What is it? Why is it important?

In order to reduce potential input errors in the study database (eCRF), variables can be specified with additional technical constraints or edit checks.

 

Input constraints include:

  • Format: Only allows input based on a pre-defined or standardised coding list, date format, lab value format (e.g. haemoglobin as g/l or g/dl)
  • Range: Limit potential input based on an upper and lower limiting value
  • Length: Limits input to a maximum of characters or number digits
  • Branching: Some variable are only answered if a specific answer of a preceding question is selected (e.g. are you pregnant? Yes - addition questions)

 

Navigation options can reduce input errors:

  • Selection: Multiple choice, drop-down menus, radio buttons facilitate and guide staff during data entry
  • Support: Information provided to indicate how to fill in the related input field
  • Warning message: displayed when:
    • Incorrect data is entered
    • Missing manatory data, value, or checkbox 

What do I need to do?

As a SP-INV, go through the list of selected study variables and for each variable define applicable technical requirements:

  • Type of variable (e.g. direct input, single option, multiple options)
  • Accepted range for numeric or date time variables
  • Selective conditions (e.g. show or hide variables under certain conditions)
  • Form name for each group of variables

 

In addition:

  • Define the chronology and decide when a particular form must become visible for data to be entered (e.g. order of visits and collection)
  • Select metadata standards for coding your data (e.g. CDISC, CTCAE)

 

For the database set-up:

  • Define and document in collaboration with the data manager all technical requirements including its rational 
  • Upon database set-up include a test-phase(s) to ensure planned specifications and its navigation are implemented as intended
  • Upon the successful completion of the test-phase, confirm the release of the study database into the productive phase (e.g. input of real-life data)

 

A user-friendly and fit for purpose database (eCRF) will ensure that collected study data will be of high quality.

Where can I get help?

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

External Links

CDISC – Provides standards in the clinical research process

CTCAE – Common Terminology Criteria for Adverse Events

References

ICH GCP E6(R2) – see in particular guideline

  • 5.5 Trial Management, data handling, and record-keeping
Abbreviations
  • CDISC – Clinical Data Interchange Standard Consortium
  • CRF – Case Report Form
  • CTCAE - Common Terminology Criteria for Adverse Events
  • CTU – Clinical Trials Unit
  • eCRF – electronic Case Report Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • SP-INV – Sponsor-Investigator
Development ↦ Data Management ↦ Database Development ↦ Specification
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 Statistic Methodology
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 Statistic Methodology
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 Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Data Management ↦ Database Development ↦ Specification

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