Series: Ask the IRB & IBC Experts
WCG’s IRB & IBC Review professionals get questions about clinical research all the time: from researchers, clinical team members at biopharma companies, and from members of institutional IRBs. We know that for many of the questions, the person asking is not the only one struggling with that issue. We’ve built this forum as an immediate and less formal way to share information across the clinical research community.
FDA & ICH
What documentation needs to be submitted to the IRB for an IND exemption request?
Blog Posts
Ethics in Clinical Research
Does research involving retrospective review of patient charts require IRB review?
Blog Posts
Participant Recruitment
Is IRB review required when linking to clinicaltrials.gov postings on patient advocacy websites and newsletters?
Blog Posts
Ethics in Clinical Research
Do parents need to accompany adolescents at each research-related office visit?
Blog Posts
Clinical Trial Safety
What are IRB submission requirements for post marketing safety reports?
Blog Posts
Ethics in Clinical Research
May I pay a physician for referring a patient to our study?
Blog Posts
Clinical Endpoints
Regulatory Challenges in Pediatric Drug Development: The European Perspective
Blog Posts
Clinical Trial Safety
Submitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB
Blog Posts
Series: Ask the IRB & IBC Experts
What documentation is needed to prove a parent’s legal authority to consent for a child’s participation in research?
Blog Posts
Hybrid & Decentralized Trials