Course Content
Clinical Research Data Management Course

The first step in protocol translation is identifying the information required to answer each objective.

Consider the following example.

Study Objective

To determine whether Drug A reduces fever within 48 hours among children aged under five years.

 

To answer this objective, researchers need data such as:

 

  • Participant age
  • Treatment allocation
  • Baseline temperature
  • Follow-up temperature
  • Time of assessment
  • Clinical outcome

From this objective, a data manager can identify variables that must be collected.

 

Objective Component Required Variable
Child age age_months
Treatment group treatment_arm
Baseline fever temp_baseline
Follow-up fever temp_48hr
Outcome fever_resolved

This process is known as variable identification.