Concept↦Data Handling↦Stakeholders↦Data Manager
Was betrifft es? Warum ist das wichtig?
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 (e.g. guaranteed 24/7 access / if applicable, crucial for participant randomisation)
- Perform CRF change requests from the SP-INV. Changes to the study CRF might require a protocol amendment approved by EC/ if applicable RA (e.g. Swissmedic)
- Support data quality 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
Was muss ich befolgen?
As a SP-INV, establish a requirement profile for a DMan. Among others, a DMan should be able to help you to:
- Decide on a CDMS which complies with regulatory requirements, and who can perform its initial installation and validation, including server maintenance
- Support the selection of variables needed to answer your study questions, and plan the set-up of the study database (eCRF)
- Write up the Data Management Plan (DMP) of your study
- Implement CDMS updates during study conduct
- Guarantee the smooth running of your database during study conduct and completion (e.g. train staff on data entry, manage personalise access, implement change requests, import and export of study data, archive the study database at the end of the study)
During study conduct the DMan is the main contact person regarding the management of the study database, and the provision of professional support (e.g. study staff, SP-INV, Site-INV, statistician, study monitor, applicable partners)
Mehr
The following sites might be helpful:
- GCDMP: Provides a reference to clinical data managers in their implementation of high quality clinical data
- CDISC: 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
- ECRIN: 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
Wo kann ich Hilfe anfordern?
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
External Links
GCDMP – Good Clinical Data Management Practice Guide
CDISC – Provides standards in the clinical research process
ECRIN – see in particular
- Data certification standards
References
ICH GCP E6(R2) – see in particular guideline
- 5.5. Trial Management, data handling, and record-keeping