Your Easy Guide to Clinical Studies

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
• Perform CRF change requests from the SP-INV. Changes to the study CRF might require a protocol amendment approved by the Ethics Committee EC and if applicable RA (e.g. Swissmedic)
• Perform data quality checks (e.g. central monitoring)
• Perform data imports and 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

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
• Support the design of forms, and plan the set-up of the study database (eCRF) 
• Support the write up the DMP of your study
• Allow for the smooth running of your database during study conduct and completion (e.g. train staff, 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. access control, system error management)

External Links

GCDMP – Good Clinical Data Management Practice Guide

CDISC – Provides standards in the clinical research process

ECRIN – see in particular

• Services / Data Centre Certifications

References

ICH GCP E6(R2) – see in particular guideline

• 5.5. Trial Management, data handling, and record-keeping