What is it? Why is it important?
In studies, the purpose of Data Management (DM) is to enable the gathering of high-quality and reliable clinical data, that can subsequently be used for statistical analyses.
Study data must be of high quality as it provides confidence in study results. Credible study results provide an important basis for further research and contributes to the development of future IMPs, MDs, algorithms, etc.
DM sets the framework that ensures that these aims are met.
- The generation of a Data Management Plan (DMP) is a document that outlines the life cycle of study data, describing how data is generated, collected, documented, shared and preserved
- The choice and implementation of a study database.
- To ensure the database provides for data traceability (audit trail) , safety (e.g. infrastructure, access rights) and confidentiality
- The ongoing quality evaluation of study data, based on error surveillance and correction proposals (e.g. automatic data checks and remote monitoring)
- The export and provision of study datasets ready for statistical analyses
What do I need to do?
When planning your study:
- Define your DM strategy to be elaborate in your DMP
- Define how to ensure the ongoing quality of yours study data (quality checks)
- Include DM tasks in study work load and planning
- Include DM aspects in your budget
Based on the study protocol you need to decide on:
- A list of variables needed for the evaluation of your study
- The DMP that describes the set-up and management of your data during study implementation
- The study CRF that can either be in paper or in an electronic form
- Quality control procedures of any collected data
In many instances it might be an advisable to outsource DM services.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
ICH GCP E6(R2) – see in particular guideline
- 5.5 Trial management, data handling, and record-keeping