Your Easy Guide to Clinical Studies

The SP-INV or Site-INV is responsible for the integrity and quality of collected data.

 

This entails that data collected and entered into the study database (eCRF):

• Is according to specifications given in the study protocol
• Originate from real participants and who have signed the ICF, thus agreeing to participate in the study
• Correspond to the source-data from where the data was originally collected
• Is not based on fraud with the aim to manipulate study outcome (e.g. invented, changed, copied or adapted data)

 

Quality data is reproducible data. In other words, data has been collected and managed in such a way that other researchers obtain similar results when repeating the study.

As a SP-INV implement a data monitoring strategy for your study and:

• Document any data related protocol deviations (i.e. create a note-to-file)
• Define any risk-control-measures and ensure corrective measures (e.g. CAPAs) are trained and implemented
• Review risk-control-measures for applicability and efficacy on an ongoing basis in order to ensure data quality

 

Data monitoring can either be performed by an on-site visit or remotely through central data monitoring (i.e. monitoring gains access to the study database at a location other than the study site).

 

When errors are found its route cause should be investigated. This includes a defined query process, where:

• The monitor raises a query which is forwarded to the study staff
• The study staff assesses the query and makes applicable comments and or corrections, which can be viewed by the monitor
• Resolved queries are closed

References

ICH GCP E6(R2) – see in particular guidelines

• 4.5 Compliance with the protocol
• 5.5. Trial Management, data handling, and record-keeping