If I’d Known You Were Coming, I’d Have Translated the Consent: Short Form Consents and the Unexpected Non-English Speaking Participant
Regulations require study information be presented in a language understandable to participants, including the informed consent document and process.
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.
Evaluating eConsent: Some Considerations from an IRB Perspective
eConsent technology can often better inform participants than just the traditional paper consent, which is great from an IRB perspective.
5 Steps to Follow when Shopping for a Validated EDC System
Shopping for a validated EDC system can seem like a daunting task. Learn five steps that make the process less confusing.
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 human gene transfer
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.
IRB Review of Adaptive Design Studies
Learn why the popularity of adaptive design in clinical research is continuing to grow!
The Six Characteristics of an NCI-Designated Cancer Center
A key component of the CCSG is to demonstrate six major characteristics of an NCI-designated cancer center. Learn more about each characteristic.
“Single IRB” vs “Central IRB” – What’s the Difference?
Is there a difference between the terms sIRB and cIRB?
The Beginner’s Guide to an Electronic Data Capture (EDC) System
An Electronic Data Capture system stores patient data collected in clinical trials. Learn the basics & functionality of EDC systems.
Deciphering the CRC Career Path: Key Skills and Responsibilities
Interested in becoming a clinical research coordinator? Understand the key skills and experiences sites look for.
Beginner’s Guide to Clinical Trial Performance Metrics
Learn what clinical trial performance metrics are, why they are important and which key metrics for clinical trials you should be measuring.