What is it? Why is it important?

All collected study data must eventually be entered into the eCRF of the study. How data is collected (e.g. pCRF, laboratory print outs, participant questionnaire) or structured (number of visits, type of variables) depends on the study design.

 

Each participant and event (e.g. study visit) is given a unique identifier. This is important to:

  • Maintain participant confidentiality
  • Ensure any collected data is correctly allocated to the respective participant and applicable study visit
  • Link all study documents and data to the same participant
  • Build a data-set with variables that can be used for statistical analysis and the generation of study results

 

Database set-up or structure can include aspects such as:

  • The definition of a pre-defined number of study visits
  • Randomisation where participants are allotted to different groups
  • Blinded interventions where randomised groups are not-identifiable
  • Standardised code libraries (e.g. ATC or MedDRA coding)

What do I need to do?

As a SP-INV or Site-INV:

  • Delegate data collection and entry responsibilities to qualified staff
  • Ensure staff is properly trained and have ongoing access to the eCRF of the study (e.g. individual access)
  • Ensure a study DMan is available for questions or support (e.g. updates, system failure)
  • Review the data entered in the eCRF to confirm its accuracy
  • Delegate data verification to an independent and qualified monitor

 

Any data analysis performed by the SP-INV during study conduct can only be implemented based on specifications given in the study protocol (e.g. planned interim analysis).

More

Responsibilities of staff entering study data might include to:

  • Compile, sort and if applicable compute source-data in preparation for data entry
  • Review data for deficiencies or errors, including the correction of detected inconsistencies
  • Enter data within given time limits, as it prevents belated queries and potential errors
  • Ensure the exclusive use of personal logins. This guarantees the correct documentation of the audit-trail, regarding what data was entered or changes by which staff member

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
  • ATC - Anatomical Therapeutic Chemical
  • CTU – Clinical Trials Unit
  • DMan – Data Manager
  • eCRF – Electronic Case Report Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • MedDRA – Medicinal Dictionary for Regulatory Activites
  • pCRF – Paper Case Report Form
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Data Management ↦ Data Entry ↦ Collection
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Data Management ↦ Data Entry ↦ Collection

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