What is it? Why is it important?

Is the implementation of technology to automatically process data in order to convert it into more useful information or formats (e.g. age upon study start, BMI based on height and weight).

Data processing can be done before or once the data has been entered in the database. Still, automated processing might have an important advantage, as it excludes human calculation errors.

Automated processing requires:

  • An electronic database
  • Ability to program processing procedures (e.g. calculations, classification)
  • Ability to perform applicable validations

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 but automated processed data.

What do I need to do?

Based on data needed to answer your study question:

  • Define which data (variables) must be obtained through automated processing
  • Define which variables are needed for the automated processing
  • Ask your data manager to program any required automated processing procedure(s)
  • Include upper and lower limits to the outcome variable(s) in order to detect potential input errors
  • As processed data must be carefully tested and validated, include a test phase to ensure automated data processing is correctly implemented
  • Describe any automated processing in the DMP

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
  • CTU – Clinical Trials Unit
  • DMP – Data Management Plan
Development ↦ Data Handling ↦ Study Database ↦ Automated Data Processing
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): Development ↦ Data Handling ↦ Study Database ↦ Automated Data Processing

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