Data Management
Electronic Case Report Forms (eCRF) shorten the way of data-transmission from the clinical sites to the study center. Data are remotely entered into the database, while being checked extensively. Therefore, a lot of misunderstanding, lacking or incorrect data can be avoided. This reduces the time from the source of the data to the validated storage in the database by weeks or months. Shortly after completion of the last study case the database can be locked and the evaluation will be done immediately.
Problems of spreadsheets
Currently, a large fraction of research data is still captured in spreadsheets software. Such programs are ill-equipped for tasks like access control, change tracking, or plausibility checks. Data structures are usually defined ‘on the go’ rather than planned consistently in advance. Furthermore, they do not force centralized data storage, resulting in diverging versions scattered on various computers, thumb drives, and other media. This is a recurring theme when tracking inconsistencies between analyses done by various people. Data security and data protection are frequently not taken into account. This relates to risks of losing data, data hacking, as well as protection of personal identifiers and sensitive information.
Ill-structured spreadsheets make the transfer into analysis software cumbersome and error-prone. It is not unusual in our projects that more than a working day and more than a thousand lines of code are necessary to import data, that could have been read within 5 minutes if well structured.
Storage of data into centralized data bases can solve many of the problems of spreadsheet.
eCRFs
HealthTwiSt developed a framework for web-based data management for its own research programs as well as the development of customized solutions for external partners. Various clinical studies were performed applying our solutions. Basic research e.g. at the Max-Delbrück-Center for Molecular Medicine profited from this approach as well by managing animal research data, gaining advantages in terms of progress monitoring, data consistency, and speed of access to results.
As designed using HTML, CSS, PHP and JavaScript, our eCRFs are available globally with all modern Internet browsers independent of particular computer platforms. There is no need for installation of plug-ins or special software. For authorized users, this allows the access from any web-connected place worldwide at any time, while still guaranteeing data protection at highest levels. The system is scalable and adaptable to study-specific technical requirements.
Electronic Case Report Forms (eCRF) shorten the way of data-transmission from the clinical sites to the study center. Data are remotely entered into the database, while being checked extensively. Therefore, a lot of misunderstanding, lacking or incorrect data can be avoided. This reduces the time from the source of the data to the validated storage in the database by weeks or months. Shortly after completion of the last study case the database can be locked and the evaluation will be done immediately.
The system traces each modification of the data in the database, to document day, time, and user who did enter or correct the data. In case of changes the original data remain visible.
Real Time Feedback is a major attainment of the Internet-based data collection. Due to the data being stored immediately in a database there is no delay for getting information on the progress of the study or the situation regarding adverse events (AEs). While scientific results should be drawn only from the final collection of all study data, status information can seriously improve trial management.
GCP compliant data management
There are technical requirements regarding physical security and management of storage facilities, depending on customer requirements various levels of protection can be provided.
Sensitive data are encrypted and only visible based on predefined roles with necessity to contact subjects. All data are encrypted during transmission over the internet to or from the trials units.
Access control mechanisms are granular enough so that users only see the data they need to see, e.g. data from their own study site or department or data domain.
Password management rules are enforced on all users, including regular password change and password complexity if requested.
Back Up policies detailing backup policy, procedures, restores and testing are in place, Back ups are taken at least once every 24 hours, using a managed, documented regime. Client-Server replication can be provided as well.