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.

Range of services

Assistance in filing the application

Together with the Clinical Trials Unit UMG we support grant applications concerning biostatistical and data management aspects. Particularly, this includes assistance with:

  • Choice of primary and secondary endpoints
  • Choice of a suitable study design
  • Calculation of sample size and power
  • Choose of appropriate database solutions

Data management and off-site Monitoring

Results of clinical trials have to be collected reliable and in high quality to be plausible. Our data management supports you with these requirements by:

  • Creation of web-based databases in secuTrial®
  • Support with choice of items and assistance in conception of questionnaires
  • Configuration, validation and versioning of electronic case report forms (eCRF) for data collection
  • User management and user support concerning eCRF
  • Support in  pharmacovigilance, e.g. reporting of (suspected/unexpected) serious adverse events
  • Creation of data management specific documents like safety reports, e.g. for  administration, ethics committee, data monitoring committee
  • Query management/off-site data checks for securing high quality data
  • Database lock at end of the trial
  • Data Management REDCap

Data Management REDCap

What is REDCap? 

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.

  • As an administrator/project creator, you are responsible for training other employees in your project. In particular, you must inform them about the terms of use.
  • 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.
  • In addition to these terms and conditions, the use of REDCap is also subject to the Terms of Use of Vanderbilt University (USA, Tennessee). In particular, this excludes commercial use of the data base. See: Link
  • 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")
  • Creation of publication-ready graphics
  • Publication of trial protocols

Contact

Ansprechpartner

Dr. Thomas Asendorf

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Ansprechpartnerin

Sabine Hanß, Dipl.-Inf.

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