OCNRC | Quality Assurance

Quality Assurance

Our Quality Assurance department conducts weekly checks on source documentation and Case Report Forms (paper and electronic) to ensure compliance with Code of Federal Regulation and GCP/ICH guidelines. In addition, our Principal Investigator conducts daily reviews of all reported Adverse Events and Concomitant Medications for proper documentation. We have a dedicated Regulatory Coordinator to ensure proper submission, filing and documentation of regulatory documents between site to Institutional Review Board and Sponsors.

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