What is it? Why is it important?
Central Data Monitoring (CDM) is a central review of the accumulating data in the study database.
The monitor remotely accesses and evaluates study data. This is only possible when data is captured electronically (e-CRF). A data scientist, a statistician, or medical reviewer can also perform CDM.
CDM that often includes statistical data analysis (called central statistical monitoring) 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)
Sites with poor performance or problematic issues detected during centralised monitoring might best be solved by performing an on-site visit.
In a multicentre study, 4 of the 5 participating sites reported headaches in at least 30% of the participants. At one site with 50 participants, no headaches were reported. This raises concerns regarding site adherence to study safety reporting requirements. This issue, which was detected remotely, may trigger on-site visits to investigate the root cause and to impose corrective measures.
What do I need to do?
As a SP-INV, define CDM tasks such as:
- Study data checks that can be performed in the study database, such as data completeness, plausibility, consistency checks, including checks for outliers such as unexpected data based on its normal distribution
- Checks of important data (e.g. data related to the primary endpoint)
- The statistical monitoring approach with support from a statistician. Especially in multicentre studies, inter-site comparisons can provide additional information
- CDM can be more cost-effective, as it can be used to complement and thereby reduce the extent and/or frequency of on-site monitoring
- Is particularly important in multicentre studies as it helps keeping oversight regarding the conduct and performance at study sites. The implementation of CDM is thus highly recommended in large multicentre studies
- Strategy and checks should be specified in a CDM plan and documented in CDM reports
For more information refer to Data Handling in this Study Guide
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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