Your Easy Guide to Clinical Studies

Central Data Monitoring (CDM) is the central review of data accumulated in the study database. It ensures the logical consistency of the data, thereby guaranteeing data quality.

The monitor remotely accesses and evaluates study data. This is only possible if data is captured electronically (e-CRF). A data scientist, a statistician, or medical reviewer can also perform CDM.

 

CDM checks can be automatic (e.g. incorrect or inconsistent data) or semi-automatic. CDM can be used to identify:

• Missing, implausible, or inconsistent data
• Unexpected or false data (e.g. outliers)
• Systematic errors in data collection
• Trends and inconsistencies (e.g. an unexpected lack of variability)
• Variability within and across sites (e.g. identification of sites with high error rates, relatively high or low number of (serious) adverse events, low participant recruitment)
• Study protocol deviations (e.g. changes in participant visit schedules, specific tests, or medical examinations that were not – or only partly – performed)
• Deviations from database completion requirements (e.g. entry must be done within 5 days after participant visit)

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As a SP-INV, define CDM tasks such as the:

• Automatic study data checks in the study database (e.g. data completeness, plausibility, consistency checks, including checks for outliers such as unexpected data based on its normal distribution)

• Targeted data checks of data that carry greater importance to the study (e.g. data related to the study entpoint / outcome)

• Statistical monitoring implemented by a study statistician. Especially in multicentre studies, inter-site comparisons can provide additional information

 

CDM during study conduct is a good strategy as it:

• Ensures ongoing data quality with easier access to resources (i.e. study staff and study participants are usually more available during study conduct than after study completion)
• Is more cost-effective, as it may reduce the extent and/or frequency of on-site monitoring
• Ensures an evenly dispersed workload rather than validating the entire data-set at study end
• Is highly recommended in multicentre studies as it provides an oversight regarding the conduct and performance of participating study sites

 

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References

ICH GCP E6(R2) – see in particular guidelines

• 5.18 Monitoring activities
• 6.10 Access to source data / documents

ISO 14155 Medical Device – see in particular section (access liable to costs)

• 7.8 Document and data control
• 9.2.4 Monitoring

Documents

• Central Data Monitoring in Clinical Trials