Info

Clinical Research Data

Objective: Make data management processes more efficient, improve data quality and enable re-use of clinical research data

Rationale

In most clinical studies, data collection and study planning are still largely manual processes.  As a result, they are labor intensive, the chance of mistakes being incorporated is increased and efficient exchange of data is hampered.
Furthermore, once a study is finished, raw data sometimes get 'lost'. Especially when the researchers involved move to a different project or new position, it becomes very hard to retrieve data and verify the analyses. As a result, such data are used only once, whereas it can be of great value to other studies.

Target groups
- Clinical researchers / Principal Investigators
- Clinical research assistants / research nurses / data managers

Approach

After consulting the user groups, priorities have been defined as to which tools and applications are most needed. Those are implemented first, followed by expanding the package in a step-by-step approach. Similar as to all TraIT work packages, WP1 opts for implementing existing solutions and thereby keeps the tailor made development work to a minimum. The latter will mostly apply to setting up interfaces between the TraIT tools that are used for clinical research. If possible, also local connections between the WP1 tools and the systems operated by participating hospitals and research centers will be built.

 

Status

TraIT WP1 has selected OpenClinica in 2011 as a data capture tool where clinical research (meta)data from studies will be collected. Most important reasons for selecting OpenClinica are: it has an Open Source license, is web based, supports all types of clinical studies, no programming/ IT knowledge needed for CRF design and built on leading, independent standards. Within WP1 also tools and utilities have been developed that improve the usability of OpenClinica. Furthermore, TraIT is one of the drivers of further development and improvement of OpenClinica.

In addition, Logis was selected as a scheduling tool to support research personnel in the planning of clinical studies, which will make the process more efficient and transparent. Ldot also has logistic support functionality, such as scheduled Emailing to study participants.

Ldot fits the functional requirements -defined by target users- better than comparable tools. Also, release cycles of this tool are short and wishes of TraIT users are easily taken up in the development.

 

Status summary

- OpenClinica (data capture tool) is in production and ready to be used
- Several tools and utilities are supported that improve the usability of OpenClinica

- Standards for data capture have been defined within individual studies, currently standard CRFs are being developed to facilitate the process of CRF set-up and data sharing.

- Ldot (scheduling tool) is in production and ready to be used
- Interoperability between OpenClinica and Logis is developed

 

Link to tool pages

More information about OpenClinica and TraIT OpenClinica services can be found via on our website
More information about Ldot and TraIT Ldot services can be found via our website

More information
Work Package leader: Marinel Cavelaars (The Hyve)
marinel <at> thehyve.nl