What is it? Why is it important?
A Clinical Data Management System (CDMS) is a type of software used to record, structure, summarise and manage all data collected from and about participants during the implementation of a study.
Selection should be based on applicable requirements such as:
- Conformity to regulatory requirements
- Means and methods to map study design
- Means and methods used for data entry
- Data storage requirements
An electronic CDMS:
- Allows for a structured format-controlled data entry system
- Facilitates data handling such as:
- Regulates user access control
- Allocates applicable user rights such as selected data entry control or modification control
- Facilitates multi-centre studies
- Allows for ongoing backup and the archiving of data
What do I need to do?
As a SP-INV, make yourself familiar with:
- Different CDMSs and their ability to accommodate the specific setup and design of your study
- Regulatory requirements and the ability of the CDMS to manage and fulfil ICH GCP, Ethics (EC), and regulatory demands.
In order to ensure regulatory requirements are met, consult a professional data manager for advice when selecting a CDMS. In addition, the set-up and running of a CDMS (e.g. installation, validation, ongoing software updates, server management) requires extensive expertise and knowhow, and is best managed by a qualified data manager.
The CDMS used in the study should:
- Be based on the riks-based QMS implemented by the SP-INV (e.g. SOP regarding CDMS operations)
- Be able to handle all study specific requirements as described in the study protocol
- Have limited and regulated access control
- Ensure the integrity of all study data, including an audit trail that documents what data was entered at what time point and by whom
- Be validated by the SP-INV prior to being used in the study
- Be able to provide for an ongoing back-up systems
In order to facilitate ongoing data handling during study conduct, select a CDMS that provides an ongoing overview of the current data entry status (e.g. which visits or data entries are complete, which ones are still open or missing).
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
ClinO – see in particular article
- Art. 45 Data retention requirements
HRO – see in particular article
- Art. 5 Storage of health-related personal data and biological material