[2.7] practice of data management in clinical research - barry ruijter [3tu.datacentrum symposium...

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)