Clinical Research - Review of Medical Results

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Document Purpose

The purpose of this procedure is to ensure that all medical tests conducted for clinical research purposes are reviewed by the Investigator to ensure the safety of clinical research participants, adherence with the protocol and compliance with applicable NSW Health, SCHN and regulatory regulations. This procedure applies to all clinical research conducted within SCHN where the Investigator is responsible for reviewing medical test results to ensure clinical research participant safety and care, as per the protocol. This procedure applies regardless of whether such tests are performed at SCHN or by external agencies, such as central laboratories. Adherence to this procedure will ensure that: * Investigators promptly receive and review medical test results for clinical research participants under their care; * Investigators promptly act to review, escalate, respond and document any decisions made or actions taken, as a result of the review of medical tests to ensure the safety of clinical research participant under their care (as appropriate); and * Investigators respond in compliance with the requirements of the protocol (as applicable) and regulatory approvals, except when necessary to eliminate immediate hazards to the participant as per ICH GCP Section 3.3.7.

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