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 (i.e. study outcome / endpoint).  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 CRF and submitted to the Ethics Committee for approval.

 

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

  • Is unethical, as it adds unnecessary burden to study participants
  • 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.

Where can I get help?

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

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

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