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.
Series: Ask the IRB & IBC Experts
Is informed consent needed for post-market patient registry?
Blog Posts
FDA & ICH
Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
Blog Posts
Ethics in Clinical Research
What questions can be asked when screening patients prior to them signing consent?
Blog Posts
Ethics in Clinical Research
Ask the Experts: When Do I Report a Protocol Deviation to the IRB? Do I Need To Report a Summary of Deviations at the Time of Continuing Review?
Blog Posts
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