What is it? Why is it important?
In studies, the aim of Data Management (DM) is to support researchers in the collection and management of their study data. DM ensures that study data is handled in compliance with the law (e.g. Swiss law, Data Protection law), ICH GCP, Ethical (EC), and applicable regulatory requirements (e.g. Swissmedic, international). By selecting an appropriate Clinical Data Management System to manage study data, DM contributes to the generation of high-quality data needed for the statistical analyses.
High quality data provide confidence in study results, which are an important basis for further research and the ongoing advancement in science (e.g. development of medicinal products, treatment procedures algorithms).
What do I need to do?
As a SP-INV familiarize yourself with DM tasks involved in the planning and set-up of a study database.
Typical tasks include:
- To select a Clinical Data management System (e.g. CDMS) that complies with the law (e.g. Swiss law) and ICH GCP (e.g. infrastructure, database validation, audit trail, access protected, data back-up)
- To perform and validate the installation of a CDMS, including software updates
- To write applicable SOPs and WIs for the set-up, implementation, and closure of a study database
- To define a Data Management Plan (DMP) for the study (e.g. outlines the life cycle of study data and describes how data is generated, collected, documented, shared and preserved)
- To support the Site-INV in the design of a study Case Report Form (eCRF) (e.g. study variables, visit plan, randomisation)
- To close and archive the study database at study completion
- To export data for statistical analysis
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
ICH GCP E6(R2) – see in particular guideline
- 5.5 Trial management, data handling, and record-keeping