From site qualification to closeout, ClinDatrix CRAs monitor patient eligibility, protocol implementation, data collection, adverse event reporting, regulatory document maintenance and a battery of clinical study performance metrics to ensure each study’s integrity.
Successful investigator selection and recruitment requires site space evaluation, clinical staff interviews and equipment inspection. ClinDatrix plans, prepares, conducts and reports on each site qualification visit (pre-study screening visit) to ensure successful investigator selection.
Site Initiation Visits
At site initiation visits, our CRAs review the protocol and investigational brochure with the investigator and clinical site staff and provide detailed instructions for CRF/eCRF completion. In addition, the CRA reviews regulatory documents, discusses patient enrollment goals, and reviews safety reporting, query handling and drug and/or device management.
Interim Monitoring Visits
Throughout the course of the clinical investigation, our CRAs monitor the site and perform the following: review informed consent form completion, confirm HIPAA compliance, verify patient eligibility, monitor protocol violations/deviations, perform source and CRF/eCRF data review, retrieve clinical data (i.e., CRFs), monitor adverse event reporting, handle query resolutions, examine reasons for screen failure or withdrawal, review regulatory documents and perform drug and/or device accountability.
ClinDatrix finalizes documentation at the clinical site in preparation for any pending audit by a regulatory agency (e.g., the FDA). At the close-out visits, our CRAs perform final source documentation and CRF/eCRF data review; reconcile regulatory documents; finalize adverse event documentation, patient disposition and query resolution; and retrieve the remaining completed CRFs and resolved queries. Our CRAs also perform final study drug and/or device accountability and return or destruction. Finally, the CRAs review with the site personnel their obligations following study termination.