Your Easy Guide to Clinical Studies

The SP-INV or Site-INV is responsible for the integrity and quality of collected study 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 life participants who signed the ICF and agreed 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, copied, changed or adapted data)

 

In order to guarantee the quality of study data, an independent study monitor (e.g. not part of the study team) should monitor the compliance with the listed points above, and as applicable implement Corrective and Preventive Actions (CAPAs) (e.g. risk-control-measures).

As a SP-INV:

• Implement a data monitoring strategy for your study
• Ensure that any collected data:
  • Corresponds to the original source-data
  • Stems from participants that have signed the ICF and agreed to participate in the study
• Ensure corrections defined in the monitoring report are implemented
• Review implemented risk-control-measures in order to protect data integrity and quality on an ongoing basis
• Ensure study staff is trained on data collection and data entry procedures

 

Data monitoring is performed either through an on-site visit at the study site, or remotely by gaining access to the study database.

 

Errors found during monitoring should be investigated (e.g. route-cause). This is done by starting a query resolution process.

• The monitor raises a query which is forwarded to the study staff
• The study staff answers the query, and as applicable corrects the error
• Upon query resolution the monitor closes the query

ICH GCP E6(R2) – see in particular guidelines

• 5.5. Trial Management, data handling, and record-keeping