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The clinical studies are performed in strict accordance with appropriate safety regulations and the Declaration of Helsinki.
Audit is a systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), GCP, and the applicable regulatory requirements.
As a qualified CRO, Prodia the CRO has certified auditors who will be able to complete your needs in audits procedures to ensure that a site is complying the protocol in conducting a study including regulatory audit requirements.
The audits service including the routine audits and for- cause audits. Audits will include but are not limited to:
A. Study Documents:
Protocols and amendments, EC and regulatory approvals, curriculum vitae, current lab certificates and normal values, drug storage and accountability to include shipping, receipt, dispensing and return records, monitoring records, sponsor and investigator correspondence, investigator brochure, serious adverse events and safety updates.
B. Patient Records:
Patient CRF's, hospital and/or clinic charts, source documents, supporting CRFs, laboratory reports, X-ray, EKG reports, study visit compliance and dosing compliance.
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