Monitoring activities

Clinical research associates (CRAs) are responsible for study monitoring activities. Together with the Study Manager they train, support, and guide the study team. They also serve as contact person in case of queries from sites. Moreover, the team of CRAs is responsible for the collection and timely forwarding of essential documents and compilation of the trial master files. During study conduction they verify the compliance with the performance study plan and the GCP-conform documentation. They check the collected data for accuracy, completeness, legibility, plausibility and conduct source data verification. In addition, CRAs ensure that severe adverse events (SAEs) and/or severe adverse device effects (SADEs) are correctly reported in accordance with legal regulation and forwarded to the sponsor who reports them to the authorities, if necessary. Thus, monitoring is a key role for a successful study conduction.

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