Updated IRB Policy on ICH-GCP Compliance for Research Conducted in the US
After reviewing current regulatory guidances and industry best practices, Advarra has updated its IRB policy on applying ICH-GCP Guidelines to US research. The IRB will only enforce ICH-GCP compliance in the ICF(s) when the client submits the ICF(s) with ICH-GCP elements included. This revised policy is effective immediately.
The ICH-GCP Guidelines are voluntary for research conducted in the US. Research protocols being conducted in multiple countries often include a statement regarding ICH-GCP compliance, but the US ICF the IRB receives might not include the additional elements required by ICH-GCP. In these situations, the IRB will not modify the ICF to include those elements. For ICFs that are submitted with the ICH-GCP elements included, the IRB will review the information to ensure compliance.
For research overseen by Advarra that is conducted outside of the US (for example, research in Canada), local regulations may require ICH-GCP compliance. In these circumstances, the IRB will apply ICH-GCP requirements as appropriate.
For more information, please contact Business Development.