.
Non-English Speaking Research Subjects: What’s in the Regs?
Recently, the clinical research community has been making efforts to include more diverse subject populations in clinical studies. Sec. 907
Evaluating eConsent: Some Considerations from an IRB Perspective
At Advarra we’ve been seeing more and more eConsent studies recently, which is great—eConsent technology can often better inform participants
Planning Gene Therapy Research? Plan for IBC Review
The completion of the human genome project and advances in genetic engineering have paved the way for clinical trials involving
Component Analysis: Analyzing Benefits and Risks of Individual Interventions to Ensure Appropriate Research Participant Protections
A major element of any IRB review is the examination of potential benefits and risks to study participants. In studies
IRB Review of Adaptive Design Studies
The popularity of adaptive design in clinical research continues to grow. Adaptive design can be more efficient than traditional study
“Single IRB” vs “Central IRB” – What’s the Difference?
With the rise of single IRB (sIRB) mandates, understanding the nuances between sIRB and central IRB (cIRB) is crucial for multisite studies.