What is it? Why is it important?

Study data is any information that is collected or generated during study conduct, and which is needed to answer its primary- and secondary research questions.  Any data collected during the study must be specified and documented in the study protocol.


For the statistical analysis only digital data is used. Still, in studies also non-digital data formats are collected (e.g. visual imaging, laboratory notebooks, participant diaries, interviews). As a consequence and prior to analysis, non-digital data must initially translated into some type of coded format.


Typical data collected in a study are:

  • Descriptive data (e.g. age, gender, demographics)
  • Study relevant data needed to answer the research question(s) (e.g. disease characteristics, intervention efficacy data, observational data)
  • Safety data, with the collection of adverse events experienced by study participants  during study conduct

What do I need to do?

As a SP-INV, know that only data needed to answer the research question(s) can be collected. In addition, all planed study data must be listed in the study protocol and submitted to the Ethics Committee for approval (e.g. sommarised in the CRF of the study).


The excessive collection and documentation of data not needed to answer the study question(s)

  • Adds unnecessary burden to study participants and is consequently unethical from a participant perspective
  • Will increase the required resources needed to perform the study (e.g. infrastructure, study staff, handling and analysis of biological samples)
  • Will increase the cost of the study and inflate the study budget


Prior to collecting any data from study participants requires that they consent (ICF) to study participation. Health related data is considered sensitive data. Thus, special handling and management is required to ensure the identity of study participants is protected.


For more information refer to study Feasibility in this Study Guide.

Where can I get help?

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

  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • ICF – Informed Consent Form
  • SP-INV – Sponsor Investigator
Basic ↦ Data Handling ↦ Study Database ↦ Study Data

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

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

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Basic ↦ Data Handling ↦ Study Database ↦ Study Data

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