Protocol Resource Impact Assessment (PRIA)
The PRIA is a prospective review to ensure that the Clinical Center (CC) has the expertise, equipment, and resources needed to successfully conduct clinical trials.
The PRIA is a prospective review to ensure that the Clinical Center (CC) has the expertise, equipment, and resources needed to successfully conduct clinical trials.
A CC Pharmacy Review is included in the PRIA review. Additionally, all protocols submitted through the PRIA process will receive a regulatory assessment from the Office of Research Support and Compliance (ORSC) Regulatory Support Section. This review highlights regulatory items related to FDA (21 CFR 312 and 21 CFR 812) that you, as the Principal Investigator (PI), must address in the protocol and that the IRB may need to consider during its review. Depending on the institute, you may receive the review directly or it may be sent to your Institute’s regulatory support office.
The PRIA process is separate and independent of the IRB review process. Submit PRIAs in the PROTRAK (PQS) system.
For more information, please access the Resources section of PROTRAK (PQS) here: https://clinweb.cc.nih.gov/pqs.
Related Resources
To provide PRIA information use this link to access the PQS system: PQS/OPS.