Biometry, Data Management and Informatics in Clinical Trials
Aiming to improve the course of clinical trials the working group Biostatistics, Data Management and Informatics in Clinical Trials was formed. The working group lies at the cross-sections between the Clinical Trials Unit UMG and the Departments for Medical Statistics and Department of Medical Informatics, and supervises clinical trials during application, start, execution and evaluation.
REDCap is a web-based system for creating study databases, developed by Vanderbilt University. REDCap meets all the technical requirements for the implementation of GCP-compliant studies and can be intuitively operated.
REDCap enables you to:
Independently create study databases for data from forms
Collect data on clinical outcomes
Collect patient-reported outcomes electronically:
With of personalized access for patients
Anonymous as a survey (also via tablet or mobile phone)
Involve other users to record the data (no more version problems, no data in the email inbox)
Provide a central database for multicenter studies
Export data with automatic version control and make it available for analysis
To keep an audit trial to document changes to the data
How can I register for REDCap?
An online form is available to register for REDCap: Link
What do I have to consider when using REDCap?
When using REDCap, some rules must be followed to cmply with data protection regulation.
No AMG or MPG studies may be conducted on the UMG instance of REDCap. If you are planning an AMG or MPG study, we can advise you on suitable database solutions.
No personal-identifying data (e.g. surname, first name, date of birth, email, telephone number) may be saved within the data base
The UMG instance may only be administered by UMG employees
Data entry is only permitted after receiving a positive ethics vote.
The use of REDCap on the UMG instance requires the registration of a clinical study through the Research Management (FoMa). See: Link
Here you can find further informative videos on REDCap.
Innovative data collection and integration of external data sources
Some studies require additional types of data collection, which exceed the possibilities of secuTrial® or connections to further data sources are desired in cooperation projects. Here the medical informatics supports:
Patient Reported Outcome Studies
Sensor measurements via wearables
Connection of pseudonymization services
Connection of image data management systems and laboratory information systems
Interim analyses and statistical evaluation of clinical trials
Following data acquisition and database lock the statistical evaluation is performed with special attention to testing of primary and secondary endpoints. Besides the statistical evaluation at the end of trials this includes also evaluations during the trial. The working group handles all necessary biometrical aspects concerning the evaluation of your trial data:
Creation of a statistical analysis plan (SAP)
Intermediate statistical analyses, e.g. sample size recalculations
Descriptive evaluation of patient population
Statistical evaluation of primary and secondary endpoints of different data types
Preparation of meaningful graphics
Assistance with publications
At the end of clinical trials, the results are published. Here we also offer:
Evaluation of specific statistical questions
Explanation of used statistical methods ("Material and Methods")