News from Clinical Research Office of the Endourological Society (CROES)

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AND ITS NAME IS .…. DMS Version 3.0.x

Introduction

The Clinical Research Office of the Endourology Society (CROES) was founded during the World Congress of Endourology (WCE) meeting 2008 in Shanghai. It is responsible for organizing, structuring, and favoring a global network on endourologic research. To facilitate the collection of endourology research and clinical data, it was decided to create a worldwide data management system (DMS). We now in 2016, almost 8 years later, know that this was extremely successful with the worldwide collection of unique clinical research data in several studies that resulted in many highly significant scientific publications. This is for sure a major scientific milestone in endourology, and it was only possible because many endourology society members worldwide put an enormous amount of work into the collection of these unique data sets. Looking at the results, I think that each member who contributed should be very proud: you are changing the endourologic world.

By end 2009, we have been working very hard to implement a DMS to facilitate the goals of the CROES. Beginning 2010, we started the collection of CROES data through this web-based DMS. Our main goal was to create a very user-friendly system with very advanced features for the involved data managers. Now, we can conclude that we have succeeded! Without any problems, every day, many users of the system are entering very important data.

The CROES started by end 2009 with its first newsletter: “AND ITS NAME IS .…. CROES”. ¹ It is now time for a major new step: “AND ITS NAME IS .…. DMS Version 3.0.x.” The DMS was born in 2009 and has grown since then (from version 1.0 to version 2.1), and now in 2016 it is really mature. In this newsletter, I update you on the status and the major improvements in the new version 3.0.x of the professional DMS.

Secure and Reliable Data Storage

Many are storing (clinical) data in the DMS and, therefore, the data should be stored in a secure and reliable environment. It should be guaranteed that your data are stored in such a way that only you and the data managers have access to the data and that, for example, data corruption or data loss is impossible. How do we guarantee that?

Validated Data Storage

It is important that your data are stored in a validated system. Validation demonstrates that the system fulfills the user requirements and that, for example, data safety is guaranteed. Version 3.0.x of the DMS has been fully validated and the final validation report states: The validation process determined the system and user requirements and these requirements were validated. All requirements have been tested according to the project validation plan. Based on the results as presented in the validation traceability matrixes document, it was concluded that version 3.0.x of the DMS fulfills all system and user requirements: it functions according to the requested requirements. Furthermore, the system was found to be 21 CRF 11 compliant. A safety analysis, focusing on misuse of the system and/or data, potential data loss, and/or data corruption and nonintended use of the system, was performed and the risk of possible safety issues and potentials hazards were considered to be (very) low.

What Is New in Version 3.0.x?

The system now supports multiple DMSs. Thus, next to the CROES DMS, it is now possible to support other DMSs.

The system now supports multiple languages. In version 3.0.x, English and Dutch are available. A Spanish version is already implemented, however, and is still to be checked by a native Spanish speaker. We can implement every language wanted.

The user interface has been further improved. All screens have now the same layout and thus the interface is now even more intuitive.

Design of studies and all forms can now be done online. We implemented a very user-friendly interface by which, for example, data managers can define the forms and all data entry fields.

Help information. Our users do not need to read (long) manuals to understand the possibilities of the system. To help (novice) users, in almost all screens there are now help buttons with (short) help information and tips and tricks. We are sure that this will facilitate (novice) users in an optimal use of the system.

Data entry fields help information. All data entry field can now be defined with a help button. This enables the designers of the study to add help information to a data entry field. For example, additional information regarding a question in a questionnaire.

User feedback. We now have a “feedback” button on every page. Clicking the button enables the user to send directly a message without leaving the DMS. In this way, you can easily send your comments and questions. Please do use this. With your feedback, we can further improve the system.

User licensee agreement. We now have a fully validated system, which implies also that every user has to (electronically) sign our user licensee agreement. This is a legal agreement that arranges some logical arrangements, for example, that we will do our utmost best to make the system available at all times and that the user will not make his or her username and password public. Furthermore, the user agrees that his or her electronic signature is a legal binding replacement for a handwritten signature (according to 21 CRF 11).

Study documents. Studies can now have documents. When you select a study, the documents will be presented in a drop-down list. Selecting a document enables downloading the document. For example, a study protocol can be downloaded (and printed).

Status fields. Opening a study shows the already entered patients in a list. We have added very intuitive status fields to the list. It is very obvious which patients have, for example, still missing data or reminders.

Label links. Labels show some (static) text on a form. It is now possible to add a link to an external webpage. For example, clicking the label “Click here for the inclusion criteria” will open a new window with an external webpage showing the inclusion criteria.

Upload files. Another new data entry field has been defined. When such a field is available in a study, you can upload files into the DMS. For example, to upload a CT image or a text report.

Download of data. Data managers can define download definitions. When you have the rights to download data, clicking a download definition will enable you to download data from the system.

Reports. Data managers can define report templates. When you have the rights to use these reports, clicking a report definition will enable you to download the report in a PDF file.

Reminders. I like reminders. Why? It ensures that you will be reminded to fill in data. For example, after 12 months after an intervention, you will get a reminder to fill in the 12 months follow-up data. Very useful, you do not have to remember this yourself.

Snapshots. Also a new option. The data managers can now “freeze” the study data at a certain date/time. An exact copy of the data and all, for example, download and reports templates are copied to a separate folder. At any time, the data managers can access and, for example, download the “frozen” data (read only). This enables to store the source data of a study at the time of the data analysis, for example, a publication. You thus will always have access to the data at the time you did the data analysis.

Conclusion

Based on our experience since 2010, the DMS version 3.0.x is a major step forward, and the DMS is now a very user friendly and advanced (clinical) DMS. For more detailed information regarding the new version, please do visit www.ts-innovations.com. Most importantly, please do send us all comments, questions, and possible complaints you have. You can do that through the feedback button now available in all screens in the DMS. Furthermore, do not hesitate to send us an e-mail at info@ts-innovations.com. Every response, positive or negative, is very welcome. With your help, we will be able to provide the best possible care to our patients.