What is it? Why is it important?

Callcualted Fields (CF) are programmed activities in the study database (eCRF) to convert data into a more useful format or needed information (e.g. age upon study start, BMI based on height and weight). CFs have an important advantage, as they are automatically processed and therefore exclude human calculation errors.

 

Required calculations can be done either when the data is entered in the study database (pre-processing) or after being exported (post-processing)

 

CFs require:

  • An electronic database (e.g. CDMS)
  • Ability to program calculations (e.g. formula, classification)
  • Validation procedures to ensure automated processing was correctly implemented

 

Example

Calculation of creatinine clearance requires the input of raw data into an applicable formula (age, weight, serum creatinine, and gender). Upon automated data processing the creatinine clearance number is no longer raw data (e.g. source data) but automated processed data.

What do I need to do?

As a SP-INV, and based on data needed to answer your study question:

  • Make a list of study data (variables) that can be obtained through automated processing

 

For pre-processing:

  • Define which variables must be available
  • Ask your data manager to program the required calculation(s) in the study database
  • If needed, implement alerts for upper and lower calculation limits
  • Include a test phase to guarantee that pre-processing calculations are correctly implemented. Document the implemented validation procedures

 

For post-processing:

  • Define which variables must be available for data export (e.g. for analysis)
  • Ask your data manager or statistician to program the required calculation(s) based on the raw data
  • Include a test phase to guarantee that post-processing calculations are correctly implemented Document the implemented validation procedures

 

Describe any automated processing in the study protocol, DMP and/or SAP

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 guideline

  • 5.5 Trial management, data handling, and record-keeping
Abbreviations
  • CDMS – Clinical Data Management System
  • CF – Calculated Fields
  • CTU – Clinical Trials Unit
  • DMP – Data Management Plan
  • eCRF – electronic Case Report Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • SAP – Statistical Analysis Plan
Development ↦ Data Management ↦ Database Development ↦ Calculated Fields
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 ↦ Calculated Fields

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