Basic↦Data Handling↦Study Database↦Study Data
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 required study data should be specified and documented in the study protocol.
For the statistical analysis only digital data can be used. Still, in studies also non-digital data formats can be collected (e.g. laboratory notebooks, participant diaries, interviews). Consequently, any non-digital data must initially be translated into some type of coded format prior to being used for statistical analysis.
Typical data to be collected in a study are:
- Descriptive data (e.g. age, gender, demographics)
- Information on patient consent
- Data required to answer the primary and secondary research questions of a study (e.g. disease characteristics, efficacy data, observational data)
- Safety data reported by study participants (e.g. experienced adverse events during study participation)
What do I need to do?
Only data needed to answer the study question should be listed in the study protocol and consequently collected during study conduct.
The excessive collection and documentation of data not needed to answer the study question:
- Adds unnecessary burden to study participants, which is considered 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 study cost and thus required funds
For more information refer to Feasibility in this Study Guide.
Health related data is considered sensitive data. Thus, special handling and management of such data is required in order to protect the identity of study participants.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch