What is it? Why is it important?
The Data Manager (DMan) works in collaboration with the SP-INV to ensure that study data is appropriately collected and managed.
Responsibilities include to:
- Support the write up of the DMP outlining how data will be collected, documented, stored, shared and preserved
- Design the study eCRF including its metadata specifications
- Train staff on eCRF data entry including applicable rights and access control
- Put the database into operation and ensure it remains fully operational during study conduct
- Perform quality and data integrity checks during study conduct (e.g. central monitoring)
- Support and implement data exports
- Implement randomisation processes including blinding/unblinding procedures
- Manage the CDMS updates and perform applicable electronic system validations
- Locks and archives the study database at the end of the study
During study conduct the DMan is the main contact person regarding database management (e.g. access control, system error management).
What do I need to do?
Select or hire a qualified DMan who can help you:
- Plan the set-up of the study database including the defintion of required DM tasks applicable to your study
- Decide on a CDMS which complies with regulatory requirements
- Design and implement an eCRF able to include all required study variables that have to be collected from participants
- Provide applicable DM training to local staff and answer related questions
Evaluate whether to outsource DM tasks to professional service providers.
The following sites might be helpful:
Provides a reference to clinical data managers in their implementation of high quality clinical data
Provides standards in the clinical research process. It is geared towards establishing clinical data standards to ensure data remains valuable and relevant. Having common data standards greatly facilitates data sharing, essential with the aim to further clinical research
Provides data certification standards intended to describe good practice in data and IT management in clinical research. They also conduct audits and issue respective certifications
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
GCDMP– Guidance tool for clinical data managers for implementation of high-quality clinical data
CDISC – Provides standards in the clinical research process
ECRIN – see in particular
- Data certification standard – Provides data certifications standards
ICH GCP E6(R2) – see in particular guideline
- 5.5. Trial Management, data handling, and record-keeping