Your Easy Guide to Clinical Studies

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

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.