What is it? Why is it important?

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 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, 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.

What do I need to do?

Implement a data monitoring strategy for your study and ensure that any collected data:

  • Is based on specifications given in the study protocol
  • Correspond to the original source-data
  • Stems from participants that have signed the ICF and agreed to participate in the study
  • Document potential deviations and define applicable control measures
  • Ensure data corrections and applicable improvement measures are implemented
  • Review implemented risk control measures on in order to protect data integrity and quality on an ongoing basis

 

For more information refer to Quality and Risk and Monitoring in this Study Guide.

More

Data monitoring can be performed by visiting the study-site, or remotely by gaining access to the study database at a location other than the study site.

When errors are found during data monitoring, the source of the error should be investigated. This is done by starting a query resolution process.

  • The monitor raises a query which is forwarded to the site staff of the study
  • Once a query is answered by the applicable study staff and the error is corrected, the monitor can close the query

Corrective or preventative measures might include adaptations to data collection and data entry processes including retraining of study staff.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guidelines

  • 5.5. Trial Management, data handling, and record-keeping
Abbreviations
  • CTU – Clinical Trials Unit
  • ICF – Informed Consent Form
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Data Handling ↦ Data Quality ↦ Responsibility
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Data Handling ↦ Data Quality ↦ Responsibility

Please note: the Easy-GCS tool is currently under construction.