Monitor clinical

A clinical monitor, also known as a Clinical Research Associate or CRA for short, is a medically qualified employee of the sponsor or Clinical Research Organisation (CRO) in clinical trials. The task of the monitor is to review and ensure data quality and regulations, including the Declaration of Helsinki, the implementation of Good Clinical Practice (GCP) and compliance with the protocol. Monitoring can significantly improve data quality in clinical studies. Clinical Research Associates are used in studies according to AMG (German Medicines Act) and MPG (Medical Devices Act). In principle, monitoring is required or recommended for all clinical studies, including non-interventional studies, because CRA monitoring is a recognized quality feature of clinical studies.

For this purpose, monitor visits are carried out in the study centers, where the CRA compares the source data with the CRF (Case Report Form) and thus carries out a Source Data Verification (SDV). If the data is implausible or incomplete, queries are sent to the study center, i.e. questions or error messages about the source data or the Case Report Form (CRF) or about incorrect conversions of the trial protocol. As a rule, the investigators and study nurses can answer the queries, while the sponsor is also informed by the CRA in the event of serious violations of the protocol or of the law.

The monitor also checks whether the trial site has reported Serious Adverse Events (SAE) and, if necessary, informs the sponsor if the trial site fails to meet its obligations. A further task of the CRA is to check whether the patients/test persons have been informed before the study starts and whether the signed informed consent form is available. The monitor also maintains the Trial Master File (TMF). Among other things, the Patient Identification List, the training list of the study nurses and the correspondence with the Ethics Committee are stored here.

In order to ensure that the monitoring process is the same in all study centers, a monitoring manual and SOPs (Standard Operation Procedures) are created before the study starts. These describe all procedures in a binding manner and also define the contents of the selection visit (pre-study visit), the initiation, the routine visits (monitoring visit) and the final visit (close-out).