3TU.Datacentrum Symposium 2014 Barry Ruijter, PhD student TNW-MIRA, University of Twente Practice of data management in clinical research
Jun 18, 2015
3TU.Datacentrum Symposium 2014
Barry Ruijter, PhD student TNW-MIRA, University of Twente
Practice of data management in clinical research
My PhD project: a brief introduction • Monitoring brain activity with EEG (electroencephalography) in
comatose patients after a cardiac arrest
• Core research questions: • Can we use EEG to predict whether patients will wake up or not? • Does (anti-epileptic) medication increase the chance of recovery?
Data collection
• Data types • EEG data
• Case Record Forms: contains e.g. demographic data, information on diagnosis, treatment, and outcome
• Research sites • Currently: 5 hospitals in The Netherlands
• More hospitals will be recruited in the near future (possibly outside The Netherlands)
Laws and regulations
• WMO (Dutch act of medical research involving human subjects) • Privacy protection: no data may be traced back to the person involved
• A unique fictive code must be used, the encryption key must be secure
• Good clinical practice (GCP): international guideline on ethical aspects of clinical research • Intended to protect human subjects and validity of data
• An audit log is necessary to keep track of changes in data
• Data must be kept for 15 years after completion of the trial.
• Funding party (Epilepsiefonds: Dutch Epilepsy Foundation): no specific data management requirements
EEG data logistics: current practice
Case record forms: current practice
In the near future: electronic Case Record Form in OpenClinica • Web-based, open source data management system
• Needs server installation
• Intended for clinical research purposes, in concordance with GCP
• CTMM (Center for Translational Molecular Medicine) offers a free server for OpenClinica for non-commercial research. However: only funded until the end of 2014.
• Our intention: OpenClinica installation on local data server (University of Twente)
OpenClinica: evaluation
• Advantages: • No need for manual collection of Case Record Forms (CRFs)
• Permissions depend on role (e.g. investigator, study monitor), according to Good Clinical Practice guidelines
• Audit logs are created automatically
• Disadvantages: • Does not have a randomization module
• No possibility to upload other data types (e.g. EEG data)
• The way to design a CRF is not user friendly
Questions?
Randomization of study subjects
Practical considerations
• EEG data • preferably stored in central database
• large files, may take a long time to upload
• Case Record Forms • preferably collected in digital forms and stored in central database
• may not contain privacy-sensitive data (e.g. birth dates)