Sites
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.
Informed Consent in Research and Individuals with Impaired Decision-Making Capacity
This blog outlines the principle of equitable selection and the requirement for additional safeguards for certain vulnerable groups.
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.
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?
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.
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